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Trial registered on ANZCTR


Registration number
ACTRN12621001139864p
Ethics application status
Submitted, not yet approved
Date submitted
29/06/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between two silver fluoride materials on dental caries management in an adult special needs population
Scientific title
A comparison between silver fluoride/potassium iodide and silver fluoride/stannous fluoride on dental caries management in adult special needs population
Secondary ID [1] 304501 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental Caries 322353 0
Gingival Changes 322590 0
Condition category
Condition code
Oral and Gastrointestinal 320030 320030 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
Materials to be used:
- Silver Fluoride followed by Stannous fluoride
- Silver fluoride followed by potassium iodide

Procedure:
- Split mouth technique. Carious teeth selected will be the same type and, in the same arch but on opposing sides and on the buccal surface.
- In the first appointment, baseline measures will be undertaken by measuring bacterial load, plaque biofilm, dental caries extent, as well as information about patient demographics, medical/dental history, medications, diet and oral hygiene habits. Clinical photos will be taken pre-application and post-application of the products. One silver fluoride material will be applied on one side, the other silver fluoride material will be applied on the other side in the same arch
- The patient will then be recalled 3-4 months later on the second appointment where the same baseline measures will be undertaken so that comparison and analysis can be undertaken through clinical photos and data analysis.

Who will deliver the intervention
- The clinical data collection and application of the silver fluoride materials will be undertaken by a dental specialist or specialist in training in special needs dentistry

Mode of delivery:
- The two appointments required will be undertaken in clinical setting and face-to-face (90 minutes first appointment, 45 minutes second appointment)

Number of times intervention delivered:
- application of silver fluoride materials will be undertaken once (at the initial appointment)
- patient will need to return for follow up review at 3-4 months
- if required, patient will receive further treatment should caries progression be seen

Location where intervention will occur:
- Metropolitan public/community dental clinic
- Private Practice Specialist Needs Dentistry Specialist clinic (this has been added to enable a wider recruitment base to allow for meeting sample size criteria for the study)

Further treatment requirements:
- if a participant has caries progression detected at the 3-4month review appointment, depending on the rate of caries progression and size of cavity, either a second application of silver fluoride will be applied or a restoration (filling) will be undertaken with a suitable restorative material (eg. glass ionomer cement or composite). The decision to reapply with silver fluoride or undertake restoration will be based on the principles of minimal intervention dentistry and caries progression will be based on clinical visualisation of dental caries and presence/changes in the silver fluoride staining, readings of the diagnodent and gc tri-plaque gel staining.
Intervention code [1] 320862 0
Treatment: Drugs
Comparator / control treatment
Silver fluoride followed by stannous fluoride
Control group
Active

Outcomes
Primary outcome [1] 327890 0
Clinical outcome of caries progression between the two silver fluoride materials using laser induced fluorescence (Diagnodent) to provide quantitative measurements pre and post application of silver fluoride
Timepoint [1] 327890 0
Baseline, 3-4 months post intervention.
Primary outcome [2] 327891 0
Composition of dental plaque, assessed using GC-TriPlaque ID gel (a topical gel that identifies the maturity and acidogenicity of dental plaque on tooth surface) recorded using digital photography and assessed using image analysis of the dental plaque, immediately before and then 3-4 months after application of silver fluoride.
Timepoint [2] 327891 0
Baseline, 3-4 months post intervention
Primary outcome [3] 327892 0
Level of discolouration/staining of the treated surface, assessed using digital photography and analysis.
Timepoint [3] 327892 0
Baseline, 3-4 months post intervention
Secondary outcome [1] 396908 0
Gingival changes post application of the two silver fluoride materials. Gingival changes will be assessed using non-invasive, commonly used Modified Gingival index (MGI) by Lobene 1989.
Timepoint [1] 396908 0
Baseline, 3-4 months post intervention
Secondary outcome [2] 396909 0
Patient acceptability of any tooth surface staining caused by application of silver fluoride. This will be assessed using a study-specific questionnaire.
Timepoint [2] 396909 0
Baseline, 3-4 months post intervention
Secondary outcome [3] 396910 0
Tooth sensitivity of the site, before and after application of the two silver fluoride materials. This will be undertaken via a pain questionnaire using the visual analogue scoring (VAS) system
Timepoint [3] 396910 0
Baseline, 3-4 months post intervention
Secondary outcome [4] 398273 0
Development of gingivitis 3-4 months after application of the two silver fluoride materials.
Gingivitis will be assessed using non-invasive, commonly used Modified Gingival index (MGI) by Lobene 1989.
Timepoint [4] 398273 0
Baseline, 3-4 months post intervention

