Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000844640
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
7/08/2014
Date last updated
6/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transform a Tooth with a Transformer Tooth: a randomised control trial of the Hall Technique compared with conventional restorative care in 3-7-year-old children in the New Zealand Community Oral Health Service with primary outcome of clinical and radiographic success
Scientific title
A randomised control trial of the Hall Technique compared with conventional restorative care for dental decay in 3-7-year-old children in the New Zealand Community Oral Health Service with primary outcome of clinical and radiographic success
Secondary ID [1] 284266 0
nil
Universal Trial Number (UTN)
U1111-1154-5280
Trial acronym
TAT Wanganui
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental caries 291387 0
Oral health related quality of life 291388 0
Condition category
Condition code
Oral and Gastrointestinal 291752 291752 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Hall Technique is a method of managing dental caries in primary molar teeth by cementing a preformed stainless steel crown onto the tooth on a single occasion without caries removal or local anaesthesia and takes approximately 10 minutes per tooth.
Intervention code [1] 288972 0
Treatment: Surgery
Comparator / control treatment
Conventional restorative care involves tooth preparation with caries removal and local anaesthesia when needed and in most cases placing a plastic restoration , and also sometimes a preformed stainless steel crown on a single occasion and takes approximately 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 291696 0
Survival of restoration without pain and infection detected clinically and radiographically
Timepoint [1] 291696 0
3 years
Secondary outcome [1] 307312 0
Family impact scale
Timepoint [1] 307312 0
3 years
Secondary outcome [2] 309783 0
Child health utility measure
Timepoint [2] 309783 0
Three years

Eligibility
Key inclusion criteria
Consenting child aged 3-7 years, free from complicating medical history, with 2 surface caries in molar tooth or teeth requiring treatment
Minimum age
3 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child unable to be examined due to inability to comply, no caries or only single surface caries, complicating medical history, outside age range.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Children who have consented to be part of the study will have dental examination and those fitting inclusion criteria will proceed in study. They will then be randomised to one or other treatment group by a sealed opaque envelope that is blinded to the clinician when assessing teeth for inclusion.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Electronic randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis
Data analyses will be performed using Stata Version IC12 (Stata Corp., College Station, TX, USA). Estimates of failure rates for conventional restorations (25%) and Hall technique SSCs (10%) are supported by our feasibility study and previous research. Data analysis will be conducted in four stages. In the first stage, descriptive statistics will be utilised to describe socio-demographic characteristics of participants in both intervention arms. In the second stage, Poisson regression will be applied to the primary outcomes of clinical and radiographic success, adjusting for socio-demographic characteristics and fluoridation status, and clustering for types of dental caries lesions. In the third stage, each scalar measure will be analysed using ordinal logistic regression, adjusting for socio-demographic characteristics and fluoridation status, and clustering for types of dental caries lesions. In the final stage, linear regression will be applied to laboratory data on caries progression for exfoliated teeth, adjusting for lesion depth, and clustering by lesion type, with treatment type as the exposure of interest.
Power Analysis & Sample Size Calculation
A feasibility study conducted in 2011-2012 indicated procedural success rates of 59.4% for conventional treatment and 93.1% for the Hall Technique at 24 month follow-up. Utilising this new data for sample size calculations, a conservative power analysis suggests a minimum of 32 in each arm, or 64 total (assuming alpha=0.05 and beta=0.90) Assuming 33% loss to follow-up over 3 years, we only need to to recruit 42 children in each arm (84 total). This data came in after the trial started and hence we stopped any further recruitment as we had enough children in each arm.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/06/2014
Actual
7/07/2014
Date of last participant enrolment
Anticipated
19/12/2014
Actual
20/12/2014
Date of last data collection
Anticipated
19/12/2017
Actual
19/12/2017
Sample size
Target
84
Accrual to date
Final
150
Recruitment outside Australia
Country [1] 5895 0
New Zealand
State/province [1] 5895 0
Wanganui

Funding & Sponsors
Funding source category [1] 288895 0
Charities/Societies/Foundations
Name [1] 288895 0
Cure Kids
Country [1] 288895 0
New Zealand
Funding source category [2] 288896 0
Other
Name [2] 288896 0
Whanganui District Health Board
Country [2] 288896 0
New Zealand
Funding source category [3] 288897 0
Commercial sector/Industry
Name [3] 288897 0
3M
Country [3] 288897 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
364 Leith Walk, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 287592 0
None
Name [1] 287592 0
Address [1] 287592 0
Country [1] 287592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290728 0
Northern B Health and Disibility Ethics Committee
Ethics committee address [1] 290728 0
Ethics committee country [1] 290728 0
New Zealand
Date submitted for ethics approval [1] 290728 0
19/03/2014
Approval date [1] 290728 0
29/04/2014
Ethics approval number [1] 290728 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46950 0
Dr Lyndie Foster Page
Address 46950 0
Dept Oral Rehabilitation
Faculty of Dentistry
University of Otago
PO Box 647
Dunedin 9054
Country 46950 0
New Zealand
Phone 46950 0
+64 3 4795853
Fax 46950 0
Email 46950 0
[email protected]
Contact person for public queries
Name 46951 0
Lyndie Foster Page
Address 46951 0
Dept Oral Rehabilitation
Faculty of Dentistry
University of Otago
PO Box 647
Dunedin 9054
Country 46951 0
New Zealand
Phone 46951 0
+64 3 4795853
Fax 46951 0
Email 46951 0
[email protected]
Contact person for scientific queries
Name 46952 0
Dorothy Boyd
Address 46952 0
Dept Oral Sciences
Faculty of Dentistry
University of Otago
PO Box 647
Dunedin 9054
Country 46952 0
New Zealand
Phone 46952 0
+64 3 4795853
Fax 46952 0
Email 46952 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Results: Of the 295 eligible children, 149 and 146... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of bitewing radiography on estimates of dental caries experience among children differs according to their disease experience.2018https://dx.doi.org/10.1186/s12903-018-0596-1
EmbaseA Primary Care Randomized Controlled Trial of Hall and Conventional Restorative Techniques.2021https://dx.doi.org/10.1177/2380084420933154
N.B. These documents automatically identified may not have been verified by the study sponsor.