NCT07164989

Brief Summary

This study is being conducted to explore how motivational interviewing (MI), A patient-centered counseling method, can help improve oral health awareness and practices in adolescents undergoing orthodontic treatment. Adolescents often struggle to maintain good oral hygiene during orthodontic care, which can lead to complications such as gum disease, tooth decay, and poor treatment outcomes. Participants in this study will receive brief, structured conversations focused on encouraging them to set goals and take responsibility for their oral health. These interviews are designed to be non-judgmental and supportive, helping the participants explore their own motivations for keeping their teeth and gums healthy during braces treatment. The study will take place at a pediatric dentistry clinic and will involve adolescents aged approximately 14 to 19 who are receiving orthodontic care. The goal is to assess whether this type of communication improves their oral hygiene behaviors and outcomes compared to standard oral health education. Findings from this research may help pediatric dentists and orthodontists improve how they engage adolescent patients in taking care of their oral health.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress70%
Oct 2025Jul 2026

First Submitted

Initial submission to the registry

August 19, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

February 3, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

August 19, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

Motivational InterviewOral HygieneFixed Orthodontic Treatment

Outcome Measures

Primary Outcomes (3)

  • Improvement in Oral Hygiene as Measured by change in Plaque Index (Silness and Löe, 1964)

    Description: Change in Plaque Index score from baseline to the 6-month follow-up. The Plaque Index is scored on a 0-3 scale, where 0 = no plaque, 1 = thin plaque detectable by probe or disclosing solution, 2 = moderate visible plaque, and 3 = abundant plaque. A decrease in score indicates improved oral hygiene. Time Frame: Up to 6 months per participant Unit of Measure: Mean Plaque Index score (0-3 scale)

    Up to 6 months per participant

  • Improvement in Oral Hygiene as Measured by change in Gingival Index (Silness and Löe, 1964)

    Description: Change in Gingival Index score from baseline to the 6-month follow-up. The Gingival Index is scored on a 0-3 scale, where 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, and 3 = severe inflammation. A decrease in score indicates improved gingival health. Time Frame: Up to 6 months per participant Unit of Measure: Mean Gingival Index score (0-3 scale)

    Up to 6 months per participant

  • Change in Decayed, Missing, and Filled Teeth Index (DMFT)

    Description: The DMFT Index (Decayed, Missing, and Filled Teeth) is a standardized WHO measure of lifetime dental caries experience in permanent dentition. Each participant's teeth will be examined, and the number of decayed (D), missing (M, due to caries), and filled (F) teeth will be recorded. The total DMFT score is the sum of these categories, ranging from 0 (no caries experience) to 28 (all permanent teeth affected). Lower scores represent better oral health. Changes in DMFT from baseline to the 6-month follow-up will be assessed to determine the effectiveness of motivational interviewing compared to standard oral hygiene education.

    Up to 6 months per participant

Secondary Outcomes (1)

  • Self-Reported Oral Hygiene Behavior Questionnaire Score

    Up to 6 months per participant

Study Arms (2)

Motivational Interviewing Group

EXPERIMENTAL

Motivational Interviewing (MI) will be conducted as the primary behavioral intervention in the study group. MI is a collaborative, patient-centered communication technique designed to enhance a patient's intrinsic motivation to adopt healthier behaviors. It involves five core processes: engaging, focusing, evoking, planning, and reviewing. These sessions aim to help patients identify their own goals and motivations related to oral hygiene and to foster a sense of autonomy and accountability. In this study, MI sessions will be delivered by a single trained dental professional who has previous formal training and experience conducting MI as part of earlier research. To maintain quality and consistency, a structured MI script and checklist based on established MI protocols will be used for each session. Sessions will take place at three different time points throughout the study period.

Behavioral: Motivational Interviewing-Based Counseling

Standard Oral Health Education Group

EXPERIMENTAL

Participants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI.

Behavioral: Standard Oral Health Education

Interventions

Motivational interviewing (MI) is a structured, patient-centered counseling technique that helps individuals explore and resolve ambivalence toward behavior change. In this study, MI sessions will be delivered by trained pediatric dental professionals during routine orthodontic visits. Each session will last approximately 10-15 minutes and will be guided by a standardized MI protocol, focusing on improving oral hygiene behavior and increasing personal motivation and responsibility for oral care among adolescent participants. Sessions will be conducted at multiple time points during the course of treatment.

Motivational Interviewing Group

Participants in this group will receive the conventional oral hygiene education typically provided in orthodontic clinics. This includes verbal instructions and printed educational materials on topics such as toothbrushing technique, flossing with braces, and the importance of maintaining oral hygiene during orthodontic treatment. Education will be delivered by pediatric dental staff during scheduled orthodontic appointments at the same time points as the intervention group (baseline, 1-month, and 6-month visits). No motivational interviewing techniques will be used. This approach reflects routine care and serves as the comparator for evaluating the added value of MI.

Standard Oral Health Education Group

Eligibility Criteria

Age14 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged 14-19 years
  • Currently undergoing fixed orthodontic treatment with active appliances in the mouth
  • Available for three study encounters over a 6-month period
  • Able to read, understand, and communicate in English without the use of a translator
  • Able to provide consent, and whose parent/guardian also agrees to provide consent

You may not qualify if:

  • Patients with systemic diseases or conditions that may impact oral health
  • Patients who are expected to complete orthodontic treatment or have appliances removed within 6 months
  • Individuals requiring interpreter services for participation
  • Individuals unable or unwilling to provide consent (or whose guardians cannot provide consent)
  • Currently enrolled in another behavioral or oral health intervention study.
  • Any condition deemed by the investigators to make the participant ineligible for safe and effective participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB School of Dentistry/ Department of Pediatric Dentistry

Birmingham, Alabama, 35233, United States

Location

Related Publications (2)

  • Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.

    PMID: 30198774BACKGROUND
  • Cascaes AM, Bielemann RM, Clark VL, Barros AJ. Effectiveness of motivational interviewing at improving oral health: a systematic review. Rev Saude Publica. 2014 Feb;48(1):142-53. doi: 10.1590/s0034-8910.2014048004616.

    PMID: 24789647BACKGROUND

Related Links

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Yu Yin Lin, DDS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomized into two parallel arms: one receiving motivational interviewing-based counseling sessions, and one receiving standard oral health education during orthodontic care. The intervention will occur during routine follow-up visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 19, 2025

First Posted

September 10, 2025

Study Start

October 28, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

February 3, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Because this study involves adolescent participants and collects identifiable behavioral and dental health data, individual participant data (IPD) will not be shared to protect participant confidentiality. However, aggregate results from the study will be published and shared through peer-reviewed journals and presentations.

Available IPD Datasets

"Educational resource supporting the study's behavioral intervention strategy using motivational interviewing in dental settings." (MI_Education_Link)Access

Locations