An interventional study of Patient centered oral health education and Standard educational intervention in Gingivitis and Periodontal Infection, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to participants aged 16 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-06-01.
Sponsored by Göteborg University · Not applicable, Interventional, and Prevention
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 312 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
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
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 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.
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.
Marginal gingival bleeding index
Percentage of tooth-surfaces with bleeding (infection) at clinical examination
Time frame: Up to 18-months
Patient reported outcome measures (PROM)
Questionnaire
Time frame: Up to 18-months
Patient reported experience measures (PREM)
Questionnaire
Time frame: Up to 18-months
Individual investment for treatment - Direct and subsidiary costs
Questionnaire - time, travel costs, costs for potential accompanying person
Time frame: Up to 18-months
Plaque score
Percentage of tooth-surfaces with dental plaque at clinical examination
Time frame: Up to 18-months
Treatment time for behavioral intervention in relation to total treatment time
Questionnaire - assessment by caregiver regarding different treatment procedures
Time frame: Up to 18-months
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Göteborg University