Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000452998
Ethics application status
Approved
Date submitted
7/12/2019
Date registered
8/04/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
8/04/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to compare the decay arrest of two different fluoride products when applied to the teeth of children aged between 2 and 5 years in a rural setting near Port Moresby, Papua New Guinea.
Scientific title
Effectiveness of bi-annual application of 38% silver diamine fluoride solution compared to 5% sodium fluoride varnish on arrested carious lesions on primary teeth in children aged 2-5 years in a rural setting near Port Moresby, Papua New Guinea
Secondary ID [1] 299483 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 314713 0
Condition category
Condition code
Oral and Gastrointestinal 313049 313049 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
One local dental practitioner who is also in the research team will apply the medicaments to the teeth with signs of dental decay. The two treatment arms include:
Group 1: Bi-annual topical application of a thin film of 38% silver diamine fluoride solution and
Group 2: Bi-annual topical application of a thin film of 5% sodium fluoride varnish

Clinical examinations will be conducted at baseline, 6 and 12 months period. 38% SDF solution or 5% NaF varnish will be applied at baseline and re-applied during the second follow up visit in 6 months. Final data collection will be done at 12 months
Intervention code [1] 315734 0
Prevention
Intervention code [2] 315735 0
Treatment: Other
Comparator / control treatment
Active control 5% Sodium Fluoride
Control group
Active

Outcomes
Primary outcome [1] 321600 0
The primary outcome measure of the study is the number of active caries arrested at the end of the trial.
Progression of dental caries will be assessed using clinical examination and recording of data on the WHO oral health assessment form for children. Decayed, missing and filled surface (dmfs) scores will also be recorded at baseline and repeated at 6 and 12 months review. 38% SDF solution and 5% NaF varnish will be re-applied at 6months and the final review will be done at 12 months.
Measurement of arrested caries will be assessed by comparing the dmfs index of each child at baseline and 12-month review.
Timepoint [1] 321600 0
Base Line
Six months
Twelve months after the commencement of the trial ( primary endpoint)
Secondary outcome [1] 375551 0
Acceptability of the treatment by parent will be assessed by use of Likert scales and validated smiley faces
Timepoint [1] 375551 0
12months after commencement of the study
Secondary outcome [2] 380227 0
Acceptability of the treatment to the child will be assessed by use of Likert scales and validated smiley faces.
Timepoint [2] 380227 0
12 months

Eligibility
Key inclusion criteria
Children aged 2 to 5 years old from a rural village in Papua New Guinea
In good health
Have at least one carious tooth.
Have obtained informed consent and able to accept intervention
Minimum age
2 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children younger than two years or older than five years
Children who exhibit signs of tooth non-vitality such as pulp exposure, presence of
an abscess or sinus, hypermobility, retained roots of teeth
Children who are undergoing dental treatment or long-term medical treatment
Children with special healthcare needs,

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)
This study will be a randomized controlled trial with two parallel groups. In this study, the individual participants will serve as a unit of randomization.
Group 1: Bi-annual topical application of 38% Silver diamine fluoride solution and
Group 2: Bi-annual topical application of 5% sodium fluoride varnish

Computer-generated random numbers indicating the type of intervention were prepared and individually sealed in an opaque envelope. The opaque sealed envelopes were be kept by a person who will not be a part of the investigating team. Consequently, the participant’s group allocation information was be revealed only when the envelope is opened in front of the clinician at the time of application of the topical fluoride agents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software, computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Survey and clinical data will be transferred onto Windows excel spreadsheet in a de-identified format and analysed using Statistical Package for Social Sciences (SPSS, version 16.0) for windows.
An intention to treat analysis will be undertaken. Intra-examiner reproducibility and inter-examiner reproducibility in the diagnosis of caries will be assessed by Cohen’s Kappa statistic.
The primary outcome measures are the mean values of arrested caries lesions at 12 months and the mean number of new lesions that could develop over time.
Within-group changes in the mean number of arrested caries at 12 months and mean number of new caries lesions over time will be assessed by
employing repeated ANOVA (or Friedman test for Non-parametric data). Between-group comparisons of mean of arrested caries at 12 months and mean number of new carious lesions over time will be determined using t-test for independent sample test (or Mann- Whitney U test for non-parametric data). Subsequently, linear regression analysis will be conducted to determine the effect of the intervention (38% SDF vs 5% NaF) controlling for
baseline arrested caries, plaque levels, age, sex and socio-economic status.
Following on, regression analysis will be conducted based on the acceptability values at the end of the trial as the dependent variable accounting for the baseline factors: acceptability at baseline, oral hygiene, age, sex, and socio-economic status.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/12/2018
Date of last participant enrolment
Anticipated
Actual
14/12/2018
Date of last data collection
Anticipated
Actual
22/12/2019
Sample size
Target
104
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 21909 0
Papua New Guinea
State/province [1] 21909 0
Port Morseby

Funding & Sponsors
Funding source category [1] 303773 0
University
Name [1] 303773 0
Fuller Grant, Sir John Walsh Research Institute, University of Otago
Country [1] 303773 0
New Zealand
Funding source category [2] 303983 0
University
Name [2] 303983 0
. Health Education and Clinical Sciences Research Fund, School of Medicine and Health Sciences University of Papua New Guinea
Country [2] 303983 0
Papua New Guinea
Primary sponsor type
University
Name
University of Otago
Address
Alison Meldrum
Senior Lecturer
Department of Oral Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054



Country
New Zealand
Secondary sponsor category [1] 303892 0
University
Name [1] 303892 0
The University of Papua New Guinea
Address [1] 303892 0
Dr Mahmood Siddiqi
Division of Dentistry
School of Medicine & Health Sciences
The University of Papua New Guinea
PO Box 5623, BOROKO
National Capital District
Country [1] 303892 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304292 0
The University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 304292 0
Academic Committees
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 304292 0
New Zealand
Date submitted for ethics approval [1] 304292 0
15/10/2018
Approval date [1] 304292 0
20/11/2018
Ethics approval number [1] 304292 0
H18/120
Ethics committee name [2] 304481 0
Office of the Executive Dean
Ethics committee address [2] 304481 0
School of Medicine & Health Sciences
The University of Papua New Guinea
PO Box 5623, BOROKO
National Capital District
Ethics committee country [2] 304481 0
Papua New Guinea
Date submitted for ethics approval [2] 304481 0
12/09/2018
Approval date [2] 304481 0
11/10/2018
Ethics approval number [2] 304481 0
Letter of approval from the Chairman ( Professr N Tefuarani) School of Research and Ethics

Summary
Brief summary
The hypothesis is that bi-annual topical application of 38% silver diamine fluoride will be superior to bi-annual topical application of 5% sodium fluoride varnish in arresting dental decay in children 2-5 years of age. This is an interventional parallel arm, randomised study.
The participants will be recruited from a rural Papua New Guinean village. Consent will be obtain from the children and their guardian. The children will be clinically examined, visual and tactile, at baseline, 6 and 12 months by a callibrated dental practitioner.
Dental caries progression will be assessed and recorded. The primary outcome measure of the study is the number of active caries arrested at the end of the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96422 0
Mrs Alison Meldrum
Address 96422 0
Department of Oral Health
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 96422 0
New Zealand
Phone 96422 0
+64 3 4797113
Fax 96422 0
+64 3 4797113
Email 96422 0
[email protected]
Contact person for public queries
Name 96423 0
Alison Meldrum
Address 96423 0
Department of Oral Health
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 96423 0
New Zealand
Phone 96423 0
+6434797113
Fax 96423 0
+64 3 479 7113
Email 96423 0
[email protected]
Contact person for scientific queries
Name 96424 0
Alison Meldrum
Address 96424 0
Department of Oral Health
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 96424 0
New Zealand
Phone 96424 0
+6434797113
Fax 96424 0
+64 3 4797113
Email 96424 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
The participants in the trial were not asked for their consent to enable the public assess to their individual data. Thus we have no consent to share individual data.


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.