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

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 Overview

• Status: Completed
• Conditions: Periodontal Diseases; Gingival Index; Plaque Score; Bleeding on Probing
• Intervention / Treatment: Other: BMI

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • School of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMI	Other: BMI; Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.
No Intervention: Traditional Oral Hygiene Instruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque score	Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%	Recorded one time 2 years +/- 8 months
Bleeding on probing	Presence of bleeding (yes) or absent of bleeding (no)	Recorded one time 2 years +/- 8 months
Gingival index	0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)	Recorded one time 2 years +/- 8 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Michelle Arnett, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): March 25, 2023
• Study Completion (Actual): March 25, 2023

Study Registration Dates

• First Submitted: April 12, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases
• Other Study ID Numbers: DENT-2022-30805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No