Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000888460p
Ethics application status
Not yet submitted
Date submitted
16/07/2025
Date registered
15/08/2025
Date last updated
15/08/2025
Date data sharing statement initially provided
15/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of light curing silver diamine fluoride in hypomineralised permanent teeth
Scientific title
Effectiveness of light curing silver diamine fluoride in hypomineralised permanent teeth
Secondary ID [1] 314830 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypomineralised molars 338095 0
Condition category
Condition code
Oral and Gastrointestinal 334394 334394 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
All paediatric dental registrars will receive a face to face workshop on Silver Diamine Fluoride (SDF) use and application. Initial consultation will be a 45minute appointment in a hospital (Perth Children's Hospital) or university dental clinic (The Oral Health Centre of Western Australia) completed by the aforementioned registrars discussing the removal of the hypomineralised molars. All eligible patients will have already received information about this study prior to the consultation appointment. Parents interested will for their children to participate will then complete consent process prior to application of SDF as detailed below.

Application will require protective personal equipment (this includes safety glasses, a bib and vaseline applied to the lips of the patient). The tooth to be treated will be isolated using two cotton wool rolls placed buccally and lingually. Preoperative photographs will be taken using an intra oral photography mirror and DSLR camera. One standard drop of SDF will be dispensed in a dappen dish using the supplied dropper bottle. A microbrush will then be used to apply SDF onto the selected tooth for 60 seconds. This process will be the same for both groups.

The intervention group will subsequently receive a 20 second light cure using a light emitting diode (Valo Grand Cordless LED) on standard mode (900mW/cm2). Any residual SDF will be blot dried using a cotton wool roll. A post operative photograph will then be taken and the child will then be instructed to not eat or drink for 30mins as per standard SDF protocols.
Intervention code [1] 331434 0
Treatment: Drugs
Comparator / control treatment
SDF without light curing is the active control group. Other than the addition of light curing for the intervention group, the protocol will be the same for both groups.

Comparison will be made by assessing pre- and post-treatment sensitivity scores using the Schiff Cold Air Sensitivity Scale (SCASS).

Control group
Active

Outcomes
Primary outcome [1] 342077 0
Change in tooth sensitivity score using the Schiff Cold Air Sensitivity Scale (SCASS)
Timepoint [1] 342077 0
Immediately before intervention and again at follow-up visit (approximately 6–8 weeks post-intervention, on day of scheduled extraction under GA).
Secondary outcome [1] 449481 0
Staining of teeth pre and post application of SDF
Timepoint [1] 449481 0
Baseline (immediately prior to SDF+LC or SDF application) and at follow-up (6–8 weeks post-intervention, prior to scheduled extraction).

Eligibility
Key inclusion criteria
Children aged 6 to 15 years
Diagnosed with Molar Incisor Hypomineralisation (MIH) affecting permanent first molars
Referred to the Oral Health Centre of Western Australia (OHCWA) or Perth Children’s Hospital (PCH)
At least one hypomineralised permanent molar that is scheduled for extraction under general anaesthesia
Tooth must exhibit signs of sensitivity, post-eruptive breakdown, or structural compromise
Child and parent/guardian able to provide assent and informed consent
Minimum age
6 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Teeth with irreversible pulpitis or carious lesions involving the pulp
Children with a known allergy to silver, ammonia, or fluoride-containing products (e.g., SDF)
Presence of ulcerative gingival conditions or other significant oral mucosal lesions
Children who are unable or unwilling to cooperate with the treatment procedure
Teeth with gross structural damage that precludes effective application of the intervention

EDIT:
tick no

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Teeth will be allocated into either the intervention or control group. This would mean that one patient with multiple teeth that fit the inclusion criteria could be eligible for both treatment arms. Teeth will be treated based upon sequential allocation starting from the first tooth recruited in the trial (SDF only), the second tooth recruited will be SDF and light curing. Multiple teeth in a single patient will follow a quadrant by quadrant clockwise direction to maintain this order (eg upper right, upper left, lower left and lower right).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All numerical data, including cold air sensitivity scores and tooth shade measurements, will be entered into a dedicated, password-protected spreadsheet. Descriptive statistics (means, standard deviations, medians, and interquartile ranges, as appropriate) will be calculated and stratified by the degree of hypomineralisation at baseline.

To assess changes in cold air sensitivity following treatment, scores on the Schiff Cold Air Sensitivity Scale (SCASS) at baseline and follow-up (6–8 weeks post-application) will be compared within and between groups. Between-group comparisons (SDF alone vs. SDF with light curing) will be performed using chi-squared tests for categorical outcomes and repeated measures ANOVA or multivariate ANOVA (MANOVA) for continuous or ordinal SCASS scores, adjusting for baseline sensitivity and degree of hypomineralisation.

Tooth shade values (deltaE which measures perceptible change in shade) will be recorded using image J software. Mean changes in shade will be calculated for each group and compared using independent samples t-tests (or Mann–Whitney U tests if non-parametric) to evaluate differences between groups. Within-group comparisons will use paired t-tests or Wilcoxon signed-rank tests as appropriate.

A significance level of p less than 0.05 will be used for all hypothesis testing. All analyses will be conducted using SPSS (IBM Corp) or equivalent statistical software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
1/04/2026
Actual
Date of last data collection
Anticipated
3/06/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 28213 0
Perth Children's Hospital - Nedlands
Recruitment hospital [2] 28214 0
Oral Health Centre Western Australia - Nedlands
Recruitment postcode(s) [1] 44425 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 319389 0
University
Name [1] 319389 0
University internal funding - University of Western Australia Dental School
Country [1] 319389 0
Australia
Primary sponsor type
University
Name
UWA Dental School
Address
Country
Australia
Secondary sponsor category [1] 321876 0
None
Name [1] 321876 0
Address [1] 321876 0
Country [1] 321876 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318058 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 318058 0
Ethics committee country [1] 318058 0
Australia
Date submitted for ethics approval [1] 318058 0
22/08/2025
Approval date [1] 318058 0
Ethics approval number [1] 318058 0

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

Contacts
Principal investigator
Name 142706 0
Dr Mohamed Halane
Address 142706 0
Perth Children's Hospital. 17 Monash Avenue, Nedlands 6009, Western Australia
Country 142706 0
Australia
Phone 142706 0
+61432153167
Fax 142706 0
Email 142706 0
[email protected]
Contact person for public queries
Name 142707 0
Mohamed Halane
Address 142707 0
Perth Children's Hospital. 17 Monash Avenue, Nedlands 6009, Western Australia
Country 142707 0
Australia
Phone 142707 0
+618 6457 4400
Fax 142707 0
Email 142707 0
[email protected]
Contact person for scientific queries
Name 142708 0
Mohamed Halane
Address 142708 0
Perth Children's Hospital. 17 Monash Avenue, Nedlands 6009, Western Australia
Country 142708 0
Australia
Phone 142708 0
+618 6457 4400
Fax 142708 0
Email 142708 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No data will be shared unless specific ethical approval is received



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.