A Randomized Clinical Field Study on Behavioral Interventions to Increase Adolescent's Motivation for Self Performed Periodontal Infection Control
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Marginal gingival bleeding index
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Patient centered oral health education (Behavioral)
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.
Intervention: Standard educational intervention (Behavioral)
Outcomes
Primary Outcomes
Marginal gingival bleeding index
Time Frame: Up to 18-months
Percentage of tooth-surfaces with bleeding (infection) at clinical examination
Secondary Outcomes
- Patient reported outcome measures (PROM)(Up to 18-months)
- Individual investment for treatment - Direct and subsidiary costs(Up to 18-months)
- Patient reported experience measures (PREM)(Up to 18-months)