Preventive Effects of Silver Diamine Fluoride on Early Enamel Caries

NCT06797882 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: JEP-2024-878
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Demineralization, Tooth; White Spot Lesion of Tooth; Fixed Appliances; Early Caries Lesions

Keywords

Early Caries Lesions; Silver Diamine Fluoride (SDF); Fixed Orthodontic Appliances; Caries Prevention; Fluoride Varnish; White Spot Lesions

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  12 months

Study Arms (3)

Standard of care + Silver Diamine Fluoride (SDF)

EXPERIMENTAL

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

Standard of care + Fluoride varnish

ACTIVE COMPARATOR

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

Standard of care + Normal Saline

PLACEBO COMPARATOR

Control will receive standard oral hygiene instructions (OHI every three months) and application of normal saline every six months.

Other: 0.9 % saline

Interventions

Silver diamine fluoride- potassium iodide DRUG

SDF , Riva Star, SDI Limited., Australia

Also known as: Silver Diamine Fluoride

Standard of care + Silver Diamine Fluoride (SDF)

Fluoride varnish DRUG

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

Standard of care + Fluoride varnish

0.9 % saline OTHER

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

Standard of care + Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients undergoing orthodontic treatment with conventional orthodontic brackets placed on the labial surface.
• Any degree of malocclusion
• Fit and healthy patient
• Non-smoker
• Subjects can understand and possessed basic command in English

You may not qualify if:

• 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
• Presence of untreated cavitated lesions, especially on upper and lower incisors and canines
• Plaque levels \>30%.
• Patient allergic to any of the content of the intervention material (sodium fluoride, silver diamine fluoride, potassium iodide).
• Patients with lingual brackets.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Faculty of Dentistry, UKM

Kuala Lumpur, Kuala Lumpur, 50300, Malaysia

Location

Related Publications (21)

• Mungur A, Chen H, Shahid S, Baysan A. A systematic review on the effect of silver diamine fluoride for management of dental caries in permanent teeth. Clin Exp Dent Res. 2023 Apr;9(2):375-387. doi: 10.1002/cre2.716. Epub 2023 Feb 23.

  PMID: 36823765 BACKGROUND

• Lussi A, Megert B, Longbottom C, Reich E, Francescut P. Clinical performance of a laser fluorescence device for detection of occlusal caries lesions. Eur J Oral Sci. 2001 Feb;109(1):14-9. doi: 10.1034/j.1600-0722.2001.109001014.x.

  PMID: 11330928 BACKGROUND

• Lazar L, Vlasa A, Beresescu L, Bud A, Lazar AP, Matei L, Bud E. White Spot Lesions (WSLs)-Post-Orthodontic Occurrence, Management and Treatment Alternatives: A Narrative Review. J Clin Med. 2023 Feb 28;12(5):1908. doi: 10.3390/jcm12051908.

  PMID: 36902696 BACKGROUND

• Jabin Z, Nasim I, Priya V V, Agarwal N. Comparative Evaluation of Salivary Fluoride Concentration after Topical Application of Silver Diamine Fluoride and Sodium Fluoride: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2022 May-Jun;15(3):371-375. doi: 10.5005/jp-journals-10005-2398.

  PMID: 35991787 BACKGROUND

• Hicks J, Garcia-Godoy F, Flaitz C. Biological factors in dental caries: role of remineralization and fluoride in the dynamic process of demineralization and remineralization (part 3). J Clin Pediatr Dent. 2004 Spring;28(3):203-14. doi: 10.17796/jcpd.28.3.w0610427l746j34n.

  PMID: 15163148 BACKGROUND

• Gange P. The evolution of bonding in orthodontics. Am J Orthod Dentofacial Orthop. 2015 Apr;147(4 Suppl):S56-63. doi: 10.1016/j.ajodo.2015.01.011.

  PMID: 25836345 BACKGROUND

• Seifo N, Robertson M, MacLean J, Blain K, Grosse S, Milne R, Seeballuck C, Innes N. The use of silver diamine fluoride (SDF) in dental practice. Br Dent J. 2020 Jan;228(2):75-81. doi: 10.1038/s41415-020-1203-9.

  PMID: 31980777 BACKGROUND

• Tufekci E, Dixon JS, Gunsolley JC, Lindauer SJ. Prevalence of white spot lesions during orthodontic treatment with fixed appliances. Angle Orthod. 2011 Mar;81(2):206-10. doi: 10.2319/051710-262.1.

  PMID: 21208070 BACKGROUND

• Sonesson M, Twetman S. Prevention of white spot lesions with fluoride varnish during orthodontic treatment with fixed appliances: a systematic review. Eur J Orthod. 2023 Sep 18;45(5):485-490. doi: 10.1093/ejo/cjad013.

  PMID: 37032523 BACKGROUND

• Sardana D, Ekambaram M, Yang Y, McGrath CP, Yiu CKY. Caries-preventive effectiveness of two different fluoride varnishes: A randomised clinical trial in patients with multi-bracketed fixed orthodontic appliances. Int J Paediatr Dent. 2023 Jan;33(1):50-62. doi: 10.1111/ipd.13013. Epub 2022 Jul 10.

