Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Gingival index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Gingival index
Time Frame: Recorded one time 2 years +/- 8 months
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Plaque score
Time Frame: 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
Time Frame: Recorded one time 2 years +/- 8 months
Presence of bleeding (yes) or absent of bleeding (no)
Secondary Outcomes
No secondary outcomes reported
Investigators
Michelle Arnett
Assistant Professor
University of Minnesota