Plaque Induced Gingivitis Clinical Trial
Official title:
Induced Gingivitis & Intra-oral Imaging
Verified date | March 2021 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 3, 2019 |
Est. primary completion date | June 3, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington School of Dentistry | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Colgate Palmolive |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. | 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 |
Baseline to Day 14 | |
Secondary | Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. | 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 |
Day 14 to Day 28 | |
Secondary | Change From Baseline Angiogenesis Chemokine Concentration at Day 28 | Assessment of the concentration of the angiogenesis chemokine angiopoietin-1 during experimental gingivitis. | Baseline to Day 28 |
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