Back to resultsImpact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up (BMI)
Primary Purpose
Periodontal Diseases, Plaque Score, Bleeding on Probing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BMI
Sponsored by
About this trial
This is an interventional basic science trial for Periodontal Diseases
Eligibility Criteria
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
Sites / Locations
- School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BMI
Traditional Oral Hygiene Instruction
Arm Description
Outcomes
Primary Outcome Measures
Plaque score
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
Bleeding on probing
Presence of bleeding (yes) or absent of bleeding (no)
Gingival index
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05336396
Brief Title
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
Acronym
BMI
Official Title
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
March 25, 2023 (Actual)
Study Completion Date
March 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Plaque Score, Bleeding on Probing, Gingival Index
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMI
Arm Type
Experimental
Arm Title
Traditional Oral Hygiene Instruction
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
BMI
Intervention Description
Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.
Primary Outcome Measure Information:
Title
Plaque score
Description
Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%
Time Frame
Recorded one time 2 years +/- 8 months
Title
Bleeding on probing
Description
Presence of bleeding (yes) or absent of bleeding (no)
Time Frame
Recorded one time 2 years +/- 8 months
Title
Gingival index
Description
0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)
Time Frame
Recorded one time 2 years +/- 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Arnett
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dentistry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Brief Motivational Interviewing on Periodontal Clinical Outcomes: a 3-year Post-trial Follow-up
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