Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up

Not Applicable

Completed

• Conditions: Periodontal Diseases; Plaque Score; Bleeding on Probing; Gingival Index
• Interventions: Other: BMI

• Registration Number: NCT05336396
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-20
• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-20
• Primary Completion: 2023-03-25
• Study Completion: 2023-03-25
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI	BMI	-

Primary Outcome Measures

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

School of Dentistry; 🇺🇸 Minneapolis, Minnesota, United States