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NCT05531435
Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
NA trial testing local anaesthetic injection in Dental Pain and Sensation Disorder in 30 participants. Completed in 21 September 2022.
21 September 2022
Quick facts
| Lead sponsor | University of Pavia |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 7 September 2022 |
| Primary completion | 21 September 2022 |
| Estimated completion | 21 September 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- local anaesthetic injection — full drug profile →
Conditions studied
- Dental Pain and Sensation Disorder — all drugs for Dental Pain and Sensation Disorder →
- Dental Caries in Children — all drugs for Dental Caries in Children →
Sponsor
University of Pavia
Who can join
Adults 5 to 15, any sex, with Dental Pain and Sensation Disorder or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the present study is to assess if there are differences on perceived pain during local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric patients. Patients responding to the inclusion criteria will be asked to participate to the study. After signing the informed consent, they will undergo local anesthesia procedure on first or second primary molars for the subsequent performing of dental filling. The split-mouth design will randomly allocate first or second primary molar from one quadrant to SleeperOne procedure, while the contralateral one will be subdued to local anesthesia with traditional syringe. After the procedure, patients will be asked to assess the perceived pain with a Visual Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of "size" (related to the two instruments), bitter and vomit.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05531435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Pavia trials
Trials by the same sponsor.
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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 NCT05531435 (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 University of Pavia
- Last refreshed: 22 September 2022
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/NCT05531435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing