Dental AnxietySOTIMANNCT07156396
SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction
A study testing SleeperOne®, dental Hitec, France and Conventional Infiltration in people with Dental Anxiety and Pain, run by Ameera Alaa Eldin Abdalazim Khalifa.
Trial summary
This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Dental Anxiety, Pain, Pain Management
- What is being tested?
- SleeperOne®, dental Hitec, France and Conventional Infiltration
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2025to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children Aged between 3 to 5 years.
- 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
Who cannot join
- Patients with an allergy to local anesthesia.
- Uncooperative children
- Children requiring general anesthesia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ameera Alaa ElDin, MSc Candidate in Pediatric Den contact
About this study
Official title: Comparative Evaluation of A Novel Anesthetic Device vs. Conventional Infiltration in Pain Perception Among A Group of Pediatric Patients Undergoing Extraction Of Mandibular Primary Molars: A Randomized Clinical Trial
This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique.
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.
Read more
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.
Read the detailed description
This randomized clinical trial aims to evaluate and compare the pain perception and anxiety levels associated with the use of a computer-controlled local anesthetic delivery system (SleeperOne®) versus conventional local infiltration using a standard syringe in pediatric patients undergoing extraction of mandibular primary molars.
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
- Dental Anxiety, Pain, Pain Management, Extraction, Tooth
- Being tested
- SleeperOne®, dental Hitec, France, Conventional Infiltration
- Keywords
- Pediatric dentistry, Tooth extraction, conventional infiltration, sleeperOne 5, Computer-Controlled anesthesia, Pain Perception
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleeperOne®, dental Hitec, FranceDevice
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 InfiltrationProcedure or surgery
Local anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Infiltration | Active comparator | Children will receive 3% mepivacaine with conventional syringe after 20% benzocaine Receives: Procedure: Conventional Infiltration |
| SleeperOne® Device | Experimental | Children will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine. Receives: Device: SleeperOne®, dental Hitec, France |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during injection
Pain during injection will be assessed using the Sound-Eye-Motor (SEM) pain scale, which is a validated observational scale for evaluating pain response in pediatric patients. The SEM scale consists of three components-sound, eye, and motor reaction-each scored from 1 to 4, where a lower score indicates minimal or no pain and a higher score indicates greater discomfort. The total score is interpreted to reflect the child's behavioral reaction to the injection stimulus.
Measured: immediately during local anesthetic injection
Secondary outcomes (4)
Patient anxiety
Patient anxiety will be assessed during the dental anesthesia procedure using the Modified Child Dental Anxiety Scale (MCDAS). The scale provides a subjective measure of the child's level of anxiety, scored from 8 to 40, with higher scores indicating greater anxiety.
Measured: During injection and extraction in the same clinical visit
Heart rate changes
Heart rate will be monitored using a digital pulse oximeter as an objective measure of patient anxiety. Baseline and intraoperative readings will be compared between groups.
Measured: within 15 minutes after injection
Blood pressure changes
Blood pressure will be recorded using a digital sphygmomanometer to evaluate physiological responses to local anesthesia. Baseline and intraoperative readings will be compared.
Measured: within 15 minutes after injection
Soft tissue injury
Soft tissue injury (lip or cheek biting, trauma due to numbness) will be reported by parents/patients during follow-up. Any incidence will be documented and compared between groups.
Measured: Within 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start2 Sep 2025 (estimated)
- Primary completion2 Sep 2025 (estimated)
- Study completion2 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ameera Alaa Eldin Abdalazim Khalifa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ameera Alaa Eldin Abdalazim Khalifa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156396
- Sponsor's protocol ID
- 832025
- Acronym
- SOTIMAN
- Status last verified
- Jul 2025
- First submitted
- 8 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a student-initiated academic trial, and data confidentiality will be maintained in accordance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of A Novel Anesthetic Device vs. Conventional Infiltration in Pain Perception Among A Group of Pediatric Patients Undergoing Extraction Of Mandibular Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07156396
- Acronym / sponsor ID
- SOTIMAN / 832025
- Conditions
- Dental Anxiety, Pain, Pain Management, Extraction, Tooth
- Keywords
- Pediatric dentistry, Tooth extraction, conventional infiltration, sleeperOne 5, Computer-Controlled anesthesia, Pain Perception
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ameera Alaa Eldin Abdalazim KhalifaUniversity, hospital or other
- Study start
- 2 Sep 2025 (estimated)
- Primary completion
- 2 Sep 2025 (estimated)
- Study completion
- 2 Sep 2025 (estimated)
- First posted
- 5 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique.
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.
Detailed description
This randomized clinical trial aims to evaluate and compare the pain perception and anxiety levels associated with the use of a computer-controlled local anesthetic delivery system (SleeperOne®) versus conventional local infiltration using a standard syringe in pediatric patients undergoing extraction of mandibular primary molars.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Infiltration | Active comparator | Procedure: Conventional InfiltrationChildren will receive 3% mepivacaine with conventional syringe after 20% benzocaine |
| SleeperOne® Device | Experimental | Device: SleeperOne®, dental Hitec, FranceChildren will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children Aged between 3 to 5 years.
- 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
Key exclusion criteria (3 listed)
- Patients with an allergy to local anesthesia.
- Uncooperative children
- Children requiring general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SleeperOne®, dental Hitec, FranceSleeperOne® 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. | Device | SleeperOne® Device |
| Conventional InfiltrationLocal anesthetic (3% mepivacaine) will be administered using a conventional dental syringe after the application of 20% benzocaine topical anesthetic. | Procedure or surgery | Conventional Infiltration |
Primary outcome
Pain during injection
Time frame: immediately during local anesthetic injection
Pain during injection will be assessed using the Sound-Eye-Motor (SEM) pain scale, which is a validated observational scale for evaluating pain response in pediatric patients. The SEM scale consists of three components-sound, eye, and motor reaction-each scored from 1 to 4, where a lower score indicates minimal or no pain and a higher score indicates greater discomfort. The total score is interpreted to reflect the child's behavioral reaction to the injection stimulus.
4 secondary outcomes
Patient anxiety
Time frame: During injection and extraction in the same clinical visit
Heart rate changes
Time frame: within 15 minutes after injection
Blood pressure changes
Time frame: within 15 minutes after injection
Soft tissue injury
Time frame: Within 24 hours after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- it introduces the sleeper one 5 anesthetic deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a student-initiated academic trial, and data confidentiality will be maintained in accordance with ethical standards.
Related trials for Dental Anxiety
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Evaluating Operation Calm With Children, Parents, and Clinicians
Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Recruiting
Buzzy Bee for Pain and Anxiety Control During Pediatric Dental Local Anesthesia
Anesthesia, Anxiety
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ameera Alaa ElDin, MSc Candidate in Pediatric Den contact
Questions about this trial
What is this clinical trial studying?
A study testing SleeperOne®, dental Hitec, France and Conventional Infiltration in people with Dental Anxiety and Pain, run by Ameera Alaa Eldin Abdalazim Khalifa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ameera Alaa ElDin, MSc Candidate in Pediatric Den (01156165654, ameera.khalifa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during injection (time frame: immediately during local anesthetic injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.