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

Periodontal Diseases Clinical Trial

— BMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336396
• Other study ID #: DENT-2022-30805
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: March 25, 2023

Study information

• Verified date: June 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 25, 2023
• Est. primary completion date: March 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding on Probing
• Periodontal Diseases

Intervention

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

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
Primary	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
Primary	Bleeding on probing	Presence of bleeding (yes) or absent of bleeding (no)	Recorded one time 2 years +/- 8 months
Primary	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