A Phase 2 interventional study of Silver diamine fluoride- potassium iodide and Fluoride varnish in Demineralization, Tooth, White Spot Lesion of Tooth and Fixed Appliances, sponsored by National University of Malaysia. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by National University of Malaysia · Phase 2, Interventional, and Prevention
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.
Fixed orthodontic appliances are commonly used to correct malocclusions and align teeth in orthodontic treatment. Fixed orthodontic appliances consist of several components, each serving a specific function in the orthodontic treatment process. These components typically include brackets, arch wires, ligatures (or ties), and occasionally auxiliary components such as springs or elastics. It involves the placement of orthodontic brackets, secured to the teeth surface with a composite resin material. Slots on the brackets are used to hold the orthodontic wires, which act as a means of transmitting forces to the teeth for their movement during orthodontic treatment.
The direct bonding of orthodontic devices to teeth has had a profound impact on orthodontic practices. In the early days of orthodontic treatment, brackets were attached to gold or stainless-steel bands. This process was time-consuming and uncomfortable for patients, often causing gingival trauma and decalcification. In the mid-1960s, researchers pioneered the bonding of brackets directly to enamel. Since then, there have been numerous advancements in adhesives, base designs, bracket materials, curing methods, primers, fluoride-releasing agents, and sealants. Nevertheless, the incidence and severity of white spot lesions caused by enamel decalcification are increasing among those receiving orthodontic treatment. Surprisingly, these lesions can appear as early as one month after the placement of orthodontic brackets. Prolonged treatment, lasting over a year, increases this risk due to the presence of fixed appliances, creating areas for plaque accumulation. This plaque may rapidly modify the composition of bacteria, particularly acid-producing bacteria, leading to enamel erosion and the formation of white spot lesions (WSLs).
White spot lesions are rapidly forming, prompting clinicians to explore solutions for orthodontic-associated demineralization. Factors such as food debris, diet, fluoride availability, mineral crystal composition, and salivary content can influence demineralization periods. Studies have shown that preventive strategies, such as application of topical fluorides, reduce the incidence of WSLs formation. A systematic review has demonstrated the effectiveness of topical sodium fluoride varnishes (FV) in preventing enamel decalcification during orthodontic treatment with fixed appliances. However, the reported preventive fraction is wide, ranging from 12 to 55%. This shows that the preventive effects of FV are not consistent and vary between individuals. The range of results seen may also be attributed to the bioavailability of fluoride in saliva, which is regulated by variables including salivary secretion rate, dietary fluoride consumption, and the usage of fluoridated products. While traditional fluorides like sodium fluoride support remineralization following topical application, they exhibit shorter persistence in saliva compared to SDF's 38% retention. This is due to the stable silver halide compound that forms in saliva, which helps sustain SDF over an extended period of time, and the high fluoride content of SDF, which renders it a great potential for remineralization. Further, the remineralisation and antibacterial effects of fluoride are slow and highly dependent on factors such as patients brushing efficacy and the stability of the fluoride ion in the saliva. This might explain why the WSLs are still occur and present around the orthodontic brackets even though the preventive measures have been implemented.
Recently, the use of silver diamine fluoride (SDF) has gained much attention in caries management strategy, especially on cavitated lesions. SDF was introduced into the dental field by Nishiino, Yamaga and their colleagues in the 1960s available at 38% concentration. SDF is a colourless and odorless solution which consists of silver, fluoride, and ammonia ion. The presence of the silver component in the SDF formulation helps in stimulating dentine sclerosis and provides antibacterial activity by causing immediate bacterial death through inhibition of bacterial DNA replication and blocking the formation of proteolytic enzymes. Fluoride on the other hand act as a remineralising agent and presents at a high concentration of 44,800 ppm.
The combined effects of remineralising and antibacterial properties make SDF an effective cariostatic agent. A systematic review showed that SDF effectively arrests decay in primary teeth in children, with a proportion of 66%-81% with annual or biannual application, while it was reported that the preventive fraction of SDF is as high as 61% and 72%, respectively. In comparison to fluoride varnish, SDF has a better caries arrest ability on both primary and permanent teeth, where the effectiveness is almost doubled than the effects of sodium fluoride varnish at 30 months.
The only drawback of SDF application is the formation of black staining on the cavitated lesion due to the formation of silver phosphate precipitate when hydroxyapatite crystals react with the SDF solution. However, the addition of potassium iodide managed to reduce the staining effects, leading to a yellow-brown rather than a black discoloration. In addition, SDF will not stain sound enamel suggesting its promising role in the prevention of dental caries.
However, based on our knowledge, the effects of SDF in preventing WSLs formation in patients with fixed orthodontics has not been established yet. Therefore, the investigators would like to take this opportunity and conduct a clinical trial with the aim to investigate the effectiveness of Silver Diamine Fluoride (SDF) in caries prevention among patients with fixed orthodontic appliances.
25 studies on the registry are indexed under Tooth Demineralization; 8 are open to participants now.
This study's planned enrollment of 99 is above the median of 40 across 25 interventional studies indexed under Tooth Demineralization.
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Exclusion Criteria:
Intervention 1 will receive standard OHI (every three months) and application of Silver Diamine Fluoride (SDF (Riva Star, SDI Limited., Australia) every six months.
Drug: Silver diamine fluoride- potassium iodide
Intervention 2 will receive standard OHI (every three months) and application of topical fluoride varnish containing 5% NaF (Duraphat varnish®, Colgate-Palmolive (UK) Ltd) every six months.
Drug: Fluoride varnish
Control will receive standard oral hygiene instructions (OHI every three months) and application of normal saline every six months.
Other: 0.9 % saline
SDF , Riva Star, SDI Limited., Australia
Also known as: Silver Diamine Fluoride
Duraphat varnish®, Colgate-Palmolive (UK) Ltd.
Standard oral hygiene instructions every 3 months and application of Normal Saline for every 6 months
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
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
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
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
Plan to share: Undecided — Data will be submitted to the university repository and final data will be deposited to the university. Patient personal information will be protected and subjected to Data Security Act.
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National University of Malaysia