Intervention Study of Oral Health Education Programs Directed to Adolescents

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Gingivitis, Periodontal Infection

Intervention / Treatment
-----------------
* Behavioral: Patient centered oral health education
* Behavioral: Standard educational intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient centered oral health education<br>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<br>* 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.<br>|
| Active Comparator: Standard educational intervention<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gingivitis, Adolescents, Oral hygiene, Oral health behavior, Periodontal infection control