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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03571958
Other study ID # DENT-2018-26921
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2018
Est. completion date October 1, 2020

Study information

Verified date April 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date October 1, 2020
Est. primary completion date September 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Motivational Interviewing, BMI, OHI

Intervention

Behavioral:
BMI
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.

Locations

Country Name City State
United States School of Dentistry Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Clinical attachment level Measured in millimeters Recorded four times over a one year time frame
Primary Plaque score 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
Primary Bleeding on probing (BOP) Presence of bleeding (yes) or absent of bleeding (no) Recorded four times over a one year time frame
Primary Gingival Index 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