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

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.

Study Overview

• Status: Completed
• Conditions: LOCAL ANESTHESIA
• Intervention / Treatment: Drug: 3% Mepivacaine Hydrochloride; Drug: 2% Mepivacaine with 1:100,000 epinephrine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical status: healthy individuals with no current and past medical findings.
• Medications: no current medications.

• Both mature vital ipsilateral mandibular premolars:

  • Healthy premolar (ICDAS code 0)
  • Carious premolar (ICDAS code 4-6).

• Periapical status

  • Healthy premolar - Periapical Index. (Code 1).
  • Carious premolar - Periapical Index. (Code 1).

• Periodontal status

  • Healthy premolar - Classification of periodontal diseases and conditions (Code 0).
  • Carious premolar - Classification of periodontal diseases and conditions (Code 0).

Exclusion Criteria:

• Patients with oral and maxillofacial syndromes and anomalies.
• Pregnant and nursing mothers.
• Class V carious lesions (sensor of pulse oximeter was placed on intact buccal, lingual and cervical surfaces).
• Teeth with extracoronal restorations.
• Teeth with developmental defects and other anomalies.
• Dental trauma.
• Teeth with symptoms of irreversible pulpitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3% mepivacaine; 3% mepivacaine was administered via inferior alveolar nerve block.	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.; Other Names: 3% scandonest plain
Active Comparator: 2% mepivacaine with 1:100,000 epinephrine; 2% mepivacaine with 1:100,000 epinephrine was administered via inferior alveolar nerve block.	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.; Other Names: 2% scandonest special

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PULPAL OXYGEN SATURATION	Pulpal oxygen saturation levels were recorded for 60 min after administration of local anesthesia using Nellcor-PM10N pulse oximeter and Nellcor D-YS Multisite reusable sensor.	60 minutes

Collaborators and Investigators

• Sponsor: Afshan Amjad Ali
• Investigators: Principal Investigator: AFSHAN AMJAD ALI, MSc, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): September 21, 2019
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: pulpal oxygen saturation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Epinephrine; Mepivacaine
• Other Study ID Numbers: AAAli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No