NCT02829567

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

1.9 years

First QC Date

June 26, 2016

Last Update Submit

April 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess change in oral hygiene using plaque index Löe & Silness

    Plaque index Löe \& Silness (Time: baseline, 1 month and 6 months)

    Baseline, 1 month and 6 months

Secondary Outcomes (1)

  • Assess change in oral hygiene using gingival index Löe & Silness

    Baseline, 1 month and 6 months

Study Arms (2)

Oral hygiene counseling and motivational interviewing

EXPERIMENTAL

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

Oral hygiene counseling

NO INTERVENTION

Interventions

Oral hygiene counseling and motivational interviewing

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Periodontal disease
  • Systemic illness
  • Medical treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (2)

  • Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin Psychol Rev. 2009 Jun;29(4):283-93. doi: 10.1016/j.cpr.2009.02.001. Epub 2009 Feb 23.

    PMID: 19328605BACKGROUND
  • 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.

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Maria Montserrat Rigau Gay, DDS

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

June 26, 2016

First Posted

July 12, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

April 1, 2018

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations