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

NCT ID: NCT05336396

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2023-03-25

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases Plaque Score Bleeding on Probing Gingival Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BMI

Group Type EXPERIMENTAL

BMI

Intervention Type OTHER

Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.

Traditional Oral Hygiene Instruction

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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BMI

Longitudinal data will be collected to determine the effectiveness of BMI compared to traditional OHI to maintain and improve periodontal health.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Michelle Arnett

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle Arnett

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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School of Dentistry

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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DENT-2022-30805

Identifier Type: -

Identifier Source: org_study_id

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