A comparison between two silver fluoride materials on dental caries management in an adult special needs populatio

Not Applicable

Recruiting

• Conditions: Dental Caries; Gingival Changes; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621001139864
• Lead Sponsor: niversity of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-23
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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];Development of gingivitis 3-4 months after application of the two silver fluoride materials.<br>Gingivitis will be assessed using non-invasive, commonly used Modified Gingival index (MGI) by Lobene 1989. [Baseline, 3-4 months post intervention]