N/A
N=32
Induced Gingivitis & Intra-oral Imaging
Plaque Induced Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT03750955 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. — 0.6; 0.15 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Plaque induced gingivitis (Device); Oral hygiene maintenance (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Gingival Index. |
0.6; 0.15 | — |
| PRIMARY Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Gingival Index. |
0.08; 0.08 | — |
| SECONDARY Change From Baseline Gingivitis at Day 14 as Measured by Non-invasive Microimaging and Plaque Index. |
0.84; 0.17 | — |
| SECONDARY Change From Day 14 Gingivitis at Day 28 as Measured by Non-invasive Microimaging and Plaque Index. |
0.11; 0.105 | — |
| SECONDARY Change From Baseline Angiogenesis Chemokine Concentration at Day 28 |
137825.56; 164411.80 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT03750955). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.