Last reviewed · How we verify
NCT07156396: SOTIMAN
SleeperOne vs. Conventional Infiltration: Pain Perception in Mandibular Primary Molar Extraction
NA trial testing SleeperOne®, dental Hitec, France in Dental Anxiety in 28 participants. Not yet recruiting.
2 September 2025
Quick facts
| Lead sponsor | Ameera Alaa Eldin Abdalazim Khalifa |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 28 |
| Start date | 2 September 2025 |
| Primary completion | 2 September 2025 |
| Estimated completion | 2 September 2025 |
Drugs / interventions tested
- SleeperOne®, dental Hitec, France
- Conventional Infiltration
Conditions studied
- Dental Anxiety — all drugs for Dental Anxiety →
- Pain — all drugs for Pain →
- Pain Management — all drugs for Pain Management →
- Extraction, Tooth — all drugs for Extraction, Tooth →
Sponsor
Ameera Alaa Eldin Abdalazim Khalifa
Who can join
Adults 3 to 5, any sex, with Dental Anxiety or Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07156396
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07156396 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ameera Alaa Eldin Abdalazim Khalifa
- Last refreshed: 5 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07156396.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing