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CompletedNCT01118143Updated Apr 16, 2015Results posted

Oral Health Literacy Tailored Communication

An interventional study of Tailored oral health literacy instruction in Periodontal Diseases, Dental Plaque and Dental Calculus, sponsored by University of Tromso. Completed at 2 sites in Norway. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-16.

Sponsored by University of Tromso · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
179
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Periodontal Diseases
  • Dental Plaque
  • Dental Calculus
  • Sialorrhea
  • Streptococcal Infections
  • Lactobacillus Infection
03

In context

Periodontal Diseases

867 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.

This study's enrollment of 179 is above the median of 45 across 557 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
179 participants (actual)

Study arms

  • Experimental
    intervention group

    Tailored oral health literacy instruction

    Behavioral: Tailored oral health literacy instruction

  • No intervention
    control group

    Oral health instruction not tailored to oral health literacy level

Interventions

  • BehavioralTailored 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.

    Also known as: Lifestyle counseling

06

What researchers measure

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.

    Time frame: 6 months after intervention

Secondary outcomes

  1. 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.

    Time frame: 6 months after intervention

07

Results

Posted Mar 23, 2015

Participant flow

Participants were recruited from the waiting list at Tromsø University Dental Clinic. The recruitment started in May 2010 after approval from the regional ethical committee. Information letter with consent form was provided.

Participant flow — Overall Study
MilestoneExperiment: Communication Adapted to Health Literacy LevelControl: Short Standard Information
Started6469
Completed6264
Not completed25
Withdrew: Withdrawal by subject25

Outcome measures

PrimaryGingival 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.

Time frame:
6 months after intervention
Reported as:
Mean · units on a scale
Gingival Index
units on a scaleIndividualized Oral Health InstructionOrdinary Oral Health Instruction
Gingival Index0.7190 ± 0.415991.1152 ± 0.45838
SecondaryPlaque 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.

Time frame:
6 months after intervention
Reported as:
Mean · units on a scale
Plaque Index
units on a scaleIndividualized Oral Health InstructionOrdinary Oral Health Instruction
Plaque Index0.0805 ± 0.129580.3386 ± 0.34694

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Individualized Oral Health Instruction—0/64 (0%)0/64 (0%)
Control—0/69 (0%)0/69 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Individualized Oral Health InstructionOrdinary Oral Health InstructionTotal
<=18 years000
Between 18 and 65 years5463117
>=65 years10616
Age, Continuous
Age, Continuous(years)Individualized Oral Health InstructionOrdinary Oral Health InstructionTotal
Mean49.7 ± 15.1946.4 ± 14.2347.9 ± 14.73
Sex: Female, Male
Sex: Female, Male(Participants)Individualized Oral Health InstructionOrdinary Oral Health InstructionTotal
Female393776
Male253257
Region of Enrollment
Region of Enrollment(participants)Individualized Oral Health InstructionOrdinary Oral Health InstructionTotal
Norway6469133
health literacy level
health literacy level(paticipants)Individualized Oral Health InstructionOrdinary Oral Health InstructionTotal
Inadequate health literacy152439
Marginal health literacy362561
Adequate health literacy132033
08

Study locations

2 sites
  • Institute of Clinical Dentistry, University of Tromsø
    Tromsø, N-9037, Norway
  • Public Dental Service Competence Centre of Northern Norway (TkNN)
    Tromsø, N-9037, Norway
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01118143
Lead sponsor
University of Tromso
Responsible party
Sponsor
First posted
May 6, 2010
Start date
Jun 2010
Primary completion
Feb 2012
Completion
Feb 2012
Results posted
Mar 23, 2015
Last update
Apr 16, 2015

Study contacts

Jan O Bergdahl, Professor
principal investigator · University of Tromsoe, Norway

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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