Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

• Sponsor: 3M (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01369108
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.

Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Device: Flowable composite; Device: Conventional composite restorative	N/A

Detailed Description

The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of a Low Shrinkage Flowable Resin Composite in Adult Teeth
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flowable composite Flowable composite	Device: Flowable composite; Restoration of small Class V and I cavities in molar and premolar teeth; Other Names: Filtek Supreme Ultra Flowable Restorative 3M ESPE)
Active Comparator: Conventional composite Highly filled conventional composite restorative	Device: Conventional composite restorative; Restoration of small Class V and I cavities in molar and premolar teeth

Outcome Measures

Primary Outcome Measures

1. Clinical Performance by Cvar & Ryge Scores [baseline, 6, 12 and 24 months]

   Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).

2. Clinical Performance by VAS (Pain Scale) [baseline, 6, 12 and 24 months]

   Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 19 years or older

• must give written consent

• be in good general health

• be available for required follow-up visits

• have at least 28 teeth

Exclusion Criteria:

• has rampant, uncontrolled caries

• has advanced, untreated periodontal disease

• heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco

• has systemic or local disorders that contra-indicate the dental procedures needed in this study

• has evidence of xerostomia

• has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy

• is pregnant at time of screening or tooth restoration

• has known sensitivity to acrylates or related materials

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham School of Dentistry, 605 School of Dentistry Building, 1919 7th Avenue South	Birmingham	Alabama	United States	35233-2005

Sponsors and Collaborators

• 3M

Investigators

• Principal Investigator: John O Burgess, DDS, MS, Unversity of Alabama at Birmingam Dental School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT01369108
• Other Study ID Numbers: CR-10-013
• First Posted: Jun 8, 2011
• Last Update Posted: Nov 9, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by 3M: small Class I; molar and premolar; low stress flowable composite; adult; Restoration; small caries lesions
• Additional relevant MeSH terms: Dental Caries

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Period Title: Overall Study
STARTED	60
COMPLETED	49
NOT COMPLETED	11

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Overall Participants	60
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	60 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	52
Sex: Female, Male (Count of Participants)
Female	43 71.7%
Male	17 28.3%
Region of Enrollment (participants) [Number]
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Performance by Cvar & Ryge Scores
Description	Clinical performance reported on 6 parameters as the % of teeth with perfect scores ("A" rating). Cvar & Ryge scores measure 6 parameters: Anatomic form (rated A,B= satisfactory, C=unsatisfactory); Color Match (A=match, B=mismatch, but within normal, C=mismatch outside normal); Marginal Adaptation (A=no visible crevice, B=no exposure of dentin, C=defect to enamel-dentine junction, D= fracture, missing); Marginal Discoloration (A=none, B= marginal discoloration, C=marginal discoloration to pulpal direction); Surface Integrity (A=smooth, B=slight rough, C=Pitted, D=fracture)'Secondary caries (A=none, D=present).
Time Frame	baseline, 6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Flowable Composite	Conventional Composite
Arm/Group Description	Flowable composite Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth	Highly filled conventional composite restorative Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Measure Participants	49	49
Measure teeth	49	49
Color match baseline	96.6	88.3
Anatomic baseline	100.0	100.0
Marginal adaptation baseline	96.6	98.3
Marginal discoloration Baseline	98.3	98.3
Surface Integrity Baseline	98.3	96.7
Secondar carries Baseline	100.	98.3
Anatomic form 6 Mo	100.	98.3
Color match form 6 Mo	96.6	91.7
Marginal adaptation 6 Mo	93.2	88.3
Marginal discoloration 6 Mo	96.6	95.0
Surface integrity 6 Mo	96.6	90.0
Secondary caries 6 Mo	100.	96.7
Anatomic form 12 Mo	96.4	94.6
Color match 12 Mo	92.7	83.9
Marginal adaption 12 Mo	81.8	78.6
Marginal discoloration 12 Mo	90.9	90.1
Surface Integrity 12 Mo	92.7	78.6
Secondary caries 12 Mo	94.5	94.6
Anatomic form 24 Mo	89.8	86.0
Color match 24 Mo	85.7	78.0
Marginal adaption 24 Mo	83.7	80.0
Marginal discoloraton 24 Mo	85.7	80.0
Surface integrity 24 Mo	79.6	78.0
Secondary caries 24 Mo	93.9	94

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in anatomic form
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in margin adaptation
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.89
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in margin discoloration
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.79
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in surface integrity
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.18
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in secondary caries
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.66
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Clinical Performance by VAS (Pain Scale)
Description	Sensitivity to cold was measured by applying a cotton pellet soaked with pulp vitality refrigerant spray (Endo Ice, Coltene/ Whaledent, Cuyahoga Falls, OH, USA) to the tooth for three seconds. Sensitivity to biting was measured by having the patient bite on a cotton roll for five seconds. After each test, the subject was asked to place an ''X'' on a 10-mm line labeled ''1'' on the left and ''10'' on the right. Patients were told that a ''10'' represents the worst pain they can imagine (ie, childbirth, major surgery, or kidney stone) and that ''1'' represents no sensation at all.
Time Frame	baseline, 6, 12 and 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Flowable Composite	Conventional Composite
Arm/Group Description	Flowable composite Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth	Highly filled conventional composite restorative Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
Measure Participants	49	49
Measure teeth	49	49
sensitiity to cold baseline	1.6 (1.6)	1.6 (2.0)
sensitivity to biting baseline	0.5 (0.6)	0.7 (0.7)
sensitiity to cold 6 Mo	1.5 (1.4)	1.8 (1.7)
sensitiity to biting 6 Mo	0.6 (0.7)	0.8 (0.8)
sensitiity to cold 12 Mo	2.1 (2.2)	1.7 (1.7)
sensitiity to biting 12 Mo	0.3 (0.5)	0.3 (0.5)
sensitiity to cold 24 Mo	1.5 (1.9)	1.0 (1.3)
sensitiity to biting 24 Mo	0.2 (0.5)	0.1 (0.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in sensitivity to cold
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.522
	Comments
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Flowable Composite, Conventional Composite
	Comments	null hypothesis no difference in biting pressure
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.449
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	All Participants
Arm/Group Description	Each enrolled patient possessed two teeth that met the inclusion criteria. Of these, 120 teeth, 60 were allocated to the comparator group (Filtek Supreme Ultra Universal restorative) and 60 were allocated to the experimental group (Filtek Supreme Ultra Flowable. Flowable composite: Restoration of small Class V and I cavities in molar and premolar teeth Conventional composite restorative: Restoration of small Class V and I cavities in molar and premolar teeth
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/60 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/60 (0%)

Limitations/Caveats

[Not Specified]

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.