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Completed

NCT Number: NCT02906098

Intervention Study of Oral Health Education Programs Directed to Adolescents

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.

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Periodontal Infection Stomatognathic Diseases

Age range

16 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kajsa H Abrahamsson

Gothenburg, SE 405 30, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Marginal gingival bleeding index

    Time frame: Up to 18-months

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

Secondary outcomes

  1. Patient reported outcome measures (PROM)

    Time frame: Up to 18-months

    Questionnaire

  2. Patient reported experience measures (PREM)

    Time frame: Up to 18-months

    Questionnaire

  3. Individual investment for treatment - Direct and subsidiary costs

    Time frame: Up to 18-months

    Questionnaire - time, travel costs, costs for potential accompanying person

Other outcomes

  1. Plaque score

    Time frame: Up to 18-months

    Percentage of tooth-surfaces with dental plaque at clinical examination

  2. Treatment time for behavioral intervention in relation to total treatment time

    Time frame: Up to 18-months

    Questionnaire - assessment by caregiver regarding different treatment procedures

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2016
Registry last updated
Jun 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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