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Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial

NCT06293547 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-03-05

No results posted yet for this study

Summary

Silver diamine fluoride (SDF) is a topical fluoride agent that has emerged in recent years and has a strong potential to arrest dentinal caries in early childhood caries. SDF has been developed as an effective non-invasive treatment method, especially in the non-cooperative preschool group, with its advantages such as easy application, low cost, and limited technical difficulties. The aims of this study were as follow: (a) to evaluate the efficacy of 38% GDF in arresting active dental caries lesions and reducing or preventing associated dental pain and infections in at-risk young children; and (b) how SDF treatment is perceived and acceptable by parents. The null hypothesis of the study was that 38% SDF treatment will be effective in arresting active dental caries lesions and reducing the incidence of pain and infection in young children, and is well-accepted by parents. The study group of this clinical research will consist of pediatric patients and their parents who were selected by easily accessible case sampling method and applied to Sivas Cumhuriyet University Faculty of Dentistry Pediatric Dentistry clinic. The working group will consist of a total of 48 children and their parents who meet the inclusion criteria. Parents will also be briefed on the GDF, follow-up instructions, oral hygiene instructions, and dietary education. After a baseline examination including radiographs taken during a standard dental examination, 38% GDF will be applied to carious lesions detected in primary teeth. Carious lesions will be treated with 38% SDF application once or twice. Children will be reassessed at 3-week, 3-month and 6-month follow-up sessions to assess color and structural changes in carious lesions (soft/hard). Parents will be asked to answer a questionnaire including questions about pain or infection symptoms and their views on SDF treatment.

Conditions

  • Silver Diamine Fluoride

Interventions

DRUG

Silver Diamine Fluoride

Silber Diamine Fluoride, a colorless, odorless alkaline solution, effectively halts carious lesions in various populations, including children and elderly patients, or those averse to invasive treatments. Its high fluoride content facilitates remineralization, caries arrest, and prevention. SDF application is simple, non-invasive, cost-effective, and does not stain intact enamel, making it suitable for treating dentin hypersensitivity. Its ease of use is advantageous for children, patients with special needs, and the elderly. Particularly beneficial for high-risk patients with salivary dysfunction or multiple carious lesions, SDF offers potential in pediatric dentistry and community oral health by streamlining procedures, requiring rapid application without sharp instruments or anesthesia.

Sponsors & Collaborators

  • Cumhuriyet University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-10
Primary Completion
2023-10-30
Completion
2023-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06293547 on ClinicalTrials.gov