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Intervention Study of Oral Health Education Programs Directed to Adolescents

Primary Purpose

Gingivitis, Periodontal Infection

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Patient centered oral health education
Standard educational intervention
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingivitis focused on measuring Gingivitis, Adolescents, Oral hygiene, Oral health behavior, Periodontal infection control

Eligibility Criteria

16 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kajsa H Abrahamsson

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient centered oral health education

Standard educational intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient reported outcome measures (PROM)
Questionnaire
Patient reported experience measures (PREM)
Questionnaire
Individual investment for treatment - Direct and subsidiary costs
Questionnaire - time, travel costs, costs for potential accompanying person

Full Information

First Posted
September 7, 2016
Last Updated
May 28, 2020
Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT02906098
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Vastra Gotaland Region

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Periodontal Infection
Keywords
Gingivitis, Adolescents, Oral hygiene, Oral health behavior, Periodontal infection control

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient centered oral health education
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard educational intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient centered oral health education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard educational intervention
Intervention Description
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 Outcome Measure Information:
Title
Marginal gingival bleeding index
Description
Percentage of tooth-surfaces with bleeding (infection) at clinical examination
Time Frame
Up to 18-months
Secondary Outcome Measure Information:
Title
Patient reported outcome measures (PROM)
Description
Questionnaire
Time Frame
Up to 18-months
Title
Patient reported experience measures (PREM)
Description
Questionnaire
Time Frame
Up to 18-months
Title
Individual investment for treatment - Direct and subsidiary costs
Description
Questionnaire - time, travel costs, costs for potential accompanying person
Time Frame
Up to 18-months
Other Pre-specified Outcome Measures:
Title
Plaque score
Description
Percentage of tooth-surfaces with dental plaque at clinical examination
Time Frame
Up to 18-months
Title
Treatment time for behavioral intervention in relation to total treatment time
Description
Questionnaire - assessment by caregiver regarding different treatment procedures
Time Frame
Up to 18-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kajsa H Abrahamsson, Odont Dr
Organizational Affiliation
Dept of periodontology, Inst of odontology, The Sahlgrenska academy, University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kajsa H Abrahamsson
City
Gothenburg
ZIP/Postal Code
SE 405 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35925040
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.
Results Reference
derived
PubMed Identifier
35132653
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.
Results Reference
derived

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Intervention Study of Oral Health Education Programs Directed to Adolescents

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