Induced Gingivitis & Intra-oral Imaging

NCT ID: NCT03750955

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-05
• Study Completion Date: 2019-06-03

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.

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).

Conditions

Plaque Induced Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Plaque induced gingivitis

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Oral hygiene maintenance

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Cessation of oral hygiene

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Richard Darveau

Professor, School of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard P Darveau, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington School of Dentistry

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SITE00000993

Identifier Type: -

Identifier Source: org_study_id