SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction
NCT ID: NCT07156396
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
28 participants
INTERVENTIONAL
2025-09-02
2025-09-02
Brief Summary
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Children between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned.
Pain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded.
This study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience.
The study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.
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Detailed Description
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A total of 28 healthy children aged 3 to 5 years, requiring extraction of at least one mandibular primary molar, will be enrolled and randomly assigned into two parallel groups: the intervention group (SleeperOne®) and the control group (conventional syringe). Both groups will receive the same anesthetic solution: 3% Mepivacaine without vasoconstrictor. Topical anesthesia will be applied using 20% benzocaine gel before injection in all participants.
Pain management during dental treatment in children is a major concern in pediatric dentistry. Traditional infiltration anesthesia using a syringe is effective but often associated with pain, anxiety, and fear, which can negatively affect child cooperation. Computer-controlled local anesthetic delivery (CCLAD) systems, such as the SleeperOne® 5, have been developed to minimize these issues by providing a slow and steady flow of anesthesia with improved ergonomics for the operator.
This randomized clinical trial will compare pain perception during maxillary primary molar extraction in children using the SleeperOne® 5 device versus conventional infiltration with a standard dental syringe. The trial will follow a parallel design with two arms: an intervention group receiving local anesthesia via the SleeperOne® 5, and a control group receiving conventional syringe infiltration.
Participants will be children aged 3-5 years who require extraction of a maxillary primary molar. Topical anesthesia with benzocaine will be applied prior to injection in both groups. Local infiltration will then be administered using either the SleeperOne® 5 or a conventional syringe, depending on group allocation.
The primary outcome is pain perception during injection and extraction, measured subjectively using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and objectively using the Sound, Eye, and Motor (SEM) scale by an independent, blinded evaluator. Secondary outcomes include patient anxiety, recorded using the Modified Child Dental Anxiety Scale (MCDAS), and physiological responses (heart rate and blood pressure) measured with a digital monitor.
The study is designed with two parallel groups, with an anticipated sample size of 28 children (14 per group), based on a power calculation. Randomization will be performed using a computer-generated list. Blinding of participants is not possible due to the nature of the interventions, but outcome assessment will be blinded.
The results of this study are expected to provide clinical evidence on whether CCLAD (SleeperOne® 5) offers a significant advantage over conventional infiltration in reducing pain and anxiety during pediatric dental extractions.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Conventional Infiltration
Children will receive 3% mepivacaine with conventional syringe after 20% benzocaine
Conventional Infiltration
Local anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.
SleeperOne® Device
Children will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine.
SleeperOne®, dental Hitec, France
SleeperOne® is a computerized local anesthetic delivery system used to deliver 3% mepivacaine following application of 20% benzocaine topical gel. It is designed to reduce injection pain and improve comfort during pediatric dental procedures.
Interventions
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SleeperOne®, dental Hitec, France
SleeperOne® is a computerized local anesthetic delivery system used to deliver 3% mepivacaine following application of 20% benzocaine topical gel. It is designed to reduce injection pain and improve comfort during pediatric dental procedures.
Conventional Infiltration
Local anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.
Eligibility Criteria
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Inclusion Criteria
* Medically fit children classified as ASA physical status I and II
* Parents acceptance to participate in the study (informed consent)
* Children with teeth diagnostically confirmed to require extraction
Exclusion Criteria
* Uncooperative children
* Children requiring general anesthesia
3 Years
5 Years
ALL
No
Sponsors
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Ameera Alaa Eldin Abdalazim Khalifa
OTHER
Responsible Party
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Ameera Alaa Eldin Abdalazim Khalifa
MSc Candidate in Pediatric Dentistry, Faculty of Dentistry, Cairo University
Central Contacts
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Study Documents
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Document Type: Informed Consent Form
Study protocol will be uploaded and publicly accessible upon final approval.
View DocumentRelated Links
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it introduces the sleeper one 5 anesthetic device
Other Identifiers
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832025
Identifier Type: -
Identifier Source: org_study_id
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