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NCT04947267
To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor
Phase 2 trial testing 3% Mepivacaine Hydrochloride in LOCAL ANESTHESIA in 60 participants. Completed in 19 November 2019.
21 September 2019
Quick facts
| Lead sponsor | Afshan Amjad Ali |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 60 |
| Start date | 30 May 2018 |
| Primary completion | 21 September 2019 |
| Estimated completion | 19 November 2019 |
| Sites | 1 location across Pakistan |
Drugs / interventions tested
- 3% Mepivacaine Hydrochloride — full drug profile →
- 2% Mepivacaine with 1:100,000 epinephrine — full drug profile →
Conditions studied
- LOCAL ANESTHESIA — all drugs for LOCAL ANESTHESIA →
Sponsor
Afshan Amjad Ali — full company profile →
Who can join
Adults 15 to 50, any sex, with LOCAL ANESTHESIA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
As vasoconstrictors adversely affect pulpal hemodynamics, this study compared the pulpal oxygen saturation levels after employing inferior alveolar nerve block with 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) and 3% mepivacaine (3% Scandonest Plain).Two groups were made with 30 patients in each group. 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special) was administered to the patients in Group A whereas 3% mepivacaine (3% Scandonest Plain) was administered to the patients in Group B. Rubber dam application, cavity preparation and composite filling was then done on the selected carious mandibular premolar. Pulpal oxygen saturation levels were recorded after administration of local anesthesia with Nellcor-550 pulse oximeter and Nellcor D-YS Multisite reusable sensor.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Related trials
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 NCT04947267 (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 Afshan Amjad Ali
- Last refreshed: 1 July 2021
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/NCT04947267.
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