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Trial registered on ANZCTR


Registration number
ACTRN12617001238369
Ethics application status
Approved
Date submitted
30/06/2014
Date registered
24/08/2017
Date last updated
24/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Northland Hall Technique Project: A randomised controlled clinical trial of 4 to 8 years old children having stainless steel crowns with either the Hall or conventional technique to examine if one method is superior to the other.
Scientific title
Northland Hall Technique Project:A randomised controlled clinical trial of 4 to 8 years old children having stainless steel crowns with either the Hall or conventional technique to examine if one method is superior to the other.
Secondary ID [1] 284882 0
Nil
Universal Trial Number (UTN)
U1111-1158-6381
Trial acronym
Snap - the NHTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Dental Caries 292320 0
Condition category
Condition code
Oral and Gastrointestinal 292656 292656 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 a tooth. This is without carious tissue removal and without local anaesthesia and takes approximately 10 minutes. Children will receive the Hall Technique treatment on one visit, and the conventional technique on a separate visit. The order of treatment (which comes first) and the tooth to receive the Hall technique will be randomised. The dental therapist will conduct the treatment, and the interval between appointments will be a minimum of 1 week, and maximum of 1 month.
Intervention code [1] 289692 0
Treatment: Surgery
Comparator / control treatment
Conventional SSC involves tooth preparation with carious tissue removal and local anaesthesia when needed and cementing a preformed stainless steel crown onto a tooth which takes approximately 30 minutes. Children will receive the Hall Technique treatment on one visit, and the conventional technique on a separate visit. The order of treatment (which comes first) and the tooth to receive the Hall technique will be randomised. The dental therapist will conduct the treatment, and the interval between appointments will be a minimum of 1 week, and maximum of 1 month.
Control group
Active

Outcomes
Primary outcome [1] 292503 0
Survival of restoration without pain and infection detected clinically and/or radiographically.
Timepoint [1] 292503 0
18 months
Secondary outcome [1] 309635 0
Child reported pain from treatment will be recorded immediately after each treatment and 1 week after each treatment using a validated child-report questionnaire, the Wong-Baker pain scale.
Timepoint [1] 309635 0
Children will be asked about pain at treatment immediately after the treatment, and pain from the treated tooth 1 week after the treatment appointment.
Secondary outcome [2] 337695 0
As anxiety has a bearing on pain, children will complete the Modified Child Dental Anxiety Scale faces version (MCDASf)
Timepoint [2] 337695 0
MCDASf will be conducted at baseline and 6 month and 18 month follow-up visits.
Secondary outcome [3] 337696 0
A subgroup of children in the study will be recorded audiovisually and assessment made of coping or distressed behaviour at time of treatment using coding of the behaviours seen based on the CAMPISr coding system (Child-Adult Medical Procedure Interaction Scale revised).
Timepoint [3] 337696 0
At one treatment visit audiovisual recording will take place for later coding of the videos by researchers.

Eligibility
Key inclusion criteria
Consenting children and their parents/caregivers. Children aged 4-8years, free from complicating medical history, with 2 or more surface caries in primary molar tooth or teeth requiring treatment.
Minimum age
4 Years
Maximum age
8 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 the inclusion criteria will proceed in the study. They will be randomised at that stage to one or other treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central computer generated randomisation is used to assign order of treatment (first or second) and method of treatment (Hall or Conventional). The randomisation codes are provided to clinicians in sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Other
Other design features
Split-mouth cross-over study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / 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 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 clustering for types of dental caries lesions. Qualitative data will be analysed to look for themes. Triangualtion will be used to ensure all themes are identified.


Power Analysis & Sample Size Calculation

A feasibility study conducted in 2011-2012 indicated procedural success rates of 88.4% for conventional treatment and 96.0% for the Hall Technique at six-month follow-up. Utilising these data for sample size calculations, a conservative power analysis suggested a minimum of 288 children is needed (assuming alpha=0.05 and beta=0.90).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
2/02/2015
Date of last participant enrolment
Anticipated
Actual
3/06/2016
Date of last data collection
Anticipated
29/12/2017
Actual
Sample size
Target
288
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 6179 0
New Zealand
State/province [1] 6179 0
Northland

Funding & Sponsors
Funding source category [1] 289505 0
Government body
Name [1] 289505 0
Lotteries Health Research
Country [1] 289505 0
New Zealand
Funding source category [2] 289506 0
Other
Name [2] 289506 0
Northland District Health Board
Country [2] 289506 0
New Zealand
Funding source category [3] 289507 0
Commercial sector/Industry
Name [3] 289507 0
3M
Country [3] 289507 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] 288186 0
None
Name [1] 288186 0
Address [1] 288186 0
Country [1] 288186 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291252 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 291252 0
Ethics committee country [1] 291252 0
New Zealand
Date submitted for ethics approval [1] 291252 0
18/07/2014
Approval date [1] 291252 0
15/09/2014
Ethics approval number [1] 291252 0
14/NTA/141

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

Contacts
Principal investigator
Name 49530 0
Dr Lyndie Foster Page
Address 49530 0
Dept Oral Sciences, Faculty of Dentistry, University of Otago, PO Box 647, Dunedin 9054
Country 49530 0
New Zealand
Phone 49530 0
+64 3 4795853
Fax 49530 0
Email 49530 0
[email protected]
Contact person for public queries
Name 49531 0
Lyndie Foster Page
Address 49531 0
Dept Oral Rehabilitiation, Faculty of Dentistry, University of Otago, PO Box 647, Dunedin 9054
Country 49531 0
New Zealand
Phone 49531 0
+64 3 4795853
Fax 49531 0
Email 49531 0
[email protected]
Contact person for scientific queries
Name 49532 0
Dorothy Boyd
Address 49532 0
Dept Oral Sciences, Faculty of Dentistry, University of Otago, PO Box 647, Dunedin 9054
Country 49532 0
New Zealand
Phone 49532 0
+64 3 4794275
Fax 49532 0
Email 49532 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

Documents added automatically
No additional documents have been identified.