Induced Gingivitis & Intra-oral Imaging

NCT03750955 | Completed Results FDA Device

• 1 other identifier: SITE00000993
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Induced Gingivitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index.

  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

  Baseline to Day 14

• Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index.

  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

  Day 14 to Day 28

Secondary Outcomes (3)

• Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index.

  Baseline to Day 14

• Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index.

  Day 14 to Day 28

• Change From Baseline Angiogenesis Chemokine Concentration at Day 28

  Baseline to Day 28

Study Arms (2)

Plaque induced gingivitis

EXPERIMENTAL

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

Oral hygiene maintenance

ACTIVE COMPARATOR

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

Interventions

Plaque induced gingivitis DEVICE

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.

Also known as: Cessation of oral hygiene

Plaque induced gingivitis

Oral hygiene maintenance DEVICE

Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.

Oral hygiene maintenance

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Colgate Palmolive: collaborator

Study Sites (1)

University of Washington School of Dentistry

Seattle, Washington, 98195, United States

Location

Results Point of Contact

• Title: Dr. Diane Daubert
• Organization: University of Washington

ddaubert@uw.edu

206-685-3766

Study Officials

• Richard P Darveau, MS, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Dentistry

Model Details: Split-mouth

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 23, 2018
• Study Start: November 5, 2018
• Primary Completion: June 3, 2019
• Study Completion: June 3, 2019
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-03

Locations

US (1)