NCT03571958

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

June 18, 2018

Last Update Submit

April 13, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • Bleeding on probing (BOP)

    Presence of bleeding (yes) or absent of bleeding (no)

    Recorded four times over a one year time frame

  • 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

Other Outcomes (1)

  • Clinical attachment level

    Recorded four times over a one year time frame

Study Arms (2)

Traditional OHI (Control)

NO INTERVENTION

Advice giving method of OHI known as "tell-show-do" to inform, demonstrate, and expect patient compliance.

BMI (Test)

EXPERIMENTAL

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.

Behavioral: BMI

Interventions

BMIBEHAVIORAL

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.

BMI (Test)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Michelle Arnett, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2018

First Posted

June 28, 2018

Study Start

October 1, 2018

Primary Completion

September 18, 2020

Study Completion

October 1, 2020

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations