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

NCT06293547 | Completed

• 1 other identifier: DIS-2022-295
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caries, silver daimine fluoride, primary teeth

Outcome Measures

Primary Outcomes (1)

• Clinical Assessment of Arrested Caries Lesions

  The primary outcome was evaluating the efficacy of SDF treatment in arresting active carious lesions. This assessment was conducted through clinical examinations of the patients.

  6 month

Secondary Outcomes (1)

• Parental acceptance of SDF treatment

  6 month

Study Arms (1)

Single arm

EXPERIMENTAL

Following a standard dental examination, which may have included intraoral radiographs as needed, the application of 38% SDF (Riva Star, SDI Australia) was conducted on carious lesions identified in primary teeth. The application procedure of SDF adhered to the protocol recommended in the literature and the instructions provided by the manufacturer. One and experienced researcher applied SDF to each patient. Initially, the affected teeth were isolated and dried using gauze and cotton rolls. Subsequently, the SDF solution was applied directly to the lesions using a microbrush, with an absorption time ranging from a minimum of 30 seconds to a maximum of 120 seconds, depending on the child's behavior (30-60-90-120 seconds). Any excess solution was carefully removed using gauze. Parents were instructed to ensure that the child refrained from eating or drinking for at least one hour following the application of SDF.

Drug: Silver Diamine Fluoride

Interventions

Silver Diamine Fluoride DRUG

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.

Also known as: SDF

Single arm

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Interventions

silver diamine fluoride

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatric Dentistry

Model Details: The study group of this non-randomized, prospective, single-arm clinical research consisted of pediatric patients and their parents who presented to the Department of Pediatric Dentistry, Faculty of Dentistry, Cumhuriyet University, selected using convenient sampling method. For determining the sample size in this study, assuming a 5% alpha error, 80% power, and a cessation rate (35.7%) from a previous study, it was calculated that at least 40 participants should be included. Considering potential patient loss/follow-up, the study group was increased by 20%, resulting in a final decision to include 48 children and their parents in the study.

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: August 10, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)