- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01118143
Oral Health Literacy Tailored Communication
Effects of Communication Tailored to Oral Health Literacy Level of Adult Dental Patients: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Tromsø, Norway, N-9037
- Institute of Clinical Dentistry, University of Tromsø
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Tromsø, Norway, N-9037
- Public Dental Service Competence Centre of Northern Norway (TkNN)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
Tailored oral health literacy instruction
|
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.
Other Names:
|
|
No Intervention: control group
Oral health instruction not tailored to oral health literacy level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gingival Index
Time Frame: 6 months after intervention
|
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.
|
6 months after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Index
Time Frame: 6 months after intervention
|
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. |
6 months after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan O Bergdahl, Professor, University of Tromsoe, Norway
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Stomatognathic Diseases
- Mouth Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Pathological Conditions, Anatomical
- Tooth Diseases
- Dental Deposits
- Salivary Gland Diseases
- Infections
- Communicable Diseases
- Calculi
- Periodontal Diseases
- Dental Plaque
- Sialorrhea
- Streptococcal Infections
- Dental Calculus
Other Study ID Numbers
- UIT/TkNN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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