Periodontal DiseasesNCT01118143
Oral Health Literacy Tailored Communication
A study testing Tailored oral health literacy instruction in people with Periodontal Diseases and Dental Plaque, run by University of Tromso at 2 sites in Norway.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Dental Plaque, Dental Calculus
- What is being tested?
- Tailored oral health literacy instruction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesNorway
- Study dates
- Jun 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants > 20 years of age.
- Participants who master the Norwegian language.
- Participants who are registered at the university dental clinic (IKO).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Institute of Clinical Dentistry, University of Tromsø
Tromsø, N-9037
Public Dental Service Competence Centre of Northern Norway (TkNN)
Tromsø, N-9037
About this study
Official title: 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.
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.
- Conditions
- Periodontal Diseases, Dental Plaque, Dental Calculus, Sialorrhea, Streptococcal Infections, Lactobacillus Infection
- Being tested
- Tailored oral health literacy instruction
- Medical subject headings
- Periodontal Diseases, Dental Plaque, Dental Calculus, Sialorrhea, Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored oral health literacy instructionBehavioural
Also called Lifestyle counseling
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Tailored oral health literacy instruction Receives: Behavioral: Tailored oral health literacy instruction |
| control group | No intervention | Oral health instruction not tailored to oral health literacy level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startJun 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan O Bergdahl, Professor, Principal investigator, University of Tromsoe, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01118143
- Sponsor's protocol ID
- UIT/TkNN
- Status last verified
- Mar 2015
- First submitted
- 28 Apr 2010
- Last updated
- 16 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Communication Tailored to Oral Health Literacy Level of Adult Dental Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01118143
- Acronym / sponsor ID
- UIT/TkNN
- Conditions
- Periodontal Diseases, Dental Plaque, Dental Calculus, Sialorrhea, Streptococcal Infections, Lactobacillus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 23 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Tailored oral health literacy instructionTailored oral health literacy instruction |
| control group | No intervention | –Oral health instruction not tailored to oral health literacy level |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants > 20 years of age.
- Participants who master the Norwegian language.
- Participants who are registered at the university dental clinic (IKO).
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored oral health literacy instructionAlso: Lifestyle counselingThe 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. | Behavioural | intervention group |
Primary outcome
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.
1 secondary outcome
Plaque Index
Time frame: 6 months after intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan O Bergdahl, Professor principal investigator
University of Tromsoe, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored oral health literacy instruction in people with Periodontal Diseases and Dental Plaque, run by University of Tromso at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Index (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.