None listed
Conditions
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.
Interventions
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 o
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.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed