Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000769583
Ethics application status
Approved
Date submitted
14/05/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Novel white crowns for drill-free treatment of dental caries in New Zealand children
Scientific title
Novel white plastic crowns for drill-free treatment of dental caries in NZ children using the Hall Technique
Secondary ID [1] 312094 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 333728 0
Condition category
Condition code
Oral and Gastrointestinal 330411 330411 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
Developed novel white shell preformed crowns specially designed by the research team will be used.

The clinical procedure for the white shell crowns will follow the current protocol for the Hall Technique.
1) Children will be seated upright or lying down on a dental chair. O-rings will be placed in between teeth if space is inadequate; 2) Obvious food or debris will be washed from the cavity but no decay will be removed. 3) The correct size of white shell crown/metal PFC will be selected and tried on the tooth.; 4) The tooth and stainless-steel crown (SSC) will be rinsed and dried.; 5) The SSC will be filled with glass ionomer luting cement.; 6) The SSC will be placed firmly on the tooth and the child will be instructed to bite down until the crown is pushed over the tooth; 7) Extruded cement is then removed.

These clinical procedures will be carried out by trained dental therapists and/or oral health therapists at dental hubs within Southern Te Whatu Ora DHB. Multiple training sessions will be given to DTs/OHTs and the research team to ensure data accuracy and protocol compliance. The anticipated duration of the clinical procedures is 15 minutes per participant.
The feasibility clinical trial will end as soon as the target number of participants is reached.
Then the follow-up will take in place. In addition to 3-,6-, and 12-monthly phone calls, parents of participants will be encouraged to contact the research team or DT/OHT at any time for any concerns about the adverse effects of the treatment.
Intervention code [1] 328534 0
Treatment: Devices
Comparator / control treatment
New Zealand registered Dental Therapists and/or Oral Health Therapists currently employed with Te Whatu Ora DHB will carry out full clinical performance/treatment for preformed metal crowns over 5 to 15mins within their treatment/procedure time. The clinicians will document clinical dental examinations recording clinical and radiographical findings prior to their clinical decision. The procedure (the size of preformed metal crown used, cotton roll to bite down, wet gauze and knotted floss to remove excess luting cement and its success occlusion) will be thoroughly documented. A research assistant will be monitoring and recording any unexpected adverse events and/or unanticipated problems involving risk to participants or others throughout the feasibility study and the main study
Control group
Active

Outcomes
Primary outcome [1] 338209 0
Number of successful treatment deliveries completed using the white shell crown hall technique
Timepoint [1] 338209 0
Radiographical and clinical assessment at 6-monthly and 12-monthly follow-up only from the date of participants’ procedure.
Secondary outcome [1] 434989 0
Treatment experience (including acceptance) of the novel white shell crown system by children.
Timepoint [1] 434989 0
The questionnaire will be completed at the time of treatment and again at 6-monthly intervals for 2 years.
Secondary outcome [2] 436508 0
Treatment experience (including acceptance) of the novel white shell crown system by parents/caregivers.
Timepoint [2] 436508 0
The questionnaire will be completed at the time of treatment and again at 6-monthly intervals for 2 years.
Secondary outcome [3] 436509 0
Treatment experience (including acceptance) of the novel white shell crown system by dental practitioners
Timepoint [3] 436509 0
The questionnaire will be completed at the time of treatment and again at 6-monthly intervals for 2 years.

Eligibility
Key inclusion criteria
- all ethnicities, ages between 5-7 years
- willing to be examined by an oral health clinician
- any primary teeth requiring conventional Hall crowns (i.e. stainless-steel crowns) as a conservative treatment for dental caries
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Multiple metal PFCs already placed
- have teeth-grinding habits or bruxism.
- medically-compromised
- unable to complete questionnaire

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods such as Minimisation
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
23/12/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment outside Australia
Country [1] 26299 0
New Zealand
State/province [1] 26299 0
South Island

Funding & Sponsors
Funding source category [1] 316452 0
Government body
Name [1] 316452 0
Health Research Council (HRC) feasibility study fund
Country [1] 316452 0
New Zealand
Funding source category [2] 316489 0
Government body
Name [2] 316489 0
Ministry of Health Oral Health Research Grant
Country [2] 316489 0
New Zealand
Funding source category [3] 316490 0
Government body
Name [3] 316490 0
SfTi (Science for Technology and Innovation) Seed fund
Country [3] 316490 0
New Zealand
Funding source category [4] 316503 0
Other
Name [4] 316503 0
MedTech Core RAP Stage II Fund
Country [4] 316503 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 318682 0
None
Name [1] 318682 0
Address [1] 318682 0
Country [1] 318682 0
Other collaborator category [1] 283034 0
Hospital
Name [1] 283034 0
Te Whatu Ora Southern
Address [1] 283034 0
Country [1] 283034 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315243 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 315243 0
https://www.otago.ac.nz/council/committees/committees/humanethicscommittees
Ethics committee country [1] 315243 0
New Zealand
Date submitted for ethics approval [1] 315243 0
27/02/2023
Approval date [1] 315243 0
21/06/2023
Ethics approval number [1] 315243 0
2023 FULL 13593

Summary
Brief summary
Dental caries is the most common chronic childhood disease in New Zealand. Traditional treatment involves surgical removal of the infected dental tissues and restoration using a filling material. The Hall Technique (HT) is known as a ‘no drill, no pain’ restorative procedure using metal preformed crowns (PFCs). Although effective clinically, this technique has an aesthetic limitation—the crown is silver rather than tooth-coloured. The metal PFCs also have other disadvantages: cost to healthcare providers is high and placement can be difficult. Our research team has successfully developed a novel white shell crown system for the Hall Technique, improving both aesthetics and crown placement, while reducing treatment costs. Tooth-coloured prototype crowns have been validated; however, its clinical feasibility needs to be tested.
Trial website
Trial related presentations / publications
Public notes
The Ministry of Health has reported that Maori and Pasifika children are at a greater risk of developing dental caries. Although 95% of children are treated through the Community Oral Health Service in NZ, there is significant inequality in access to oral health care and oral health outcomes. Our proposed investigation of the effectiveness of the novel white shell crown system for drill-free caries management feasibility work centres on healthcare obligations under Te Tiriti o Waitangi for culturally-appropriate dental services that can aim for equity in best practice of dental caries treatment, especially for our Maori tamariki who experience higher rates of dental caries compared to non-Maori.
Written and/or verbal consent will be obtained from the parents (caregivers) and, where appropriate, assent from the children who have been recruited. A randomised clinical trial will be used for the feasibility study; child participants will receive at least a white PFC (Intervention group) or a metal PFC (Control group).

Contacts
Principal investigator
Name 134110 0
Dr Joanne Choi
Address 134110 0
310 Great King Street, Faculty of Dentistry, University of Otago, Dunedin 9016
Country 134110 0
New Zealand
Phone 134110 0
+64 0212139923
Fax 134110 0
Email 134110 0
joanne.choi@otago.ac.nz
Contact person for public queries
Name 134111 0
Joanne Choi
Address 134111 0
310 Great King Street, Faculty of Dentistry, University of Otago, Dunedin 9016
Country 134111 0
New Zealand
Phone 134111 0
+64 0212139923
Fax 134111 0
Email 134111 0
joanne.choi@otago.ac.nz
Contact person for scientific queries
Name 134112 0
Joanne Choi
Address 134112 0
310 Great King Street, Faculty of Dentistry, University of Otago, Dunedin 9016
Country 134112 0
New Zealand
Phone 134112 0
+64 0212139923
Fax 134112 0
Email 134112 0
joanne.choi@otago.ac.nz

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.