SDF Effectiveness on Arresting Caries in Children

NCT05872542 | Recruiting Phase 4 FDA Drug

• 1 other identifier: HAPO-02-K-012-2021-11-844
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To assess the clinical effectiveness of silver diamine fluoride (SDF) to control asymptomatic cavitated carious lesions compared to conventional glass ionomer restoration in preschool children.

Conditions

Dental Caries in Children

Keywords

Silver diamine fluoride; Arrested caries; Deciduous teeth

Outcome Measures

Primary Outcomes (4)

• Mean Change from Baseline in Dental Caries Lesions using ICDAS score at Week 24

  The International Caries Detection and Assessment System (ICDAS) is a validated instrument that measures the surface changes of carious lesions by relying on surface characteristics. The ICDAS detection codes for coronal caries range from 0 to 6 depending on the severity of the lesion; code 0: sound tooth surface, code 1:white brown opacity affecting pit or fissure, code 2:distinct changes detected in wet-enamel, code 3: localized enamel breakdown, code 4: underlying dark shadow from dentine, code 5: distinct cavity in dentine, code 6: distinct cavity (more than half surface) in dentine.

  Baseline and Week 24

• Mean Change from Baseline in Dental Caries Lesions using dmfs index at Week 24

  The dmfs index is a validated tool that is used to assess the extent of dental caries experience affecting deciduous dentition where "d" stands for decayed, "m" stands for missing tooth due to caries, and "f" stands for filled tooth due to caries.

  Baseline and Week 24

• Change from Baseline in Dental Caries Activity using Arrested or Active caries characteristics at Week 24

  Changing of affected carious lesion texture and color; from soft, rough yellow or brown lesion(active caries), to hard smooth dark brown to black color(arrested caries).

  Baseline and Week 24

• Mean Change from Baseline in Dental Caries Susceptibility using the CariScreen Caries Susceptibility Testing meter at Week 24

  CariScreen meter is a validated tool that measures adenosine triphosphate-driven bioluminescence for quantification of plaque bacteria to determine if the participant is at low risk (from 0- to 1500 RLUs) or at risk (from1501- to 9999 RLUs) of developing dental caries.

  Baseline and Week 24

Secondary Outcomes (3)

• Mean Change from Baseline in oral health status using the Plaque index score at Week 24.

  Baseline and Week 24

• Mean Change from Baseline in oral health status using the Gingival index score at Week 24.

  Baseline and Week 24

• Mean Change from Baseline in saliva pH using pH meter at Week 24.

  Baseline and Week 24

Study Arms (3)

Silver Diamine Fluoride (SDF)

EXPERIMENTAL

SDF will be applied once to affected carious teeth surfaces at the end of the first visit. Under proper isolation, only gross debris will be removed and SDF will be applied directly to the carious lesion using micro brush according to the manufacturer's instructions.

Drug: Silver Diamine Fluoride (SDF)

Glass ionomer restoration (GI)

ACTIVE COMPARATOR

GI will be applied to carious lesions following the manufacturer's instructions.

Other: Glass Ionomer Restoration (GI)

Sodium Fluoride varnish with silver nano-particles (NaF-AgNP)

ACTIVE COMPARATOR

NaF-AgNP will be applied once to affected carious teeth surfaces at the end of the first visit. Under proper isolation, only gross debris will be removed and NaF-AgNP will be applied directly to the carious lesion using micro brush according to the manufacturer's instructions.

Other: Sodium fluoride varnish with nano-sliver particles (NaF-AgNP)

Interventions

Silver Diamine Fluoride (SDF) DRUG

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply SDF to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Remove excess SDF with gauze or cotton pellets. Continue to isolate the site for up to three minutes.

Silver Diamine Fluoride (SDF)

Glass Ionomer Restoration (GI) OTHER

Application of GI restoration necessitates removal of carious tissue using round bur rotating on low-speed contra and excavation of infected carious dentin. Followed by restoring the prepared cavity with glass ionomer restoration according to the manufacturer's instructions. The restoration will be checked for any high spots and occlusal interference (if any) will be corrected.

Glass ionomer restoration (GI)

Sodium fluoride varnish with nano-sliver particles (NaF-AgNP) OTHER

Proper isolation of the operating field and removal of gross debris. Minimize contact with the gingiva and mucus membrane. Gentle dryness with compressed air. Dip and dab micro brush on the side of the dapper dish. Apply NaF-AGNP to the affected surface (one drop/ appointment). Gentle dryness with compressed air for one minute. Continue to isolate the site for up to three minutes.

Sodium Fluoride varnish with silver nano-particles (NaF-AgNP)

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children without a history of serious systemic conditions necessitating chronic use of medications.
• Children whose dental examination reveals at least one untreated asymptomatic cavitated carious lesion (ICDAS index: code 3-5) affecting primary molars.
• Absence of former history of spontaneous pain from the offending tooth/teeth.
• Teeth with normal vital pulp response when assessed using sensibility test and absence of any signs of irreversible pulpitis or necrotic pulp degeneration.
• Absence of abnormal grade of tooth mobility, swelling, or tenderness on palpation or percussion.
• Absence of any evidence of peri-radicular pathosis, or internal- or external resorption on radiographic examination.

