Canine Guidance vs Bilateral Balanced Occlusion in Complete Denture

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT01420536
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 27.9
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The objective of this study is to compare the canine guidance (CG) and bilateral balanced occlusion (BBO) on denture satisfaction and kinesiographic parameters of complete denture wearers, by means of a cross-over trial. Edentulous patients will receive new maxillary and mandibular complete dentures and, after the intraoral adjustments and adaptation period, will randomly receive a sequence of occlusal schemes: BBO followed by CG, or CG followed by BBO.

Condition or Disease	Intervention/Treatment	Phase
Edentulous Mouth; Edentulous Jaw	Procedure: Occlusal scheme	N/A

Detailed Description

Reference for published version of the complete study:

Paleari AG, Marra J, Rodriguez LS, De Souza RF, Pero AC, De A Mollo Jr F, Compagnoni MA. A cross-over randomised clinical trial of eccentric occlusion in complete dentures.J Oral Rehabil. 2012 Apr 9. doi: 10.1111/j.1365-2842.2012.02299.x. [Epub ahead of print]

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Cross-over Randomized Clinical Trial of Canine Guidance and Bilateral Balanced Occlusion in Complete Denture Wearers
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Canine Guidance Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Procedure: Occlusal scheme; Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept. Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.; Other Names: Dental articulation Denture oclusion
Sham Comparator: Bilateral Balanced Occlusion Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions	Procedure: Occlusal scheme; Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept. Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts.; Other Names: Dental articulation Denture oclusion

Outcome Measures

Primary Outcome Measures

1. Denture Satisfaction [30 days]

   Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).

Secondary Outcome Measures

1. Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

2. Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

3. Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

4. Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

5. Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

6. Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

7. Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

8. Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

9. Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis [30 days]

   Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

10. Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis [30 days]

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

11. Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis [30 days]

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

12. Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis [30 days]

    Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult patients needing new complete dentures

• Mentally receptiveness

• Absence of dysfunctional disorders of the masticatory system

• Normal volume and resilience of residual edentulous ridges

• Absence of debilitating systemic diseases

Exclusion Criteria:

• Use of cardiac pacemaker

• Refusal to participate or inability to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)	Araraquara	SP	Brazil	14801-903

Sponsors and Collaborators

• University of Sao Paulo
• Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Raphael F de Souza, DDS, PhD, University of Sao Paulo
• Study Director: Marco A Compagnoni, DDS, PhD, Araraquara Dental School -Universidade Estadual Paulista (Sao Paulo State University)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Institutional page of the Araraquara Dental School (research site)
• Institutional page of the Ribeirão Preto Dental School (PI's institution )
• Principal Investigator´s CV (RF Souza)
• Study director´s CV (MA Compagnoni)

Publications

None provided.

• Responsible Party: Raphael Freitas de Souza, Assistant Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01420536
• Other Study ID Numbers: Unesp-PT-001; 2008/07183-5
• First Posted: Aug 19, 2011
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Raphael Freitas de Souza, Assistant Professor, University of Sao Paulo: Bilateral Balanced Occlusion; Canine Guidance; Complete Denture; Denture Retention; Dental Occlusion; Edentulous; Edentulism; Mandibular movement; Mastication; Patient Acceptance of Health Care; Patient Satisfaction
• Additional relevant MeSH terms: Jaw, Edentulous; Mouth, Edentulous; Salicylic Acid

Study Results

Participant Flow

Recruitment Details	Recruitment period: July to December 2012. Convenience sample composed by 50 patients, who had volunteered to receive new complete dentures at Araraquara Dental School - UNESP.
Pre-assignment Detail	Participants waited 30 days following the completion of treatment, in order to have them functionally adapted to their new dentures. Six spontaneously declined to participate before random assignment due to lack of interest.

Arm/Group Title	Canine Guidance, Then Bilateral Balanced Occlusion	Bilateral Balanced Occlusion, Then Canine Guidance
Arm/Group Description	Canine guidance: Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions	Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92).
Period Title: Period 1 (30 Days)
STARTED	22	22
COMPLETED	19	22
NOT COMPLETED	3	0
Period Title: Period 1 (30 Days)
STARTED	19	22
COMPLETED	19	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Canine Guidance, Then Bilateral Balanced Occlusion	Bilateral Balanced Occlusion Then Canine Guidance	Total
Arm/Group Description	Canine guidance: Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92); Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions	Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions; Canine guidance: Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92);	Total of all reporting groups
Overall Participants	22	22	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	11 50%	11 50%	22 50%
>=65 years	11 50%	11 50%	22 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.5 (10.6)	66.4 (10.3)	66.0 (10.5)
Sex: Female, Male (Count of Participants)
Female	14 63.6%	14 63.6%	28 63.6%
Male	8 36.4%	8 36.4%	16 36.4%
Region of Enrollment (participants) [Number]
Brazil	22 100%	22 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Denture Satisfaction
Description	Assessed by a questionnaire questionnaire based on the criteria used by Celebic and Knezovic-Zlataric (A comparison of patient's satisfaction between complete and partial removable denture wearers. J Dent. 2003;21:445-451) and used by Souza et al. (Validation of the Brazilian versions of two inventories for measuring oral health-related quality of life of edentulous subjects. Gerodontology. 2012;29:e88-95.). Eight questions were answered according to a three-point scale (0=unsatisfactory; 1=regular; 2=good), whose sum provided a summary satisfaction score that ranged from 0 (the participant is completely dissatisfied with existing dentures) to 16 (maximum satisfaction).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Convenience sampling.

