Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000729527
Ethics application status
Approved
Date submitted
29/06/2015
Date registered
15/07/2015
Date last updated
7/07/2020
Date data sharing statement initially provided
7/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Regular dental visits by public dental patients and impact on services provided and resource consumption in South Australia
Scientific title
Variation in dental recall intervals and their impact on resource consumption and services consumed: a randomised control trial among public dental patients in South Australia
Secondary ID [1] 287003 0
None
Universal Trial Number (UTN)
U1111-1171-6795
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 295470 0
oral health related quality of life 295472 0
dental fear and anxiety 295473 0
Condition category
Condition code
Oral and Gastrointestinal 295725 295725 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 295726 295726 0 0
Health service research
Mental Health 295771 295771 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
participants randomly assigned to dental recall intervals of 12-, 24-, 36-months and no specific recall interval. Participants will be contacted for a review appointment at allocated intervals by staff of the South Australian Dental Service. All participants will complete questionnaires at baseline and at 12-month intervals. Follow-up will conclude at 36-month recall appointments.
Intervention code [1] 292213 0
Treatment: Other
Intervention code [2] 292249 0
Prevention
Comparator / control treatment
No specific recall interval; participants will not be contacted for a specific review appointment, but will be advised to contact the local dental clinic if and when they feel they need to consult an oral health practitioner.
Control group
Active

Outcomes
Primary outcome [1] 295432 0
Presentation for emergency care outside of scheduled recall interval at any dental clinic, including private practices or hospitals will be obtained from patient data held by South Australian Dental Service via data linkage. Specifically designed questionnaire will seek information on attendance outside of South Australian Dental Service clinics at the completion of the 12-month questionnaires.
Timepoint [1] 295432 0
at time of presentation, monitored from enrolment for the duration of the study (36 months).
Primary outcome [2] 295433 0
oral health related quality of life assessed through completion of the Oral Health Impact Profile (OHIP-14) at the yearly questionnaire completion.
Timepoint [2] 295433 0
baseline, 12, 24, and 36 months
Primary outcome [3] 295434 0
dental fear and anxiety assessed through the completion of the index of dental anxiety and fear scale (IDAF-4C) at the yearly questionnaire completion.
Timepoint [3] 295434 0
baseline, 12, 24, and 36 months
Secondary outcome [1] 315573 0
Services received by patients will be coded at the level of individual service items using the three-digit coding scheme of the Australian Dental Association (ADA). Using this coding scheme, service items will be aggregated into one of 10 main areas of service, namely Diagnostic, Preventive, Periodontic, Oral Surgery, Endodontic, Restorative, Crown and Bridge, Prosthodontic, Orthodontic and General/Miscellaneous.
Timepoint [1] 315573 0
at time of presentation and 12, 24, 36 months

Eligibility
Key inclusion criteria
public dental patients within the South Australian Dental Service; aged 18-74; able to receive dental care in an ambulant condition
Minimum age
18 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
South Australian Dental Service identified special at risk groups

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
eligible participants attending selected South Australian Dental Service clinics will be issued with an information/consent pack and a self-complete questionnaire. Consenting participants will complete the questionnaire and sign a consent and return forms via reply-paid envelope to central study coordinator. Central study coordinator, off-site, will use computer-generated block random numbers to allocate participants, stratified by dental caries experience.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence will be generated using computer generated numbers stratified at two levels in blocks, stratified on caries experience and age-groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size estimation based on retrospective analysis of data from South Australian Dental Service over the period 2002-2012 of service use and attendance patterns among its patients and the frequency of attendance for emergency care after a course of general dental care. Forty-two percent attended for emergency care. The study is intended to reduce the proportion attending for emergency care by 50% with the institution of a scheduled recall to enable early care. The difference was to be statistically significant at alpha 0.05 and 0.80 power. Advice from the South Australian Dental Service was to anticipate an annual loss to follow-up of up to 50%. Allowing for loss to follow-up, an initial sample size of 720 in each group was required, rounded up to 3,000 for the entire sample.
Data will be analysed on an intention to treat basis and analysis of variance will be undertaken to determine services provided and resources consumed among the randomised groups. Group analysis of the proportion presenting for emergency care will be
undertaken using the Chi square statistic. Multiple linear modelling will be undertaken to determine factors of importance in changes to oral health related quality of life and dental fear and anxiety.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2015
Actual
1/09/2015
Date of last participant enrolment
Anticipated
31/08/2016
Actual
1/09/2016
Date of last data collection
Anticipated
1/09/2016
Actual
1/09/2016
Sample size
Target
3000
Accrual to date
Final
187
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 9885 0
5168 - Noarlunga Centre
Recruitment postcode(s) [2] 9886 0
5043 - Marion
Recruitment postcode(s) [3] 9887 0
5086 - Gilles Plains
Recruitment postcode(s) [4] 9888 0
5112 - Elizabeth
Recruitment postcode(s) [5] 9889 0
5092 - Modbury
Recruitment postcode(s) [6] 9890 0
5211 - Victor Harbor
Recruitment postcode(s) [7] 9891 0
5108 - Salisbury
Recruitment postcode(s) [8] 9892 0
5010 - Angle Park
Recruitment postcode(s) [9] 9893 0
5251 - Mount Barker
Recruitment postcode(s) [10] 9894 0
5015 - Port Adelaide
Recruitment postcode(s) [11] 9895 0
5118 - Gawler
Recruitment postcode(s) [12] 9896 0
5041 - Daw Park

Funding & Sponsors
Funding source category [1] 291559 0
Government body
Name [1] 291559 0
South Australian Dental Service
Country [1] 291559 0
Australia
Primary sponsor type
University
Name
University of Adelaide, Australian Research Centre for Population Oral Health
Address
122, Frome Street, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 290234 0
Government body
Name [1] 290234 0
South Australian Dental Service
Address [1] 290234 0
180, Flinders Street, Adelaide, SA 5000
Country [1] 290234 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293101 0
SA Health Human Research Ethics Committee
Ethics committee address [1] 293101 0
Ethics committee country [1] 293101 0
Australia
Date submitted for ethics approval [1] 293101 0
Approval date [1] 293101 0
11/02/2015
Ethics approval number [1] 293101 0
HREC/14/SAH/182

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 515 515 0 0
/AnzctrAttachments/368852-Final Approval Letter HREC-14-SAH-182.pdf

Contacts
Principal investigator
Name 58466 0
Dr peter arrow
Address 58466 0
Dental Health Services
43 Mt Henry Road
Como, 6152
Western Australia
Country 58466 0
Australia
Phone 58466 0
+61 08 93130600
Fax 58466 0
Email 58466 0
[email protected]
Contact person for public queries
Name 58467 0
peter arrow
Address 58467 0
Dental Health Services
43 Mt Henry Road
Como, 6152
Western Australia
Country 58467 0
Australia
Phone 58467 0
+61 08 93130600
Fax 58467 0
Email 58467 0
[email protected]
Contact person for scientific queries
Name 58468 0
peter arrow
Address 58468 0
Dental Health Services
43 Mt Henry Road
Como, 6152
Western Australia
Country 58468 0
Australia
Phone 58468 0
+61 08 93130600
Fax 58468 0
Email 58468 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.