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Completed

NCT Number: NCT05336396

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

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.

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Key information

Conditions

Periodontal Diseases Bleeding on Probing Gingival Index Mouth Diseases Plaque Score Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMI

Other

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

Primary outcomes

  1. Plaque score

    Time frame: Recorded one time 2 years +/- 8 months

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

  2. Bleeding on probing

    Time frame: Recorded one time 2 years +/- 8 months

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

  3. Gingival index

    Time frame: Recorded one time 2 years +/- 8 months

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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: BMI

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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