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Canine guidance: Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Bilateral Balanced Occlusion: Complete dentures as conventionally adjusted, i.e. anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Median (Inter-Quartile Range) [units on a scale]	15	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	Statistical analysis was performed by a researcher who was unaware of all procedures performed. The questionnaire about denture satisfaction originated a general score that was compared using the Wilcoxon test, according to the two tested conditions.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.569
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Kinesiographic Parameters -- (1.a) Maximum Mouth Opening, Vertical Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	30.3 (4.5)	30.9 (4.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.339
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

3. Secondary Outcome

Title	Kinesiographic Parameters -- (1.b) Maximum Mouth Opening, Anteroposterior Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	25.1 (9.4)	25.8 (8.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.515
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

4. Secondary Outcome

Title	Kinesiographic Parameters -- (1.c) Maximum Mouth Opening, Left-right Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	1.4 (1.3)	1.7 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.485
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t test.

5. Secondary Outcome

Title	Kinesiographic Parameters -- (2.a) Rest Position, Vertical Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	2.1 (1.2)	2.3 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.111
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

6. Secondary Outcome

Title	Kinesiographic Parameters -- (2.b) Rest Position, Anteroposterior Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	1.9 (1.0)	1.9 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.399
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

7. Secondary Outcome

Title	Kinesiographic Parameters -- (2.c) Rest Position, Left-right Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	0.5 (0.5)	0.4 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.550
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

8. Secondary Outcome

Title	Kinesiographic Parameters -- (3.a) Mandibular Chewing Movement, Vertical Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	12.0 (2.7)	12.1 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.609
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

9. Secondary Outcome

Title	Kinesiographic Parameters -- (3.b) Mandibular Chewing Movement, Anteroposterior Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	4.2 (2.1)	4.3 (2.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.600
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

10. Secondary Outcome

Title	Kinesiographic Parameters -- (3.c) Mandibular Chewing Movement, Left-right Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	1.2 (2.1)	1.3 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.611
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

11. Secondary Outcome

Title	Kinesiographic Parameters -- (4.a) Upper Denture Base Movement, Vertical Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	-0.5 (0.4)	-0.6 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

12. Secondary Outcome

Title	Kinesiographic Parameters -- (4.b) Upper Denture Base Movement, Anteroposterior Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	-0.4 (0.7)	-0.4 (0.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.677
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

13. Secondary Outcome

Title	Kinesiographic Parameters -- (4.c) Upper Denture Base Movement, Left-right Axis
Description	Mandibular physiologic movements and the pattern of maxillary denture movement during chewing, as recorded by a kinesiograph (K6-I Diagnostic System, Myotronics research Inc., Seatle, WA). Specific measures involved: (1) Mouth opening; (2) Movement of the mandible from rest position to maximal occlusion (tooth clenching position); (3) Movement of the mandible during chewing; and (4) Movement of the upper denture base during chewing. Data from each measure was not combined into new variables, and collected in a single time point after each intervention. All measures were taken according to the vertical, anteroposterior and left-right axes separately.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Canine Guidance	Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)	Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
Measure Participants	39	39
Mean (Standard Deviation) [mm]	-0.1 (0.5)	-0.1 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Canine Guidance, Bilateral Balanced Occlusion
	Comments	For the kinesiographic assessment, the Kolmogorov-Smirnov test was used to evaluate whether the variables had normal distribution, which was positive in the majority of cases. A comparison between the values obtained for both groups was performed by means of the paired sample t-test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.885
	Comments	P values less than 0.05 would be considered statistically significant in this study.
	Method	t-test, 2 sided
	Comments	Paired t-test.

Adverse Events

Arm/Group Title	Canine Guidance		Bilateral Balanced Occlusion
Arm/Group Description	Complete dentures adjusted with "mutually protected articulation in which the vertical and horizontal overlap of the canine teeth disengage the posterior teeth in the excursive movements of the mandible" (The Glossary of Prosthodontic Terms. J. Prosthet. Dent., 94(1): 10-92)		Complete dentures as conventionally adjusted: anterior and posterior teeth presented bilateral contact in excentric positions
All Cause Mortality
	Canine Guidance		Bilateral Balanced Occlusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Canine Guidance		Bilateral Balanced Occlusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Canine Guidance		Bilateral Balanced Occlusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/41 (0%)

Limitations/Caveats

Losses during follow-up (although only 3 participants declined to continue the research - relatively small number); Possibility of errors in the kinesiographic assessment (low and equally distributed between the different conditions).

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.