NCT04947267

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

To Compare the Pulpal Oxygen Saturation Level After Administering Mepivacaine With and Without Vasoconstrictor: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Afshan Amjad Ali · Academic / Other
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

BACKGROUND ' Local anesthesia is the foremost requirement of an efficient operative dental procedure to be executed in a pain free and calm environment. Local anesthesia is available in two forms: with vasoconstrictor and without vasoconstrictor. As vasoconstrictors adversely affect pulpal hemodynamics, this study aims to compare 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). NULL HYPOTHESIS There is no difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine. ALTERNATE HYPOTHESIS There is a difference between the pulpal oxygen saturation levels after administering 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine. METHOD 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 the Nellcor- PM 10N pulse oximeter and Nellcor D-YS Multisite reusable sensor. STATISTICAL ANALYSIS The statistical package for social sciences version 21.0 is used for statistical analysis. Mean and standard deviation of the pulpal oxygen saturation levels for filled and unfilled teeth under the effect of 2% mepivacaine with 1:100,000 epinephrine and 3% mepivacaine were recorded. Mixed Way ANOVA will be applied to discern if there is any difference in the pulpal oxygen saturation levels within and between the two groups. Post Hoc Tuckey was applied to identify whether the paired difference is present within groups or between the two groups.

Conditions

• LOCAL ANESTHESIA

Interventions

Type	Name	Description
DRUG	3% Mepivacaine Hydrochloride	1.8 ml of 3% mepivacaine (3% Scandonest, Septodont) was administered to Group B patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.
DRUG	2% Mepivacaine with 1:100,000 epinephrine	1.8 ml of 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special, Septodont) was administered to Group A patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.

Timeline

• Start date: 2018-05-30
• Primary completion: 2019-09-21
• Completion: 2019-11-19
• First posted: 2021-07-01
• Last updated: 2021-07-01

Locations

1 site across 1 country: Pakistan