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Trial registered on ANZCTR
Registration number
ACTRN12621001139864
Ethics application status
Approved
Date submitted
29/06/2021
Date registered
23/08/2021
Date last updated
11/08/2022
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
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Scientific title
A comparison between silver fluoride/potassium iodide and silver fluoride/stannous fluoride on dental caries management in adult special needs population
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Secondary ID [1]
304501
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dental Caries
322353
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Gingival Changes
322590
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Condition category
Condition code
Oral and Gastrointestinal
320030
320030
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
320862
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Treatment: Drugs
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Comparator / control treatment
Silver fluoride followed by stannous fluoride
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Control group
Active
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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Baseline, 3-4 months post intervention.
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Primary outcome [2]
327891
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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.
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Assessment method [2]
327891
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Timepoint [2]
327891
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Baseline, 3-4 months post intervention
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Primary outcome [3]
327892
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Level of discolouration/staining of the treated surface, assessed using digital photography and analysis.
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Assessment method [3]
327892
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Timepoint [3]
327892
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Baseline, 3-4 months post intervention
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Secondary outcome [1]
396908
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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.
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Assessment method [1]
396908
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Timepoint [1]
396908
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Baseline, 3-4 months post intervention
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Secondary outcome [2]
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Patient acceptability of any tooth surface staining caused by application of silver fluoride. This will be assessed using a study-specific questionnaire.
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Assessment method [2]
396909
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Timepoint [2]
396909
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Baseline, 3-4 months post intervention
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Secondary outcome [3]
396910
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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
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Assessment method [3]
396910
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Timepoint [3]
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Baseline, 3-4 months post intervention
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Secondary outcome [4]
398273
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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.
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Assessment method [4]
398273
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Timepoint [4]
398273
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Baseline, 3-4 months post intervention
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated program that is on site and centralised.
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Other
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Other design features
For allocation right versus left, using Silver Fluoride/potassium iodide material
Even number = right; Odd number = Left.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/10/2021
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Actual
3/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
50
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Accrual to date
8
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
308864
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University
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Name [1]
308864
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University of Queensland
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Address [1]
308864
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288 Herston Road
Herston, Queensland 4006
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Country [1]
308864
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Australia
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Funding source category [2]
308865
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Other Collaborative groups
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Name [2]
308865
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UQ School of Dentistry and Colgate-Palmolive Student Research Grant
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Address [2]
308865
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288 Herston Road, Herston Queensland 4006
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Country [2]
308865
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Australia
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Primary sponsor type
University
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Name
University of Queensland
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Address
288 Herston Road,
Herston, Queensland 4006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
309946
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Address [1]
309946
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Country [1]
309946
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
308773
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Metro North Health HREC A
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Ethics committee address [1]
308773
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HREC Office, Executive Suites, Lower Ground Floor,
Dr James Mayne Building, RBWH
RGO Office, Level 4, UQCCR, RBWH
Butterfield Street, Herston Qld 4029
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Ethics committee country [1]
308773
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Australia
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Date submitted for ethics approval [1]
308773
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09/08/2021
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Approval date [1]
308773
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13/09/2021
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Ethics approval number [1]
308773
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HREC/2021/QRBW/73736
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Ethics committee name [2]
311440
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Human Research Ethics Committees (HRECs) University of Queensland
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Ethics committee address [2]
311440
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288 Herston Road, Herston, QLD 4006
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Ethics committee country [2]
311440
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Australia
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Date submitted for ethics approval [2]
311440
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Approval date [2]
311440
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11/10/2021
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Ethics approval number [2]
311440
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2021/HE002354
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Lydia See
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Address
111830
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Oral Health Centre, Herston
School of Dentistry, University of Queensland
288 Herston Road,
Herston Queensland 4006
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Country
111830
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Australia
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Phone
111830
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+61415822286
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Fax
111830
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Email
111830
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[email protected]
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Contact person for public queries
Name
111831
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Dr Lydia See
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Address
111831
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Oral Health Centre, Herston
School of Dentistry, University of Queensland
288 Herston Road,
Herston Queensland 4006
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Country
111831
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Australia
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Phone
111831
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+61415822286
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Fax
111831
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Email
111831
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[email protected]
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Contact person for scientific queries
Name
111832
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Dr Lydia See
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Address
111832
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Oral Health Centre, Herston
School of Dentistry, University of Queensland
288 Herston Road,
Herston Queensland 4006
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Country
111832
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Australia
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Phone
111832
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+61415822286
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Fax
111832
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Email
111832
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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