Eligibility
Key inclusion criteria
- Patients 18 years old and above with Special Needs (Special Needs as defined by AHPRA includes people with intellectual disability, medical, physical or psychiatric conditions)
- Minimal of two carious lesions on buccal surface with same presentation based on cavitated or non-cavitated carious lesion. Teeth selected will need to be of the same type and in the same arch but on opposing sides. They will need to be asymptomatic or have reversible pulpal symptoms and no periapical pathology
- Patients need to have ability to attend two appointments and compliant to the application process of the two silver fluoride products
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with known allergies or a history of adverse effects to silver fluoride, stannous fluoride or potassium iodide
- Carious lesions that have caused irreversible pulpal and periapical signs and symptoms
- Patients who are uncooperative/non-compliant to the initial application of the silver fluoride products
- Patients who fail to attend the review appointment
- Patients younger than 18 years of age

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)
Computer generated program that is on site and centralised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An online random number generator taken from: https://www.calculator.net/random-number-generator.html will be used to allocate materials to the treatment sites (left / right)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
For allocation right versus left, using Silver Fluoride/potassium iodide material
Even number = right; Odd number = Left.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statmate 2 for Windows software version 2.0 was used to calculate sample size estimation. A sample size of 20 will detect a difference of less than 5% with statistical power at 80% at a mean difference in the mean of 4.32. To account for an expected high rate of dropouts, 50 individuals with special needs aged 18 years or more will be recruited.

All raw data will be converted to a quantitative form for ease of analysis. Digital photographs of carious lesions, stained lesions and Tri-Plaque stained biofilm will be analysed digitally with Adobe Photoshop software. Statistical analysis will use Graphpad Prism (version 9) and Jamovi software. Bivariate and multivariate analyses will be conducted to compare measured outcomes. A p value of <0.05 will be used as the threshold for statistical significance. Key aspects of the analysis will be: (1) the clinical time taken to apply each product; (2) post-operative sensitivity (using VAS scores); (3) lesion bacterial load using Diagnodent fluorescence scores; (4) plaque metabolism using TriPlaque ID gel – expressed as a proportion of the three types of biofilm, (5) changes in lesion area and plaque biofilm area (based on pixel counts from images); (6) amount of gingival changes – scored from clinical images, (7) gingivitis at the follow-up visit (scored clinically), and (8) changes in lesion colour and tooth structure colour – from analysis of luminosity using Adobe Photoshop.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308864 0
University
Name [1] 308864 0
University of Queensland
Address [1] 308864 0
288 Herston Road
Herston, Queensland 4006
Country [1] 308864 0
Australia
Funding source category [2] 308865 0
Other Collaborative groups
Name [2] 308865 0
UQ School of Dentistry and Colgate-Palmolive Student Research Grant
Address [2] 308865 0
288 Herston Road, Herston Queensland 4006
Country [2] 308865 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
288 Herston Road,
Herston, Queensland 4006
Country
Australia
Secondary sponsor category [1] 309946 0
None
Name [1] 309946 0
Address [1] 309946 0
Country [1] 309946 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308773 0
Human Research Ethics Committees (HRECs) University of Queensland
Ethics committee address [1] 308773 0
288 Herston Road,
Herston, QLD 4006.
Ethics committee country [1] 308773 0
Australia
Date submitted for ethics approval [1] 308773 0
09/08/2021
Approval date [1] 308773 0
Ethics approval number [1] 308773 0

Summary
Brief summary
The purpose of this split mouth clinical study will explore differences in the clinical outcomes of Silver fluoride followed by potassium iodide (AgF/KI) and silver fluoride followed by stannous fluoride (AgF/SnF2). The outcomes will assess for how clinical performance is influenced by patient factors, such as their salivary profile, systemic conditions, medications, and diet. It is hypothesised that both materials will have similarities in its effects on clinical outcomes of dental caries management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111830 0
Dr Lydia See
Address 111830 0
Oral Health Centre, Herston
School of Dentistry, University of Queensland

288 Herston Road,
Herston Queensland 4006
Country 111830 0
Australia
Phone 111830 0
+61415822286
Fax 111830 0
Email 111830 0
l.see@uq.net.au
Contact person for public queries
Name 111831 0
Dr Lydia See
Address 111831 0
Oral Health Centre, Herston
School of Dentistry, University of Queensland

288 Herston Road,
Herston Queensland 4006
Country 111831 0
Australia
Phone 111831 0
+61415822286
Fax 111831 0
Email 111831 0
l.see@uq.net.au
Contact person for scientific queries
Name 111832 0
Dr Lydia See
Address 111832 0
Oral Health Centre, Herston
School of Dentistry, University of Queensland

288 Herston Road,
Herston Queensland 4006
Country 111832 0
Australia
Phone 111832 0
+61415822286
Fax 111832 0
Email 111832 0
l.see@uq.net.au

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 other documents available
Summary results
No Results