Authors
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University of Queensland -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: 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 ‐ Pri CONDITION: Dental Caries;Gingival Changes; ; Dental Caries ; Gingival Changes Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon PRIMARY OUTCOME: 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[Baseline, 3‐4 months post intervention.] 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.[Baseline, 3‐4 months post intervention] Level of discolouration/staining of the treated surface, assessed using digital photography and analysis.[Baseline, 3‐4 months post intervention] SECONDARY OUTCOME: Development of gingivitis 3‐4 months after application of the two silver fluoride materials. 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 ; Gingivitis will be assessed using non‐invasive, commonly used Modified Gingival index (MGI) by Lobene 1989. [Baseline, 3‐4 months post intervention] 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. [Baseline, 3‐4 months post intervention] Patient acceptability of any tooth surface staining caused by application of silver fluoride. This will be assessed using a study‐specific questionnaire.[Baseline, 3‐4 months post intervention] 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[Baseline, 3‐4 months post intervention]
Epistemonikos ID: be18986f5c1a542a27c2de19405a0c222df30053
First added on: Aug 25, 2024