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Preventive Effects of Silver Diamine Fluoride on Early Enamel Caries

ConditionsDemineralization, ToothWhite Spot Lesion of ToothFixed AppliancesEarly Caries Lesions
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Malaysia

About this trial

Fixed orthodontic patients are at risk of developing dental caries. Topical application of fluoride varnish (FV) around the orthodontic brackets and using fluoridated mouth rinses have been suggested to prevent the formation of white spot lesions (WSLs) on enamel. Recent studies have shown that silver diamine fluoride (SDF) demonstrated better outcomes in dental caries prevention as compared to FV. However, the caries preventive effects of SDF application around the orthodontic brackets have not been established yet.

This study will be conducted to evaluate the effectiveness of SDF in preventing WSLs formation in patients undergoing fixed orthodontic treatment. This study will use a randomised-controlled double-blinded design with three parallel arms. Ninety-nine eligible participants will be recruited. Using their registration number, a random list of patients will be generated using computer software. Each patient will be assigned randomly to three groups: SDF, FV, or placebo. Digital photographs of upper anterior teeth (frontal view) will be taken as a baseline and repeated at every review appointment. The materials will be applied around the orthodontic bracket of upper incisors and canines every 6 months. The formation of WSLs around the bracket will be evaluated at 1, 3, 6, and 12 months using three parameters: the ICDAS scoring system, the laser fluorescence caries detector, and digital photographic analysis using the Gorelick score. The patients' perception of the colour changes of the enamel will be evaluated through patient-reported outcomes. The difference in ICDAS and Gorelick scores and the patients' perceptions will be reported through descriptive statistics. The Kruskal-Wallis or one-way ANOVA statistical test will be used to compare the changes in fluorescence intensity between treatment groups.

The investigators believe that the results of this study will provide insight into the caries preventive protocol among fixed orthodontics patients and subsequently reduce the incidence of WSLs during orthodontic treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects about to undergo fixed orthodontic treatment at the Faculty of Dentistry, UKM.

Subjects must be aged 18 years and above.

Consented for treatment. Patients will be informed of the risk and benefit of the study for each treatment group through the patient information sheet given to them before obtaining their consent.

Orthodontic brackets placed at least on the upper incisors.

Disqualifiers

History of fixed orthodontic treatment

Presence of any dental anomalies or developmental defects of enamel (DDE) on labial surfaces of teeth, such as preexisting fluorosis or enamel hypoplasia.

Presence of any or direct/indirect restorations on the labial surface of teeth

History of long-term antibiotic usage

Trial design

Design model

Parallel

Treatments tested in this trial

  • Silver diamine fluoride- potassium iodide

    Drug

    SDF , Riva Star, SDI Limited., Australia

  • Fluoride varnish

    Drug

    Duraphat varnish®, Colgate-Palmolive (UK) Ltd.

  • 0.9 % saline

    Other intervention

    Standard oral hygiene instructions every 3 months and application of Normal Saline for every 6 months

Treatment groups

99 Participants
are divided into 3 treatment groups
Group A: Standard of care + Silver Diamine Fluoride (SDF)Experimental treatment 1 intervention
Group B: Standard of care + Fluoride varnishActive comparator 1 intervention
Group C: Standard of care + Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Formation of Early Enamel Caries Analyzed Through Digital Photography

Changes in enamel surface following decalcification, measured using the Gorelick's Index (1982) in all three intervention groups. Gorelick's Index Scale: 0 - No lesion (best outcome) 1. \- Moderate lesion 2. \- Severe lesion 3. \- Cavitation (worst outcome) Lower scores represent better outcomes, while higher scores indicate poorer outcomes.

Time frame
12 months
2

Formation of Early Enamel Caries Assessed Clinically by a Blinded Assessor

Changes in enamel surface following decalcification, measured clinically using the International Caries Detection and Assessment System II (ICDAS II) Index (2005) in all three intervention groups. ICDAS II Scale: 0 - Sound tooth surface: No evidence of caries after 5 seconds of air drying (best outcome) 1. \- First visual change in enamel: Opacity or discoloration (white or brown) visible after prolonged air drying 2. \- Distinct visual change in enamel visible when wet; lesion must be visible when dry 3. \- Localized enamel breakdown (without clinical visual signs of dentinal involvement), seen when wet and after prolonged drying 4. \- Underlying dark shadow from dentine 5. \- Distinct cavity with visible dentine 6. \- Extensive (more than half the surface) distinct cavity with visible dentine (worst outcome) Lower scores represent better outcomes, while higher scores indicate poorer outcomes.

Time frame
12 months
3

Change in Laser Fluorescence Values

Changes in mean DIAGNOdent scores among the three study groups. DIAGNOdent Scale: 0-13 - Sound tooth surface (best outcome) 14-20 - Enamel caries \>20 - Dentinal caries (worst outcome) Lower readings represent better outcomes, while higher readings indicate poorer outcomes.

Time frame
12 months
4

Participants Perspectives on Tooth Colour Changes After Silver Diamine Fluoride (SDF) Application: Participants-Reported Outcome

Participants perceptions of visible colour changes following SDF application will be evaluated using a structured questionnaire at baseline and follow-up appointments (1, 3, 6, and 12 months). Participants will report whether they notice any colour changes and indicate their satisfaction with the appearance of their teeth.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Malaysia

Lead sponsor

Source ClinicalTrials.gov

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