Induced Gingivitis & Intra-oral Imaging

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03750955
• Collaborator: Colgate Palmolive (Industry)
• Enrollment: 16
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

Using an experimental, non-invasive intra-oral imaging device, this study evaluates the effects on the gingival tissue when oral hygiene is stopped in a section of the mouth for two weeks and gingivitis develops. The effects on the gingival tissue continues to be evaluated as oral hygiene is resumed and the gingival tissue returns to health.

Condition or Disease	Intervention/Treatment	Phase
Plaque Induced Gingivitis	Device: Plaque induced gingivitis; Device: Oral hygiene maintenance	N/A

Detailed Description

The study will include the following phases - 1) Hygiene phase of 2 weeks; 2) Gingivitis induction phase with stent lasting up to 2 weeks; and 3) Resolution phase of 2 weeks.

The intervention will consist of cessation of oral hygiene versus an active control of oral hygiene with a fluoridated toothpaste. This study is a modification of classical experimental gingivitis model. The study will prospectively enroll subjects and assign a maxillary sextant to the intervention, while the other sextant will serve as control in a split-mouth design of localized experimental gingivitis, utilizing localized stent-induced biofilm overgrowth model (SIBO). The intervention, i.e. oral hygiene cessation will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues. The purpose of this study is to evaluate the effects of oral hygiene cessation in the gingival tissues by an innovative non-invasive microimaging technique, i.e. Optical coherence tomography (OCT).

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Split-mouthSplit-mouth
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Induced Gingivitis & Intra-oral Imaging
• Actual Study Start Date: Nov 5, 2018
• Actual Primary Completion Date: Jun 3, 2019
• Actual Study Completion Date: Jun 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plaque induced gingivitis Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.	Device: Plaque induced gingivitis; Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.; Other Names: Cessation of oral hygiene
Active Comparator: Oral hygiene maintenance Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.	Device: Oral hygiene maintenance; Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. [Baseline to Day 14]

   The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation

2. Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. [Day 14 to Day 28]

   The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation

Secondary Outcome Measures

1. Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. [Baseline to Day 14]

   The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque

2. Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. [Day 14 to Day 28]

   The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque

3. Change From Baseline Angiogenesis Chemokine Concentration at Day 28 [Baseline to Day 28]

   Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• In good general health, ASA I

• No clinical signs of gingival inflammation at >90% sites observed

• Probing Depth(PD) ≤ 3.0 mm

• Attachment Loss (AL) = 0 mm

• Gingival health at baseline visit (Day 0): Gingival Index (GI) ≤ 0.5, Bleeding on probing (BOP)(-)

• Fluent in English

Exclusion Criteria:

• • Medical condition which requires premedication prior to dental treatments/visits

• Subjects unable or unwilling to undergo informed consent process.

• Subjects currently using anti-gingivitis oral rinses (washout period of 1 week)

• History of periodontal disease

• History of systemic inflammatory or immune conditions

• Use of antibiotic or anti-inflammatory drugs within 30 days of enrollment

• Pregnant or breastfeeding at time of screening

• Concurrent orthodontic treatment

• Untreated carious lesions and/or inadequate restorations, implants, crowns on maxillary non-molar teeth

• Participation in any other clinical study or test panel within 1 week prior to enrollment into this study

• Use of tobacco products

• Subjects who must receive dental treatment during the study dates

• Orthodontic bands, appliances, or crowns and bridges, or removable partial dentures affecting the non-molar maxillary teeth

• Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington School of Dentistry	Seattle	Washington	United States	98195

Sponsors and Collaborators

• University of Washington
• Colgate Palmolive

Investigators

• Principal Investigator: Richard P Darveau, MS, PhD, University of Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 18, 2018

More Information

Publications

None provided.

• Responsible Party: Richard Darveau, Professor, School of Dentistry, University of Washington
• ClinicalTrials.gov Identifier: NCT03750955
• Other Study ID Numbers: SITE00000993
• First Posted: Nov 23, 2018
• Last Update Posted: Mar 9, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Gingivitis

Study Results

Participant Flow

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Plaque induced gingivitis resulting from a cessation of oral hygiene in maxillary sextant right (teeth #5 to #8) or left (#9 to #12) using a stent-induced biofilm overgrowth (SIBO) model.	Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.
Period Title: Hygiene Phase of 2 Weeks
STARTED	16	16
COMPLETED	13	13
NOT COMPLETED	3	3
Period Title: Hygiene Phase of 2 Weeks
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0
Period Title: Hygiene Phase of 2 Weeks
STARTED	13	13
COMPLETED	13	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance	Total
Arm/Group Description	Plaque induced gingivitis resulting from a cessation of oral hygiene in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant using a stent-induced biofilm overgrowth model.	Oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained in a maxillary right (teeth #5 to #8) or left (#9 to #12) sextant.	Total of all reporting groups
Overall Participants	13	13	13
Overall L(left) and R(right) Maxillary sextant	13	13	26
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	23.3	23.3	23.3
Sex/Gender, Customized (participants) [Number]
Female	7 53.8%	7 53.8%	7 53.8%
Male	6 46.2%	6 46.2%	6 46.2%
Race/Ethnicity, Customized (Number) [Number]
American Indian or Alaska Native, Hispanic or Latino	0 0%	0 0%	0 0%
American Indian or Alaska Native, Not Hispanic or Latino	0 0%	0 0%	0 0%
Asian, Hispanic or Latino	0 0%	0 0%	0 0%
Asian, Not Hispanic or Latino	8 61.5%	8 61.5%	8 61.5%
Native Hawaiian or Other Pacific Islander, Hispanic or Latino	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander, Not Hispanic or Latino	0 0%	0 0%	0 0%
Black or African American, Hispanic or Latino	0 0%	0 0%	0 0%
Black or African American, Not Hispanic or Latino	0 0%	0 0%	0 0%
White, Hispanic or Latino	1 7.7%	1 7.7%	1 7.7%
White, Not Hispanic or Latino	1 7.7%	1 7.7%	1 7.7%
More than one race, Hispanic or Latino	0 0%	0 0%	0 0%
More than one race, Not Hispanic or Latino	2 15.4%	2 15.4%	2 15.4%
Unknown or Not Reported, Hispanic or Latino	1 7.7%	1 7.7%	1 7.7%
Unknown or Not Reported, Not Hispanic or Latino	0 0%	0 0%	0 0%
Gingival Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.085 (0.3)	0.055 (0.3)	0.077 (0.12)
Visible Plaque Index (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	0.078 (0.3)	0.05 (0.2)	0.067 (0.12)
Angiogenesis chemokine - angiopoietin-1 (picograms/milliliter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [picograms/milliliter]	141213.37 (338487.23)	165053.91 (408314.93)	153133.62 (367653.68)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.
Description	The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
Time Frame	Baseline to Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.	Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Measure Participants	13	13
Mean (Standard Deviation) [units on a scale]	0.6 (1.2)	0.15 (0.3)

2. Primary Outcome

Title	Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.
Description	The predictive validity of a non-invasive microimaging technique for assessing experimental gingivitis (plaque induced), as compared with gingival index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The gingival index is reported. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation
Time Frame	Day 14 to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.	Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Measure Participants	13	13
Mean (Standard Deviation) [units on a scale]	0.08 (0.4)	0.08 (0.2)

3. Secondary Outcome

Title	Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.
Description	The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
Time Frame	Baseline to Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.	Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Measure Participants	13	13
Mean (Standard Deviation) [units on a scale]	0.84 (1.4)	0.17 (0.24)

4. Secondary Outcome

Title	Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.
Description	The predictive validity of a microimaging technique for assessing experimental gingivitis, as compared with plaque index is not reported. The microimaging technique was used to measure changes in the gingival thickness of the inter-dental tooth area. This area measured did not represent the clinical status of the tissue surrounding the tooth. The plaque index is reported. Visible Plaque Index; scoring: 0 = no plaque; 1 = visible plaque
Time Frame	Day 14 to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.	Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Measure Participants	13	13
Mean (Standard Deviation) [units on a scale]	0.11 (0.18)	0.105 (0.5)

5. Secondary Outcome

Title	Change From Baseline Angiogenesis Chemokine Concentration at Day 28
Description	Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis.
Time Frame	Baseline to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Plaque Induced Gingivitis	Oral Hygiene Maintenance
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model. Plaque induced gingivitis: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.	Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained. Oral hygiene maintenance: Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
Measure Participants	13	13
Mean (Standard Deviation) [picograms/milliliter]	137825.56 (339893.64)	164411.80 (408590.49)

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	Participants were questioned at each visit about adverse events since the previous visit.
Arm/Group Title	Plaque Induced Gingivitis		Oral Hygiene Maintenance		Hygiene Phase		Systemic Adverse Events
Arm/Group Description	Non-invasive microimaging (OTC device) of gingival tissue where plaque induced gingivitis results from a cessation of oral hygiene in a sextant using a stent-induced biofilm overgrowth model.		Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.		Adverse Events that occurred during the Hygiene Phase of 2 weeks (the period between enrollment and the start of the Gingivitis Induction Phase of 2 weeks).		Adverse Events that occurred during the Gingivitis Induction Phase of 2 weeks and the Resolution Phase 2 weeks but are not specifically attributable to either the Plaque Induced Gingivitis intervention or the Oral Hygiene Maintenance intervention as the two interventions occurred simultaneously in each participant.
All Cause Mortality
	Plaque Induced Gingivitis		Oral Hygiene Maintenance		Hygiene Phase		Systemic Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)		0/13 (0%)
Serious Adverse Events
	Plaque Induced Gingivitis		Oral Hygiene Maintenance		Hygiene Phase		Systemic Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		0/13 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Plaque Induced Gingivitis		Oral Hygiene Maintenance		Hygiene Phase		Systemic Adverse Events
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/13 (0%)		4/13 (30.8%)		3/13 (23.1%)
Gastrointestinal disorders
abraded palatal tissue left posterior	0/13 (0%)		0/13 (0%)		0/13 (0%)		1/13 (7.7%)
Infections and infestations
rhinorrhea	0/13 (0%)		0/13 (0%)		1/13 (7.7%)		0/13 (0%)
cold	0/13 (0%)		0/13 (0%)		0/13 (0%)		1/13 (7.7%)
Injury, poisoning and procedural complications
ulcerated interdental papilla #14/15	0/13 (0%)		0/13 (0%)		1/13 (7.7%)		0/13 (0%)
bruised achilles tendon	0/13 (0%)		0/13 (0%)		0/13 (0%)		1/13 (7.7%)
tender maxillary left posterior buccal gingiva	0/13 (0%)		0/13 (0%)		1/13 (7.7%)		0/13 (0%)
Reproductive system and breast disorders
menstrual cramps	0/13 (0%)		0/13 (0%)		1/13 (7.7%)		0/13 (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.