Clinical trial NCT02906098: Intervention Study of Oral Health Education Programs Directed to Adolescents
Official title: A Randomized Clinical Field Study on Behavioral Interventions to Increase Adolescent's Motivation for Self Performed Periodontal Infection Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Periodontal Infection
Keywords: Gingivitis
Adolescents
Oral hygiene
Oral health behavior
Periodontal infection control
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2016-09-19
Enrollment: 312
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Marginal gingival bleeding index
timeFrame: Up to 18-months
Secondary outcomes:
measure: Patient reported outcome measures (PROM)
timeFrame: Up to 18-months
measure: Patient reported experience measures (PREM)
timeFrame: Up to 18-months
measure: Individual investment for treatment - Direct and subsidiary costs
timeFrame: Up to 18-months
Other outcomes:
measure: Plaque score
timeFrame: Up to 18-months
measure: Treatment time for behavioral intervention in relation to total treatment time
timeFrame: Up to 18-months
Locations:
city: Gothenburg
country: Sweden
facility: Kajsa H Abrahamsson
Study officials:
affiliation: Dept of periodontology, Inst of odontology, The Sahlgrenska academy, University of Gothenburg
name: Kajsa H Abrahamsson, Odont Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dimenas SL, Ostberg AL, Lundin M, Lundgren J, Abrahamsson KH. Adolescents' experiences of a theory-based behavioural intervention for improved oral hygiene: A qualitative interview study. Int J Dent Hyg. 2022 Nov;20(4):609-619. doi: 10.1111/idh.12606. Epub 2022 Aug 15.
citation: Dimenas SL, Jonsson B, Andersson JS, Lundgren J, Petzold M, Abrahamsson I, Abrahamsson KH. A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study. J Clin Periodontol. 2022 Apr;49(4):378-387. doi: 10.1111/jcpe.13601. Epub 2022 Feb 23.