Comparison of Pain Perception in A Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using A Novel Anesthetic Device Versus Traditional Infiltration

Official title

Comparison of Pain Perception in a Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using a Novel Anesthetic Device Versus Conventional Infiltration: A Randomized Controlled Trial

Overview

This study aims to compare the pain felt by children during tooth extraction using two different techniques for giving local anesthesia. One group of children will receive anesthesia using a modern electronic device called SleeperOne® 5, which controls the flow and pressure of the anesthesia to reduce pain. The other group will receive anesthesia using the traditional syringe method, which is more commonly used in dental clinics. The study will include children between the ages of 3 and 5 years old who need to have an upper baby molar tooth extracted. All children in the study will be healthy (classified as ASA I or II), and their parents must agree to participate. During the procedure, each child will first receive a topical anesthetic gel to numb the surface. Then, based on random selection, the child will receive local anesthesia using either the SleeperOne® 5 device or the traditional syringe. Pain levels during the injection and during the extraction will be measured using special scales suitable for children. Other factors like how long the anesthesia takes to work and how long it lasts will also be recorded. This research will help dentists understand whether the SleeperOne® 5 device offers a more comfortable experience for young children compared to the traditional method. The goal is to reduce fear and pain during dental treatments for kids.

Detailed description

This randomized controlled clinical trial is designed to evaluate and compare the pain perception in pediatric patients during maxillary primary molar extraction when local anesthesia is administered using either the SleeperOne® 5 electronic delivery system or the conventional infiltration technique with a standard syringe.

Participants will be healthy children aged 3 to 5 years, classified as ASA I or ASA II, requiring extraction of a maxillary primary molar. After obtaining informed consent from the parent or guardian, eligible participants will be randomly assigned to one of two groups using a sealed-envelope technique.

Both groups will receive topical anesthesia prior to local injection. In the control group, local anesthesia will be administered using a traditional 30-gauge dental needle and syringe. In the intervention group, anesthesia will be delivered using the SleeperOne® 5 device, which offers controlled flow and pressure to minimize discomfort.

Pain during injection and during extraction will be evaluated using both subjective and objective pain assessment tools: the Wong-Baker Faces Pain Rating Scale (WBFPR) and the Sound, Eye, Motor (SEM) scale. Secondary outcomes will include time of anesthetic onset and duration, as well as any post-operative complications such as soft tissue trauma or ulceration.

All procedures will be performed by the same pediatric dentist to ensure consistency, and the clinical environment will follow standard infection control protocols. This study aims to determine whether the use of a computer-assisted anesthesia system provides superior comfort and patient experience compared to conventional methods in young children undergoing dental extractions.

Interventions

• Device SleeperOne 5
  A computerized local anesthetic delivery system (manufactured by Dental Hi-Tec, France) designed to minimize pain perception in children during dental procedures by controlling the pressure and flow rate of anesthetic injection. It will be used to deliver 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals, Egypt) during maxillary primary molar extraction in pediatric patients.
• Procedure (Conventional Infiltration Anesthesia)
  Local anesthetic solution (3% mepivacaine with no vasoconstrictor), manufactured by Alexandria Co. for Pharmaceuticals, Egypt. It will be administered using a 30-gauge short dental needle and standard dental syringe for conventional infiltration anesthesia during primary maxillary molar extraction in pediatric patients.

Primary outcome measures

• Pain perception during local anesthetic injection [Time frame: during local anesthetic injection (within 1-2 minutes)]

Secondary outcome measures (4)

• Effectiveness: Onset and recovery time of local anesthesia [Time frame: During and immediately after the procedure (Reference: Saoji et al., 2019)]
• Duration of the procedure (injecting the anesthesia) [Time frame: During the procedure (Reference: Saoji et al., 2019)]
• Incidence of postoperative ulcers [Time frame: 24 hrs follow up]
• Pain experienced during extraction [Time frame: During tooth extraction (Reference: Dhake et al., 2022)]

Eligibility criteria

• Inclusion criteria:

• Children aged 3-5 years old
• Medically fit children classified as ASA physical status I and II
• Parents acceptance to participate in the study (informed consent)
• Pediatric patients having teeth that have been diagnostically confirmed as requiring extraction.

Exclusion criteria

• Uncooperative children.
• Patients with an allergy to local anesthesia.
• Children in need of treatment under general anesthesia.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07124052 · 8820255

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