NCT01118143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

April 16, 2015

Status Verified

March 1, 2015

Enrollment Period

1.7 years

First QC Date

April 28, 2010

Results QC Date

August 27, 2012

Last Update Submit

March 26, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Plaque Index

    6 months after intervention

Study Arms (2)

intervention group

EXPERIMENTAL

Tailored oral health literacy instruction

Behavioral: Tailored oral health literacy instruction

control group

NO INTERVENTION

Oral health instruction not tailored to oral health literacy level

Interventions

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.

Also known as: Lifestyle counseling
intervention group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institute of Clinical Dentistry, University of Tromsø

Tromsø, N-9037, Norway

Location

Public Dental Service Competence Centre of Northern Norway (TkNN)

Tromsø, N-9037, Norway

Location

MeSH Terms

Conditions

Periodontal DiseasesDental PlaqueDental CalculusSialorrheaStreptococcal Infections

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesDental DepositsTooth DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSalivary Gland DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Professor Jan Bergdahl
Organization
University of Tromsø

Study Officials

  • Jan O Bergdahl, Professor

    University of Tromsoe, Norway

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 6, 2010

Study Start

June 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 16, 2015

Results First Posted

March 23, 2015

Record last verified: 2015-03

Locations