Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT07268157
Brief Summary:
In children with molar-incisor hypomineralization (MIH), insufficient depth of anesthesia can lead to increased anxiety and behavior management problems, which may negatively affect the quality of restorations. This situation has increased the need for modern techniques and devices to minimize pain during local anesthesia. The aim of this study was to compare the effects of the SleeperOne computer-controlled local anesthesia system and the conventional local anesthesia technique on pain and anxiety in children with MIH. The null hypothesis of the study stated that there would be no statistically significant difference between the effects of the two local anesthesia methods on pain and anxiety in children with MIH.
Detailed Description:
The study was conducted using a split-mouth design with 28 patients and 56 teeth who met the inclusion criteria and were recruited from the Department of Pediatric Dentistry, Faculty of Dentistry, Tokat Gaziosmanpaşa University. The patients included in the study were randomly assigned to two groups:
* Control group: Anesthesia administered using the conventional injection technique.
* Study group: Intraosseous anesthesia administered with the computer-controlled anesthesia device (SleeperOne).
Teeth affected by MIH were classified according to the Molar-Incisor Hypomineralization Treatment Need Index (MIH-TNI). Those in category 2 were evaluated as "Without hypersensitivity," while those in category 4 were assessed as "With hypersensitivity" Prior to the study, all participants completed the Children's Fear Survey Schedule-Dental Subscale (CFSS-DS). Pulse rate, oxygen saturation (SpO₂), and salivary cortisol levels were measured before local anesthesia, after anesthesia, and after treatment. In addition, the Wong-Baker FACES Pain Rating Scale (WBS), Visual Analogue Scale (VAS), and Face, Legs, Activity, Cry, Consolability Scale (FLACC) were used. The data were analyzed statistically.
Study:
NCT07268157
Study Brief:
Protocol Section:
NCT07268157