Bleeding on Probing, Gingival Index, Periodontal Diseases, Plaque Score
Conditions
Brief summary
The objective is a 3-year follow-up clinical trial to evaluate longitudinal indicators of periodontal disease (plaque score, bleeding on probing (BOP), and gingival index (GI)) in 58 participants who completed NCT03571958. These participants were randomized to a brief motivational (BMI) test group or a traditional oral hygiene instruction (OHI) group for a 1-year clinical trial from 2018-2020. In addition, analysis of retrospective data to determine health topics that emerge from the behavior change strategy of BMI compared to traditional OHI by transcription of audio recordings from 2018-2020.
Interventions
Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.
Sponsors
Study design
Eligibility
Inclusion criteria
° Completed all study visits of STUDY00003697 (NCT03571958)
Exclusion criteria
* Current smoker or quit smoking within the last year * Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported) * Uncontrolled diabetes (HbA1C \> 7) * Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS) * Current use of oral bisphosphonates * History of IV bisphosphonates * Require pre-medication or on long-term antibiotics * Current orthodontic treatment or planning to begin orthodontic treatment during the study * Unable to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque score | Recorded one time 2 years +/- 8 months | Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100% |
| Bleeding on probing | Recorded one time 2 years +/- 8 months | Presence of bleeding (yes) or absent of bleeding (no) |
| Gingival index | Recorded one time 2 years +/- 8 months | 0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding) |
Countries
United States