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

June 29, 2023 updated by: Michelle Arnett, University of Minnesota

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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%
Recorded one time 2 years +/- 8 months
Bleeding on probing
Time Frame: Recorded one time 2 years +/- 8 months
Presence of bleeding (yes) or absent of bleeding (no)
Recorded one time 2 years +/- 8 months
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)
Recorded one time 2 years +/- 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Michelle Arnett, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontal Diseases

Clinical Trials on BMI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe