Intervention Study of Oral Health Education Programs Directed to Adolescents

NCT02906098 | Completed

• 1 other identifier: kajsaha
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Periodontal Infection

Keywords

Gingivitis; Adolescents; Oral hygiene; Oral health behavior; Periodontal infection control

Outcome Measures

Primary Outcomes (1)

• Marginal gingival bleeding index

  Percentage of tooth-surfaces with bleeding (infection) at clinical examination

  Up to 18-months

Secondary Outcomes (3)

• Patient reported outcome measures (PROM)

  Up to 18-months

• Patient reported experience measures (PREM)

  Up to 18-months

• Individual investment for treatment - Direct and subsidiary costs

  Up to 18-months

Other Outcomes (2)

• Plaque score

  Up to 18-months

• Treatment time for behavioral intervention in relation to total treatment time

  Up to 18-months

Study Arms (2)

Patient centered oral health education

EXPERIMENTAL

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

Standard educational intervention

ACTIVE COMPARATOR

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

Interventions

Patient centered oral health education BEHAVIORAL

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.

Patient centered oral health education

Standard educational intervention BEHAVIORAL

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.

Standard educational intervention

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Kajsa H Abrahamsson

Gothenburg, SE 405 30, Sweden

Location

Related Publications (2)

• 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.

  PMID: 35925040 DERIVED

• 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.

  PMID: 35132653 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Kajsa H Abrahamsson, Odont Dr

  Dept of periodontology, Inst of odontology, The Sahlgrenska academy, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: September 19, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)