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

NCT05336396 | Completed

• 1 other identifier: DENT-2022-30805
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases; Plaque Score; Bleeding on Probing; Gingival Index

Outcome Measures

Primary Outcomes (3)

• Plaque score

  Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%

  Recorded one time 2 years +/- 8 months

• Bleeding on probing

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

  Recorded one time 2 years +/- 8 months

• Gingival index

  0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)

  Recorded one time 2 years +/- 8 months

Study Arms (2)

BMI

EXPERIMENTAL

Other: BMI

Traditional Oral Hygiene Instruction

NO INTERVENTION

Interventions

BMI OTHER

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

BMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ° Completed all study visits of STUDY00003697 (NCT03571958)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Michelle Arnett

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 20, 2022
• Study Start: May 20, 2019
• Primary Completion: March 25, 2023
• Study Completion: March 25, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)