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Oral Health Literacy Tailored Communication

Primary Purpose

Periodontal Diseases, Dental Plaque, Dental Calculus

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Tailored oral health literacy instruction
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Periodontal Diseases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants > 20 years of age.
  • Participants who master the Norwegian language.
  • Participants who are registered at the university dental clinic (IKO).

Exclusion Criteria:

  • People who do not master the Norwegian language.
  • Strongly visually impaired people that have difficulty in reading.
  • People with a history of heart-attack in the past 6 months.
  • Immune- compromised people and organ- transplanted people.
  • People with other conditions that might lead to more disadvantages than advantages by participating

Sites / Locations

  • Institute of Clinical Dentistry, University of Tromsø
  • Public Dental Service Competence Centre of Northern Norway (TkNN)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

Tailored oral health literacy instruction

Oral health instruction not tailored to oral health literacy level

Outcomes

Primary Outcome Measures

Gingival Index
The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.

Secondary Outcome Measures

Plaque Index
The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque. The Plaque index reference is Silness and Löe, 1964.

Full Information

First Posted
April 28, 2010
Last Updated
March 26, 2015
Sponsor
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT01118143
Brief Title
Oral Health Literacy Tailored Communication
Official Title
Effects of Communication Tailored to Oral Health Literacy Level of Adult Dental Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study to investigate attitude, oral health literacy and psychological factors in order to evaluate if these factors are important for oral health in adults. The hypotheses are: Multiple interactive demographic, and social and psychological factors contribute to the level of attitude and oral health literacy. There is an association between the level of oral health literacy and oral health status A structured intervention based on oral health literacy can change the attitude and improve the oral health status. Background knowledge has influence on attitude and oral health literacy Individuals with positive attitude towards dental health and dentist are attentive towards their oral health.
Detailed Description
This study will be conducted in two stages. The first stage includes a baseline cross-sectional investigation. Oral health literacy level will be assessed by conducting a structured interview. Background variables, attitude, socioeconomic factors and psychological factors shall be assessed using self-administered questionnaires. A clinical examination will be conducted including general health information and extended oral health examination. The oral health examination performed includes record of oral hygiene status such as dental caries and periodontal status. An assessment of oral bacteria will also be performed. The second stage will be carried out approximately 6 months after starting with the baseline investigation. At that time a modified version of the questionnaires will be used followed by a shorter clinical examination. The modified questionnaires at the second data collection exclude some background variables. The clinical examination carried out during this time will be on dental plaque and bleeding index and the level of oral bacteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Dental Plaque, Dental Calculus, Sialorrhea, Streptococcal Infections, Lactobacillus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Tailored oral health literacy instruction
Arm Title
control group
Arm Type
No Intervention
Arm Description
Oral health instruction not tailored to oral health literacy level
Intervention Type
Behavioral
Intervention Name(s)
Tailored oral health literacy instruction
Other Intervention Name(s)
Lifestyle counseling
Intervention Description
The intervention includes oral hygiene instruction tailored to the level of oral health literacy, and will include information about the outcome of the clinical examination. Providing relevant information to the participant will be in focus, and there will be given a personalized demonstration as well as guidance on how to conduct proper oral hygiene practices at home. The aim of the intervention is to improve oral hygiene and attitudes towards dental care by taking the literacy level of the participant into consideration.
Primary Outcome Measure Information:
Title
Gingival Index
Description
The gingival index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = mild inflammation; 1.1-2.0 = moderate inflammation; 2.1-3.0 = severe inflammation. The GI reference is Löe and Silness, 1963.
Time Frame
6 months after intervention
Secondary Outcome Measure Information:
Title
Plaque Index
Description
The plaque index of the individual was obtained by adding the values of each tooth (an average of 4 scores) and dividing by number of teeth examined with the resulting scores as follows 0.1-1.0 = low accumulation of plaque; 1.1-2.0 = Moderate accumulation of plaque; 2.1-3.0 = high accumulation of plaque. The Plaque index reference is Silness and Löe, 1964.
Time Frame
6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants > 20 years of age. Participants who master the Norwegian language. Participants who are registered at the university dental clinic (IKO). Exclusion Criteria: People who do not master the Norwegian language. Strongly visually impaired people that have difficulty in reading. People with a history of heart-attack in the past 6 months. Immune- compromised people and organ- transplanted people. People with other conditions that might lead to more disadvantages than advantages by participating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan O Bergdahl, Professor
Organizational Affiliation
University of Tromsoe, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Clinical Dentistry, University of Tromsø
City
Tromsø
ZIP/Postal Code
N-9037
Country
Norway
Facility Name
Public Dental Service Competence Centre of Northern Norway (TkNN)
City
Tromsø
ZIP/Postal Code
N-9037
Country
Norway

12. IPD Sharing Statement

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Oral Health Literacy Tailored Communication

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