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Oral Health Literacy Tailored Communication

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01118143
Enrollment
179
Registered
2010-05-06
Start date
2010-06-30
Completion date
2012-02-29
Last updated
2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Calculus, Dental Plaque, Lactobacillus Infection, Periodontal Diseases, Sialorrhea, Streptococcal Infections

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.

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.

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.

Sponsors

University of Tromso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Gingival Index6 months after interventionThe 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

MeasureTime frameDescription
Plaque Index6 months after interventionThe 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.

Countries

Norway

Participant flow

Recruitment details

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.

Pre-assignment details

Enrolled participants: Total excluded n=46 * Not meeting the inclusion criteria (n=11) * Declined to participate (n=35)

Participants by arm

ArmCount
Individualized Oral Health Instruction
Individualized oral health instruction adapted to the patients oral health literacy level
64
Ordinary Oral Health Instruction
Oral health instruction commonly used in general practice
69
Total133

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject25

Baseline characteristics

CharacteristicTotalIndividualized Oral Health InstructionOrdinary Oral Health Instruction
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
16 Participants10 Participants6 Participants
Age, Categorical
Between 18 and 65 years
117 Participants54 Participants63 Participants
Age, Continuous47.9 years
STANDARD_DEVIATION 14.73
49.7 years
STANDARD_DEVIATION 15.19
46.4 years
STANDARD_DEVIATION 14.23
health literacy level
Adequate health literacy
33 paticipants13 paticipants20 paticipants
health literacy level
Inadequate health literacy
39 paticipants15 paticipants24 paticipants
health literacy level
Marginal health literacy
61 paticipants36 paticipants25 paticipants
Region of Enrollment
Norway
133 participants64 participants69 participants
Sex: Female, Male
Female
76 Participants39 Participants37 Participants
Sex: Female, Male
Male
57 Participants25 Participants32 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 640 / 69
serious
Total, serious adverse events
0 / 640 / 69

Outcome results

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.

Time frame: 6 months after intervention

ArmMeasureValue (MEAN)Dispersion
Individualized Oral Health InstructionGingival Index0.7190 units on a scaleStandard Deviation 0.41599
Ordinary Oral Health InstructionGingival Index1.1152 units on a scaleStandard Deviation 0.45838
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.

Time frame: 6 months after intervention

ArmMeasureValue (MEAN)Dispersion
Individualized Oral Health InstructionPlaque Index0.0805 units on a scaleStandard Deviation 0.12958
Ordinary Oral Health InstructionPlaque Index0.3386 units on a scaleStandard Deviation 0.34694

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026