PainSO5PEDNCT07124052
Comparison of Pain Perception in A Group of Pediatric Patients Undergoing Maxillary Primary Molar Extraction Using A Novel Anesthetic Device Versus Traditional Infiltration
A study testing SleeperOne 5 and (Conventional Infiltration Anesthesia) in people with Pain and Extraction, Tooth, run by Aya Hesham ElSayed Mohamed ElTanahy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Pain, Extraction, Tooth
- What is being tested?
- SleeperOne 5 and (Conventional Infiltration Anesthesia)
- 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
- 2 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2025to 18 Sep 2026
- 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 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.
Who cannot join
- Uncooperative children.
- Patients with an allergy to local anesthesia.
- Children in need of treatment under 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.
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Pain, Extraction, Tooth
- Being tested
- SleeperOne 5, (Conventional Infiltration Anesthesia)
- Keywords
- Pediatric Dentistry, Pain Perception, SleeperOne 5, Computer-Controlled Anesthesia, Conventional Infiltration
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleeperOne 5Device
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.
(Conventional Infiltration Anesthesia)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Infiltration | Experimental | Children in this group will receive local anesthesia using the SleeperOne® 5 electronic anesthesia delivery system (Dental Hi-Tec, France). The anesthetic solution used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt), administered via the device which controls flow and pressure to minimize discomfort during extraction of maxillary primary molars. Receives: Device: SleeperOne 5 |
| Conventional Infiltration Technique | Active comparator | Children in this group will receive local anesthesia using conventional infiltration via a standard dental syringe with a 30-gauge short needle. The anesthetic used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt). Buccal infiltration will be administered prior to extraction of maxillary primary molars. Receives: Procedure: (Conventional Infiltration Anesthesia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception during local anesthetic injection
Pain will be assessed during the injection phase using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated tool for pediatric pain assessment. Children will be asked to point to the face that best describes their pain level immediately after the injection is completed.
Measured: during local anesthetic injection (within 1-2 minutes)
Secondary outcomes (4)
Effectiveness: Onset and recovery time of local anesthesia
Effectiveness will be evaluated by recording the time from injection to onset of anesthesia and from completion of the procedure to recovery. Timing will be measured in minutes using a stopwatch.
Measured: During and immediately after the procedure (Reference: Saoji et al., 2019)
Duration of the procedure (injecting the anesthesia)
The total length of the procedure will be recorded from the start of the anesthetic injection to the completion of tooth extraction. Time will be measured in minutes using a stopwatch.
Measured: During the procedure (Reference: Saoji et al., 2019)
Incidence of postoperative ulcers
The presence or absence of ulcers following the procedure will be evaluated through clinical examination and parental reporting. The outcome will be recorded as a binary value (yes/no).
Measured: 24 hrs follow up
Pain experienced during extraction
Pain perception during extraction will be assessed using the Sound, Eye, Motor (SEM) behavior scale. A numerical value will be recorded based on the patient's observed response.
Measured: During tooth extraction (Reference: Dhake et al., 2022)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start18 Aug 2025 (estimated)
- Primary completion18 Aug 2025 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Hesham ElSayed Mohamed ElTanahy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Hesham ElSayed Mohamed ElTanahy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124052
- Sponsor's protocol ID
- 8820255
- Acronym
- SO5PED
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07124052
- Acronym / sponsor ID
- SO5PED / 8820255
- Conditions
- Pain, Extraction, Tooth
- Keywords
- Pediatric Dentistry, Pain Perception, SleeperOne 5, Computer-Controlled Anesthesia, Conventional Infiltration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Aya Hesham ElSayed Mohamed ElTanahyUniversity, hospital or other
- Study start
- 18 Aug 2025 (estimated)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 18 Sep 2026 (estimated)
- First posted
- 15 Aug 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 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.
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 | Experimental | Device: SleeperOne 5Children in this group will receive local anesthesia using the SleeperOne® 5 electronic anesthesia delivery system (Dental Hi-Tec, France). The anesthetic solution used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt), administered via the device which controls flow and pressure to minimize discomfort during extraction of maxillary primary molars. |
| Conventional Infiltration Technique | Active comparator | Procedure: (Conventional Infiltration Anesthesia)Children in this group will receive local anesthesia using conventional infiltration via a standard dental syringe with a 30-gauge short needle. The anesthetic used is 3% mepivacaine (Mepecaine-L®, Alexandria Co. for Pharmaceuticals and Chemical Industries, Egypt). Buccal infiltration will be administered prior to extraction of maxillary primary molars. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- Uncooperative children.
- Patients with an allergy to local anesthesia.
- Children in need of treatment under 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 5A 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. | Device | Conventional Infiltration |
| (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. | Procedure or surgery | Conventional Infiltration Technique |
Primary outcome
Pain perception during local anesthetic injection
Time frame: during local anesthetic injection (within 1-2 minutes)
Pain will be assessed during the injection phase using the Wong-Baker Faces Pain Rating Scale (WBFPRS), a validated tool for pediatric pain assessment. Children will be asked to point to the face that best describes their pain level immediately after the injection is completed.
4 secondary outcomes
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)
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 22 Aug 2025.
- it introduces the sleeper one 5 anesthetic deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing SleeperOne 5 and (Conventional Infiltration Anesthesia) in people with Pain and Extraction, Tooth, run by Aya Hesham ElSayed Mohamed ElTanahy.
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 22 Aug 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 Aya Hesham ElTanahy, MSc (201112902348, aya.eltanahy@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 perception during local anesthetic injection (time frame: during local anesthetic injection (within 1-2 minutes)). 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 22 Aug 2025.