Intervention Study of Oral Health Education Programs Directed to Adolescents

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906098
• Other study ID #: kajsaha
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2020

Study information

• Verified date: May 2020
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis
• Infection
• Periodontal Infection
• Periodontitis

Intervention

Behavioral:
• Patient centered oral health education
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.
• Standard educational intervention
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.

Locations

Country	Name	City	State
Sweden	Kajsa H Abrahamsson	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plaque score	Percentage of tooth-surfaces with dental plaque at clinical examination	Up to 18-months
Other	Treatment time for behavioral intervention in relation to total treatment time	Questionnaire - assessment by caregiver regarding different treatment procedures	Up to 18-months
Primary	Marginal gingival bleeding index	Percentage of tooth-surfaces with bleeding (infection) at clinical examination	Up to 18-months
Secondary	Patient reported outcome measures (PROM)	Questionnaire	Up to 18-months
Secondary	Patient reported experience measures (PREM)	Questionnaire	Up to 18-months
Secondary	Individual investment for treatment - Direct and subsidiary costs	Questionnaire - time, travel costs, costs for potential accompanying person	Up to 18-months