The use of computerized anesthesia 'QuickSleeper 5' in children undergoing dental treatment

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: This study will compare two types of dental anesthesia in children; the intervention type will QuickSleeper 5 (QS) and the control one will be an active control with an inferior alveolar nerve block (IANB). The study will include 52 participants aged between 7‐9 years and all of them need bilateral pulpotomy for primary mandibular second molars in order to perform the study in a split mouth design. All participants will be allocated equally into two groups; Group 1: starts the first session with QS and the second session with IANB and Group 2: starts the first session with IANB and the second session with QS. A random allocation list will be carried out by using the website: www.randomalist.com, all of the participants will be numbered from 1 ‐ 52 in order to allocate them randomly into the two study groups. After that, each child will pull a closed envelope to determine with which side they will start (right or left). Half of the ampule (0.9 ml) of Lidocaine 2% with epinephrine 1:100,000 will be administered for each child in both types of anesthesia used (IANB and QS) in the QuickSleeper injection, the insertion point will be between the first and second primary molars under the periodontal papilla. CONDITION: Anesthetizing primary molars in children ; Oral Health PRIMARY OUTCOME: ; 1. The effectiveness of both techniques of anesthesia will be studied during the pulp treatment procedure; 2. Pain caused by the anesthesia will be studied using both subjective method (Simplified Faces Pain Scale S‐FPS) immediately after the injection and objective method ( Face – Legs – Activity – Cry – Consolability scale FLACC) during the injection; 3. Local complications of anesthesia will be studied at baseline, 24h, 48h and 1 week; SECONDARY OUTCOME: Parental satisfaction will be studied after 1 week measured using a bespoke questionnaire INCLUSION CRITERIA: 1. Healthy children who don't suffer from any systemic disease 2. Children aged between 6 ‐ 9 years 3. Children who need bilateral pulpotomy for mandibular second primary molars 4. Cooperative children who are classified as definitely positive according to Frankel
Epistemonikos ID: ac681836b216a5a21f13c77798b2714190b95591
First added on: Aug 25, 2024