Intervention Study of Oral Health Education Programs Directed to Adolescents

May 28, 2020 updated by: Göteborg University

A Randomized Clinical Field Study on Behavioral Interventions to Increase Adolescent's Motivation for Self Performed Periodontal Infection Control

This study evaluates behavioral interventions to increase adolescent's motivation for self performed periodontal infection control, by means of adequate oral hygiene. Study subjects will be allocated to test and control group where the test will be subjected to an individually tailored oral health education program, based on cognitive- behavioral theory and principles, and the control to standard educational intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prevalence of chronic periodontitis is about 40% among the Swedish adult population. The key-factor for the prevention of periodontal disease progression is the establishment of periodontal infection control, by means of adequate daily oral hygiene. Hence, a main task for dental professionals is to educate and motivate the patient to such beneficial behavior. A hypothesis for the current study is that patient centered health promotion programs based on cognitive behavioral theory and principles and with a directive communicative approach, i.e. motivational interviewing techniques, add positive and lasting effects to standard educational interventions on self-performed periodontal infection control.

This randomized clinical field study involves 30 professionals (dental hygienists) and about 350 adolescent patients at 16 dental clinics in the Västra Götaland Region, Sweden. The approach in the evaluation is on patient-centered outcomes and health economics.

Study Type

Interventional

Enrollment (Actual)

312

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

  • Sweden
      • Gothenburg, Sweden, SE 405 30
        • Kajsa H Abrahamsson

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

16 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16 or 17 years old at inclusion
  • poor oral hygiene conditions (dental plaque and/or marginal gingival bleeding at >50% of tooth surfaces) at the time of examination and thus considered to be at increased risk for oral/periodontal disease progression.

Exclusion Criteria:

  • compromised medical or mental conditions that may requiring special care.

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: Patient centered oral health education
The program is based on cognitive behavioral theory and principles. Hence, the intervention is adapted to each individual's problem, capacity and goals were the dental hygienist use motivational interviewing skills in communication and act as a guiding resource during the process of behavioral change. The program follows a specific structure including components such as formulation of personal goals, continuous self-monitoring by diary and planning of behavior. The initial intervention phase contain 3 treatment sessions (45-60 min each) during a period of 12 weeks (baseline, 2-3 weeks and 10-12 weeks). Follow up are performed at 6- and 18-months.
Behavioral: Patient centered oral health education
Procedure: The theory-based educational intervention follows a specific structure. The initial phase contain 3 treatment sessions (45-60 min each) during a period of 12 weeks (baseline, 2-3 weeks and 10-12 weeks). Follow up are performed at 6- and 18-months.
Active Comparator: Standard educational intervention
The subjects in the control group receive educational intervention by a dental hygienist in accordance with conventional routines (oral health information and oral hygiene instruction at one or several occasions). Follow up are performed at 6- and 18-months.
Behavioral: Standard educational intervention
Procedure: The initial phase contain educational intervention in accordance with conventional routines (oral health information and oral hygiene instruction at one or several occasions). Follow up are performed at 6- and 18-months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal gingival bleeding index
Time Frame: Up to 18-months
Percentage of tooth-surfaces with bleeding (infection) at clinical examination
Up to 18-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcome measures (PROM)
Time Frame: Up to 18-months
Questionnaire
Up to 18-months
Patient reported experience measures (PREM)
Time Frame: Up to 18-months
Questionnaire
Up to 18-months
Individual investment for treatment - Direct and subsidiary costs
Time Frame: Up to 18-months
Questionnaire - time, travel costs, costs for potential accompanying person
Up to 18-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque score
Time Frame: Up to 18-months
Percentage of tooth-surfaces with dental plaque at clinical examination
Up to 18-months
Treatment time for behavioral intervention in relation to total treatment time
Time Frame: Up to 18-months
Questionnaire - assessment by caregiver regarding different treatment procedures
Up to 18-months

Collaborators and Investigators

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

Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region

Investigators

  • Principal Investigator: Kajsa H Abrahamsson, Odont Dr, Dept of periodontology, Inst of odontology, The Sahlgrenska academy, University of Gothenburg

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 (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kajsaha

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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