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Trial registered on ANZCTR


Trial ID
ACTRN12612000547842
Ethics application status
Approved
Date submitted
19/05/2012
Date registered
23/05/2012
Date last updated
31/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Enhancing oral health via sense of coherence: a cluster randomized trial
Scientific title
The effect of an intervention to enhance sense of coherence on oral health related quality of life in Thai schoolchildren
Secondary ID [1] 280515 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral health related quality of life 286504 0
Condition category
Condition code
Public Health 286765 286765 0 0
Health promotion/education
Oral and Gastrointestinal 286786 286786 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention to improve oral health related quality of life via enhancing sense of coherence which is a psychological or individual factor. The intervention consists of seven 40-60 minute sessions over two months, focusing on child participation and empowerment. The first four sessions are classroom activities and include a mixture of didactic teaching, discussion, activities and games. The last three involve working on healthy school projects Children were encouraged and empowered to do the projects by brainstorming, discussing, planning, implementation and evaluation. The activities in the projects included suggesting to other students to choose healthy food, teaching others to brush their teeth effectively, cooperating with teachers to run a tuck shop to provide healthy food. These projects involved the whole school.

The intervention was delivered by trained teachers who received an intensive one day course run by the researcher
Intervention code [1] 284889 0
Prevention
Intervention code [2] 284890 0
Lifestyle
Intervention code [3] 284891 0
Behaviour
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 287151 0
Oral health related quality of life (OHRQoL) was assessed using the 37-item Child Perception Questionnaire (CPQ11-14)
Timepoint [1] 287151 0
3 time points; baseline, 2 weeks after the intervention and 3 months after the intervention
Secondary outcome [1] 297501 0
sense of coherence (SOC) was measured using 13-item SOC questionnaire
Timepoint [1] 297501 0
3 timepoints; baseline, 2 weeks after the intervention and 3 months after the intervention
Secondary outcome [2] 297502 0
Oral health beliefs (OHBs) was assessed using 6-item oral health beliefs questionnaire.
Timepoint [2] 297502 0
3 timepoints; baseline, 2 weeks after the intervention and 3 months after the intervention
Secondary outcome [3] 297503 0
Clinical data (e.g. DMFT and gingival health)
Timepoint [3] 297503 0
2 timepoints; baseline and at 3 month follow-up
Secondary outcome [4] 297504 0
General health perceptions were measured using 1 single item questionnaire. The question was worded as 'Would you say that the health of your teeth, lips, jaws and mouth is...?' with five-point response format ranging from
'Excellent' = 0 to 'Poor' = 4. This question is validated, presented in CPQ11-14 and has acceptable construct validity in relation to CPQ11-14 (Jokovic et al., 2002)
Timepoint [4] 297504 0
3 timepoints; baseline, 2 weeks after the intervention and 3 months after the intervention
Secondary outcome [5] 297505 0
Overall quality of life was measured using 1 single item questionnaire. The question was worded as 'How much does the condition of your teeth, lips, jaws or mouth affect your life overall?' with five point response format ranging from 'Not at all'= 0 to 'Very much' = 4. This question is validated, presented in CPQ11-14 and has acceptable construct validity in relation to CPQ11-14 (Jokovic et al., 2002)
Timepoint [5] 297505 0
3 timepoints; baseline, 2 weeks after the intervention and 3 months after the intervention
Secondary outcome [6] 297506 0
Demographic factors were assessed using the parents' questionnaire
Timepoint [6] 297506 0
Baseline

Eligibility
Key inclusion criteria
For schools, each primary school was located in a suburban area in Khonkaen and had 200-300 students in total, including 20-30 children in Grade 5.

For participants, children in Grade 5 who attended the primary schools.
Minimum age
10 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children whose parents did not provide consent to participate in the study
2. Children who did not have the ability to complete the questionnaires
3. Children who had medical and cognitive problems
4. Children who declined to take part

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation used block permutation to balance the number of schools/participants in each group. The schools were listed. Then a random sequence of blocks of 4 was created and the first point in the sequence was selected by a person not involved in the project. Schools were allocated to the two groups according to the sequence. Six schools were randomly assigned to the intervention and the comparison groups respectively.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4324 0
Thailand
State/province [1] 4324 0

Funding & Sponsors
Funding source category [1] 285279 0
Government body
Name [1] 285279 0
Royal Thai government, Ministry of Public Health, Thailand via a doctoral studentship to Orawan Nammontri
Address [1] 285279 0
Office of Educational Affairs
Royal Thai Embassy
28 Prince's Gate
London, SW7 1PT
U.K
Country [1] 285279 0
United Kingdom
Primary sponsor type
Government body
Name
Royal Thai government, Ministry of Public Health, Thailand via a doctoral studentship to Orawan Nammontri
Address
Office of Educational Affairs
Royal Thai Embassy
28 Prince’s Gate
London, SW7 1PT
U.K
Country
United Kingdom
Secondary sponsor category [1] 284139 0
University
Name [1] 284139 0
University of Sheffield
Address [1] 284139 0
Unit of Dental Public Health
School of Clinical Dentistry,
Claremont Crescent,
University of Sheffield,
S10 2TA,
UK
Country [1] 284139 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287292 0
the Ethical Review Committee for Research in Human Subjects: Ministry of Public Health, Thailand
Ethics committee address [1] 287292 0
Ethics committee country [1] 287292 0
Thailand
Date submitted for ethics approval [1] 287292 0
Approval date [1] 287292 0
23/12/2009
Ethics approval number [1] 287292 0

Summary
Brief summary
The aim of this study was to investigate the effect of an intervention to enhance sense of coherence and oral health related quality of life and explore determinants of oral health related quality of life in children.

Main hypotheses
1. The school-based intervention increases sense of coherence
2. The intervention to enhance sense of coherence improves oral health related quality of life
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34198 0
Address 34198 0
Country 34198 0
Phone 34198 0
Fax 34198 0
Email 34198 0
Contact person for public queries
Name 17445 0
Orawan Nammontri
Address 17445 0
Unit of Dental Public Health
School of Clinical Dentistry,
Claremont Crescent,
University of Sheffield,
S10 2TA,
UK
Country 17445 0
United Kingdom
Phone 17445 0
+44 1142717877
Fax 17445 0
Email 17445 0
Orawann16@hotmail.com, mdp08on@sheffield.ac.uk
Contact person for scientific queries
Name 8373 0
Orawan Nammontri
Address 8373 0
Unit of Dental Public Health
School of Clinical Dentistry,
Claremont Crescent,
University of Sheffield,
S10 2TA,
UK.
Country 8373 0
United Kingdom
Phone 8373 0
+44 1142717877
Fax 8373 0
Email 8373 0
Orawann16@hotmail.com, mdp08on@sheffield.ac.uk