  PMID: 35737872 BACKGROUND

• Sardana D, Li KY, Ekambaram M, Yang Y, McGrath CP, Yiu CK. Validation of clinical photography and a laser fluorescence device for assessment of enamel demineralization during multi-bracketed fixed orthodontic treatment. Photodiagnosis Photodyn Ther. 2022 Jun;38:102828. doi: 10.1016/j.pdpdt.2022.102828. Epub 2022 Mar 23.

  PMID: 35339722 BACKGROUND

• Kidd E, Fejerskov O. Changing concepts in cariology: forty years on. Dent Update. 2013 May;40(4):277-8, 280-2, 285-6. doi: 10.12968/denu.2013.40.4.277.

  PMID: 23829008 BACKGROUND

• Jiang H, Hua F, Yao L, Tai B, Du M. Effect of 1.23% acidulated phosphate fluoride foam on white spot lesions in orthodontic patients: a randomized trial. Pediatr Dent. 2013 May-Jun;35(3):275-8.

  PMID: 23756315 BACKGROUND

• Ismail AI, Sohn W, Tellez M, Amaya A, Sen A, Hasson H, Pitts NB. The International Caries Detection and Assessment System (ICDAS): an integrated system for measuring dental caries. Community Dent Oral Epidemiol. 2007 Jun;35(3):170-8. doi: 10.1111/j.1600-0528.2007.00347.x.

  PMID: 17518963 BACKGROUND

• Horst JA, Heima M. Prevention of Dental Caries by Silver Diamine Fluoride. Compend Contin Educ Dent. 2019 Mar;40(3):158-163; quiz 164.

  PMID: 30829497 BACKGROUND

• Gorelick L, Geiger AM, Gwinnett AJ. Incidence of white spot formation after bonding and banding. Am J Orthod. 1982 Feb;81(2):93-8. doi: 10.1016/0002-9416(82)90032-x.

  PMID: 6758594 BACKGROUND

• Duangthip D, Fung MHT, Wong MCM, Chu CH, Lo ECM. Adverse Effects of Silver Diamine Fluoride Treatment among Preschool Children. J Dent Res. 2018 Apr;97(4):395-401. doi: 10.1177/0022034517746678. Epub 2017 Dec 13.

  PMID: 29237131 BACKGROUND

• Chu CH, Lo EC, Lin HC. Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children. J Dent Res. 2002 Nov;81(11):767-70. doi: 10.1177/0810767.

  PMID: 12407092 BACKGROUND

• Camacho KJ, English JD, Jacob HB, Harris LM, Kasper FK, Bussa HI, Quock RL. Silver diamine fluoride and bond strength to enamel in vitro: A pilot study. Am J Dent. 2018 Dec;31(6):317-319.

  PMID: 30658379 BACKGROUND

• Bishara SE, Gordan VV, VonWald L, Jakobsen JR. Shear bond strength of composite, glass ionomer, and acidic primer adhesive systems. Am J Orthod Dentofacial Orthop. 1999 Jan;115(1):24-8. doi: 10.1016/s0889-5406(99)70312-4.

  PMID: 9878954 BACKGROUND

• Crystal YO, Janal MN, Hamilton DS, Niederman R. Parental perceptions and acceptance of silver diamine fluoride staining. J Am Dent Assoc. 2017 Jul;148(7):510-518.e4. doi: 10.1016/j.adaj.2017.03.013. Epub 2017 Apr 27.

  PMID: 28457477 BACKGROUND

MeSH Terms

Conditions

Tooth Demineralization

Interventions

silver diamine fluoride; Sodium Chloride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ahmad Shuhud Irfani Zakaria, MClinDent

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhd Ja'afar Siddique Mohd Hafizan, BDMS

CONTACT

+60136408105; p153628@siswa.ukm.edu.my

Ahmad Shuhud Irfani Zakaria, MClinDent

CONTACT

+6012-6137206; shuhud_zakaria@ukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A total of 99 eligible participants will be randomly assigned to three intervention groups-SDF, FV (gold standard), or normal saline (placebo)-with 33 participants per group. Randomization will be conducted using Microsoft Excel by a data manager, who is not blinded and will ensure proper group allocation. Participants will be blinded to their assigned intervention, which will be provided in a concealed opaque envelope. The care provider, however, will not be blinded due to the distinct characteristics of each material. Follow-up assessments will occur at 1, 3, 6, and 12 months. At each visit, a blinded outcome assessor will evaluate the upper incisors using the ICDAS II scoring system and DIAGNOdent after prophylactic cleaning. Additionally, digital photographs will be assessed using the Gorelick scoring system by blinded outcome assessors on a separate occasion.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study follows a randomized controlled trial design with three parallel groups. Each participant, rather than specific areas within the mouth, will be the unit of randomization. This method, in contrast to a split-mouth design, helps prevent issues related to cross-contamination.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 29, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2025

Record last verified: 2025-01

Locations

MY (1)