Motivational Interviewing in Orthodontic Patients (MIOrtho)

April 30, 2018 updated by: Maria Montserrat Rigau Gay, University of Barcelona

Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients

The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Odontologic Universitat de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Orthodontic patients wearing fixed appliances, within the first six months of treatment
  • Eruption completed (except for the third molars) or late mixed dentition.
  • Caucasian

Exclusion Criteria:

  • Pregnancy
  • Periodontal disease
  • Systemic illness
  • Medical treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral hygiene counseling and motivational interviewing
This group will receive a session of oral hygiene counseling and a single session of motivational interviewing to increase the readiness of change.
Behavioral: Motivational interviewing
No Intervention: Oral hygiene counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess change in oral hygiene using plaque index Löe & Silness
Time Frame: Baseline, 1 month and 6 months
Plaque index Löe & Silness (Time: baseline, 1 month and 6 months)
Baseline, 1 month and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess change in oral hygiene using gingival index Löe & Silness
Time Frame: Baseline, 1 month and 6 months
Gingival index Löe & Silness ( Time: baseline, 1 month and 6 months)
Baseline, 1 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Principal Investigator: Maria Montserrat Rigau Gay, DDS, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

June 26, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MI01

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Informed Consent Form

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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