Oral Health Literacy Tailored Communication

Periodontal Diseases Clinical Trial

Official title:

Effects of Communication Tailored to Oral Health Literacy Level of Adult Dental Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01118143
• Other study ID #: UIT/TkNN
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: March 26, 2015
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: March 2015
• Source: University of Tromso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Calculus
• Dental Plaque
• Gingival Diseases
• Infection
• Lactobacillus Infection
• Periodontal Diseases
• Sialorrhea
• Streptococcal Infections

Intervention

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.

Locations

Country	Name	City	State
Norway	Institute of Clinical Dentistry, University of Tromsø	Tromsø
Norway	Public Dental Service Competence Centre of Northern Norway (TkNN)	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after intervention	No
Secondary	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.	6 months after intervention	No