- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03571958
Brief Motivational Interviewing (BMI)
April 13, 2022 updated by: University of Minnesota
Impact of Brief Motivational Interviewing During Continuous Patient Care to Enhance Oral Hygiene
The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal.
An additional goal is to investigate chairside time of implementing BMI.
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 Locations
-
-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or Female
- ≥ 18 years old
- Periodontal maintenance phase (at least one year)
- Plaque score ≥30% (O'Leary plaque score)
- Minimum of two sites with BOP
- Willingness to fulfill all study requirements
- Patient of Record at the University of Minnesota School of Dentistry
Exclusion Criteria:
- Current smoker or quit smoking less than one 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Traditional OHI (Control)
Advice giving method of OHI known as "tell-show-do" to inform, demonstrate, and expect patient compliance.
|
|
|
Experimental: BMI (Test)
A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change.
BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.
|
A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change.
BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque score
Time Frame: Recorded four times over a one year time frame
|
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
|
Recorded four times over a one year time frame
|
|
Bleeding on probing (BOP)
Time Frame: Recorded four times over a one year time frame
|
Presence of bleeding (yes) or absent of bleeding (no)
|
Recorded four times over a one year time frame
|
|
Gingival Index
Time Frame: Recorded four times over a one year time frame
|
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
|
Recorded four times over a one year time frame
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical attachment level
Time Frame: Recorded four times over a one year time frame
|
Measured in millimeters
|
Recorded four times over a one year time frame
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle Arnett, MS, 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)
October 1, 2018
Primary Completion (Actual)
September 18, 2020
Study Completion (Actual)
October 1, 2020
Study Registration Dates
First Submitted
June 18, 2018
First Submitted That Met QC Criteria
June 18, 2018
First Posted (Actual)
June 28, 2018
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- DENT-2018-26921
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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.
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