Trial Outcomes & Findings for Induced Gingivitis & Intra-oral Imaging (NCT NCT03750955)

Last Updated: 2021-03-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline to Day 14

Results posted on

2021-03-09

Participant Flow

Unit of analysis: L(left) or R(right) maxillary sextant

Participant milestones

Participant milestones
Measure	Plaque Induced Gingivitis 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 Maintenance 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.
Hygiene Phase of 2 Weeks STARTED	16 16	16 16
Hygiene Phase of 2 Weeks COMPLETED	13 13	13 13
Hygiene Phase of 2 Weeks NOT COMPLETED	3 3	3 3
Gingivitis Induction Phase of 2 Weeks STARTED	13 13	13 13
Gingivitis Induction Phase of 2 Weeks COMPLETED	13 13	13 13
Gingivitis Induction Phase of 2 Weeks NOT COMPLETED	0 0	0 0
Resolution Phase of 2 Weeks STARTED	13 13	13 13
Resolution Phase of 2 Weeks COMPLETED	13 13	13 13
Resolution Phase of 2 Weeks NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Plaque Induced Gingivitis 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 Maintenance 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.
Hygiene Phase of 2 Weeks Withdrawal by Subject	2	2
Hygiene Phase of 2 Weeks Not eligible at Baseline (start of gingivitis induction phase)	1	1

Baseline Characteristics

Induced Gingivitis & Intra-oral Imaging

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to Day 14

Outcome measures

Outcome measures
Measure	Plaque Induced Gingivitis n=13 Participants 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.	Oral Hygiene Maintenance n=13 Participants 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.
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.	0.6 units on a scale Standard Deviation 1.2	0.15 units on a scale Standard Deviation 0.3

PRIMARY outcome

Timeframe: Day 14 to Day 28

Outcome measures

Outcome measures
Measure	Plaque Induced Gingivitis n=13 Participants 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.	Oral Hygiene Maintenance n=13 Participants 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.
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.	0.08 units on a scale Standard Deviation 0.4	0.08 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Plaque Induced Gingivitis n=13 Participants 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.	Oral Hygiene Maintenance n=13 Participants 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.
Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.	0.84 units on a scale Standard Deviation 1.4	0.17 units on a scale Standard Deviation 0.24

SECONDARY outcome

Timeframe: Day 14 to Day 28

Outcome measures

Outcome measures
Measure	Plaque Induced Gingivitis n=13 Participants 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.	Oral Hygiene Maintenance n=13 Participants 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.
Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.	0.11 units on a scale Standard Deviation 0.18	0.105 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline to Day 28

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

Outcome measures

Outcome measures
Measure	Plaque Induced Gingivitis n=13 Participants 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.	Oral Hygiene Maintenance n=13 Participants 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.
Change From Baseline Angiogenesis Chemokine Concentration at Day 28	137825.56 picograms/milliliter Standard Deviation 339893.64	164411.80 picograms/milliliter Standard Deviation 408590.49

Adverse Events

Plaque Induced Gingivitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Hygiene Maintenance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hygiene Phase

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Systemic Adverse Events

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Plaque Induced Gingivitis n=13 participants at risk 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.	Oral Hygiene Maintenance n=13 participants at risk Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene (tooth brushing with fluoride toothpaste and flossing twice daily) is maintained.	Hygiene Phase n=13 participants at risk 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).	Systemic Adverse Events n=13 participants at risk 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.
Injury, poisoning and procedural complications tender maxillary left posterior buccal gingiva	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Injury, poisoning and procedural complications bruised achilles tendon	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Gastrointestinal disorders abraded palatal tissue left posterior	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Infections and infestations rhinorrhea	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Reproductive system and breast disorders menstrual cramps	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Infections and infestations cold	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.
Injury, poisoning and procedural complications ulcerated interdental papilla #14/15	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	7.7% 1/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.	0.00% 0/13 • 6 weeks Participants were questioned at each visit about adverse events since the previous visit.

Additional Information

Dr. Diane Daubert

University of Washington

Phone: 206-685-3766

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Plaque Induced Gingivitis n=13 L(left) and R(right) Maxillary sextant 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 Maintenance n=13 L(left) and R(right) Maxillary sextant 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 n=26 L(left) and R(right) Maxillary sextant Total of all reporting groups
Age, Continuous	23.3 years n=5 Participants	23.3 years n=7 Participants	23.3 years n=5 Participants
Sex/Gender, Customized Female	7 participants n=5 Participants	7 participants n=7 Participants	7 participants n=5 Participants
Sex/Gender, Customized Male	6 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native, Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native, Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian, Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian, Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander, Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander, Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White, Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White, Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized More than one race, Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized More than one race, Not Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported, Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported, Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Gingival Index	0.085 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants	0.055 units on a scale STANDARD_DEVIATION 0.3 • n=7 Participants	0.077 units on a scale STANDARD_DEVIATION 0.12 • n=5 Participants
Visible Plaque Index	0.078 units on a scale STANDARD_DEVIATION 0.3 • n=5 Participants	0.05 units on a scale STANDARD_DEVIATION 0.2 • n=7 Participants	0.067 units on a scale STANDARD_DEVIATION 0.12 • n=5 Participants
Angiogenesis chemokine - angiopoietin-1	141213.37 picograms/milliliter STANDARD_DEVIATION 338487.23 • n=5 Participants	165053.91 picograms/milliliter STANDARD_DEVIATION 408314.93 • n=7 Participants	153133.62 picograms/milliliter STANDARD_DEVIATION 367653.68 • n=5 Participants