Status:
COMPLETED
Induced Gingivitis & Intra-oral Imaging
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Colgate Palmolive
Conditions:
Plaque Induced Gingivitis
Eligibility:
All Genders
18-35 years
Phase:
NA
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 gingivit...
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 co...
Eligibility Criteria
Inclusion
- 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
- • 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)
Key Trial Info
Start Date :
November 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2019
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03750955
Start Date
November 5 2018
End Date
June 3 2019
Last Update
March 9 2021
Active Locations (1)
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1
University of Washington School of Dentistry
Seattle, Washington, United States, 98195