Oral Health Literacy Tailored Communication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Tromso
ClinicalTrials.gov Identifier:
NCT01118143
First received: April 28, 2010
Last updated: March 12, 2015
Last verified: March 2015
  Purpose

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.

Condition Intervention
Periodontal Diseases
Dental Plaque
Dental Calculus
Sialorrhea
Streptococcal Infections
Lactobacillus Infection
Behavioral: Tailored oral health literacy instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Communication Tailored to Oral Health Literacy Level of Adult Dental Patients: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Tromso:

Primary Outcome Measures:
  • Gingival Index [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months after intervention ] [ Designated as safety issue: No ]

    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.



Enrollment: 179
Study Start Date: June 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention group
Tailored oral health literacy instruction
Behavioral: 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 Name: Lifestyle counseling
No Intervention: control group
Oral health instruction not tailored to oral health literacy level

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118143

Locations
Norway
Institute of Clinical Dentistry, University of Tromsø
Tromsø, Norway, N-9037
Public Dental Service Competence Centre of Northern Norway (TkNN)
Tromsø, Norway, N-9037
Sponsors and Collaborators
University of Tromso
Investigators
Principal Investigator: Jan O Bergdahl, Professor University of Tromsoe, Norway
  More Information

Additional Information:
No publications provided

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT01118143     History of Changes
Other Study ID Numbers: UIT/TkNN
Study First Received: April 28, 2010
Results First Received: August 27, 2012
Last Updated: March 12, 2015
Health Authority: Norway: Directorate of Health

Additional relevant MeSH terms:
Periodontal Diseases
Streptococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on March 31, 2015