Motivational Interview and Orthodontic Patients

NCT04871373 | Completed

• 1 other identifier: CEI2017-06
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

A parallel-group randomized clinical trial was conducted with 45 patients of the Orthodontic Clinic of Universidad Iberoamericana's (UNIBE) Postgraduate Unit. The study hypothesis was that motivational interview plus oral hygiene instructions would be more effective in maintaining long-term oral hygiene in comparison with conventional oral hygiene instructions alone. A computer-generated list of numbers created with Statistical Package for the Social Sciences (SPSS) V21.0 was used to random allocate participants into the experimental or the control group. Monthly oral hygiene instructions and a G.U.M. kit were given to the sample. Additionally, the experimental group received motivational interviewing sessions by a trained periodontist. Simplified Oral Hygiene Index, Gingival Index, Periodontal Probing Depth and Bleeding on Probing were recorded at baseline, three and six months after the beginning of the study. Repeated-measures analysis of variance and chi-squared test were conducted.

Conditions

Motivational Interviewing; Oral Hygiene; Orthodontic Appliance Complication

Keywords

Motivational interviewing; Oral hygiene; Fixed orthodontic appliances; Treatment adherence

Outcome Measures

Primary Outcomes (3)

• Simplified Oral Hygiene Index

  six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.

  Base line.

• Simplified Oral Hygiene Index

  six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.

  3rd month

• Simplified Oral Hygiene Index

  six surfaces (from fou r posterior and two anterior teeth ) are examined for debris and calculus, whereas 12 surfaces are examined.

  6th month

Secondary Outcomes (3)

• Gingival Index

  Base line, 3 and 6 months after the intervention.

• Periodontal Probing Depth

  Base line, 3 and 6 months after the intervention.

• Bleeding on Probing

  Base line, 3 and 6 months after the intervention.

Study Arms (2)

Experimental group

EXPERIMENTAL

A trained periodontist delivered oral hygiene instructions and motivational interviewing sessions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.

Behavioral: Motivational interviewing; Behavioral: Oral Hygiene Instructions

Control group

ACTIVE COMPARATOR

A trained periodontist delivered only oral hygiene instructions. All the participants received a G.U.M. kit with special orthodontic hygiene tools.

Behavioral: Oral Hygiene Instructions

Interventions

Motivational interviewing BEHAVIORAL

A periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group.

Also known as: Motivational interview

Experimental group

Oral Hygiene Instructions BEHAVIORAL

A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.

Also known as: OHI

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with 18-40 years old, systemically healthy, without active dental caries lesions or periodontal diseases, who were candidates for fixed orthodontic appliances.

You may not qualify if:

• Smokers and pregnant patients.
• Participants were discarded if they decided voluntarily to abandon the study of the orthodontic treatment or if they didn't attend to the periodical check-ups.

Sponsors & Collaborators

• Universidad Iberoamericana: lead
• Laboratorios Collado: collaborator

Study Sites (1)

Universidad Iberoamericana UNIBE

Santo Domingo, Nacional, 22333, Dominican Republic

Location

Related Publications (43)

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MeSH Terms

Conditions

Treatment Adherence and Compliance

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Henry A Adames, MsC

  Universidad Iberoamericana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Two dentists were in charge of the study logistic. They enrolled and allocated the participants according to the order of arrival and following the list of random numbers. A coding system was used as a concealment mechanism, which consisted of colored labels attached to the participants' file. This system was only known by the logistics managers and the interviewer (the periodontist who provided the OHI and the MI). Thus, the participant and the evaluator (the periodontist who recorded the data) were masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Orthodontic patients were recruited to be divided into a control group (that received oral hygiene instructions) and an experimental group (that received oral hygiene instructions and motivational interviewing sessions).

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 4, 2021
• Study Start: June 16, 2017
• Primary Completion: November 12, 2018
• Study Completion: November 12, 2018
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)