protocolSection identificationModule nctId: NCT06293547, orgStudyIdInfo id: DIS-2022-295, briefTitle: Clinical Effectiveness and Parental Acceptance of Silver Diamine Fluoride in Preschool Children: A Non-randomized Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-08-10, primaryCompletionDateStruct date: 2023-10-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Cumhuriyet University, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Silver Diamine Fluoride, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 48, type: ACTUAL, armsInterventionsModule interventions name: Silver Diamine Fluoride, outcomesModule primaryOutcomes measure: Clinical Assessment of Arrested Caries Lesions, secondaryOutcomes measure: Parental acceptance of SDF treatment, eligibilityModule sex: ALL, minimumAge: 3 Years, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sivas Cumhuriyet University, city: Sivas, state: Merkez, country: Turkey, geoPoint lat: 39.74833, lon: 37.01611, hasResults: False