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NCT04947267

To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor

Completed Phase 2 Last updated 1 July 2021
What this trial tests

Phase 2 trial testing 3% Mepivacaine Hydrochloride in LOCAL ANESTHESIA in 60 participants. Completed in 19 November 2019.

Timeline
30 May 2018
Primary endpoint
21 September 2019
19 November 2019

Quick facts

Lead sponsorAfshan Amjad Ali
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposediagnostic
Enrollment60
Start date30 May 2018
Primary completion21 September 2019
Estimated completion19 November 2019
Sites1 location across Pakistan

Drugs / interventions tested

Conditions studied

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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