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

Ethical Approval Clinical examination and data collection procedures were conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Cumhuriyet University, following ethical approval from the Clinical Research and Ethics Committee of Sivas Cumhuriyet University Medical Faculty on June 14, 2022 (Approval No: 2022-06/04). All parents or legal guardians of the children participating in the study were provided with information about the study prior to the procedures, and signed informed consent forms were obtained.

Research Design 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. The CONSORT (Consolidated Standards of Reporting Trials) flow diagram showing the research design and protocol is depicted in Figure 1.

Inclusion and Exclusion Criteria The inclusion criteria for the study were as follows: voluntary participation, mentally and physically healthy children aged 3-5 years, and mentally and physically healthy parents with native literacy. Children having at least one carious lesion identified according to International Caries Detection and Assessment System (ICDAS) criteria to be included in the study. Lesions classified using the ICDAS scale are as follows: active (soft) cavitated carious lesions extending into dentine during primary dentition (ICDAS 5 or 6); non-cavitated lesions (ICDAS 3 or 4); or initial carious lesions (ICDAS 1 or 2). Those with ICDAS scores of 3, 4, 5, and 6 were included in the study. The exclusion criteria for the current study were as follows: small interproximal caries not clinically observable; children showing signs of spontaneous pain, tooth mobility, or pulp infection due to caries; medical issues preventing treatment in the clinic, congenital developmental defects, allergies or sensitivities to SDF, and non-cooperation or failure to attend follow-up visits.

SDF Applicaiton Informed consent was obtained from the parents or legal guardians of the children participating in the study. Additionally, detailed information SDF treatment, follow-up instructions, oral hygiene guidelines, and dietary education was provided to the parents. 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.

The isolation of the lesion is vital component of the protocol, ensuring the efficacy of SDF in arresting the progression of the lesion. Therefore, children were scheduled for follow-up appointments at 3 weeks, 3 months and 6 months (recall visits) to assess the status of the lesions. If the carious lesions did not exhibit characteristics of being black and hard at both recall appointments, indicating non-progression, a second application of SDF was administered.