You may not qualify if:

• Patients with proven allergy to silver compounds or any component of dental materials to be applied.
• Patients or guardians who refuse to participate in the study or had poor acceptance of SDF treatment.
• Patients with ulcerative gingivitis or stomatitis.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

UmmAlQuraUniversity

Mecca, Saudi Arabia

RECRUITING

Related Publications (16)

• Al-Halabi M, Salami A, Alnuaimi E, Kowash M, Hussein I. Assessment of paediatric dental guidelines and caries management alternatives in the post COVID-19 period. A critical review and clinical recommendations. Eur Arch Paediatr Dent. 2020 Oct;21(5):543-556. doi: 10.1007/s40368-020-00547-5. Epub 2020 Jun 16.

  PMID: 32557183 BACKGROUND

• Brian Z, Weintraub JA. Oral Health and COVID-19: Increasing the Need for Prevention and Access. Prev Chronic Dis. 2020 Aug 13;17:E82. doi: 10.5888/pcd17.200266.

  PMID: 32790606 BACKGROUND

• BaniHani A, Gardener C, Raggio DP, Santamaria RM, Albadri S. Could COVID-19 change the way we manage caries in primary teeth? Current implications on Paediatric Dentistry. Int J Paediatr Dent. 2020 Sep;30(5):523-525. doi: 10.1111/ipd.12690. No abstract available.

  PMID: 32722881 BACKGROUND

• Blumer S, Costa L, Peretz B. Success of Dental Treatments under Behavior Management, Sedation and General Anesthesia. J Clin Pediatr Dent. 2017;41(4):308-311. doi: 10.17796/1053-4628-41.4.308.

  PMID: 28650778 BACKGROUND

• Mabangkhru S, Duangthip D, Chu CH, Phonghanyudh A, Jirarattanasopha V. A randomized clinical trial to arrest dentin caries in young children using silver diamine fluoride. J Dent. 2020 Aug;99:103375. doi: 10.1016/j.jdent.2020.103375. Epub 2020 May 16.

  PMID: 32428523 BACKGROUND

• Raskin SE, Tranby EP, Ludwig S, Okunev I, Frantsve-Hawley J, Boynes S. Survival of silver diamine fluoride among patients treated in community dental clinics: a naturalistic study. BMC Oral Health. 2021 Jan 20;21(1):35. doi: 10.1186/s12903-020-01379-x.

  PMID: 33472613 BACKGROUND

• Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Randomized Clinical Trial of 12% and 38% Silver Diamine Fluoride Treatment. J Dent Res. 2018 Feb;97(2):171-178. doi: 10.1177/0022034517728496. Epub 2017 Aug 28.

  PMID: 28846469 BACKGROUND

• Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3.

  PMID: 22484380 BACKGROUND

• Mei ML, Ito L, Cao Y, Li QL, Lo EC, Chu CH. Inhibitory effect of silver diamine fluoride on dentine demineralisation and collagen degradation. J Dent. 2013 Sep;41(9):809-17. doi: 10.1016/j.jdent.2013.06.009. Epub 2013 Jun 27.

  PMID: 23810851 BACKGROUND

• Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries "silver-fluoride bullet". J Dent Res. 2009 Feb;88(2):116-25. doi: 10.1177/0022034508329406.

  PMID: 19278981 BACKGROUND

• Wakshlak RB, Pedahzur R, Avnir D. Antibacterial activity of silver-killed bacteria: the "zombies" effect. Sci Rep. 2015 Apr 23;5:9555. doi: 10.1038/srep09555.

  PMID: 25906433 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

• Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012 Nov;40(11):962-7. doi: 10.1016/j.jdent.2012.08.002. Epub 2012 Aug 11.

  PMID: 22892463 BACKGROUND

• Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.

  PMID: 16040729 BACKGROUND

• Young DA, Novy BB, Zeller GG, Hale R, Hart TC, Truelove EL; American Dental Association Council on Scientific Affairs; American Dental Association Council on Scientific Affairs. The American Dental Association Caries Classification System for clinical practice: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2015 Feb;146(2):79-86. doi: 10.1016/j.adaj.2014.11.018.

  PMID: 25637205 BACKGROUND

• Ekstrand KR, Zero DT, Martignon S, Pitts NB. Lesion activity assessment. Monogr Oral Sci. 2009;21:63-90. doi: 10.1159/000224213. Epub 2009 Jun 3.

  PMID: 19494676 BACKGROUND

MeSH Terms

Interventions

silver diamine fluoride

Study Officials

• Abla Arafa

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abla Arafa

CONTACT

+966543869336; ablaarafa@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

SA (1)