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

NCT04947267 | Completed Phase 2 DMC

• 1 other identifier: AAAli
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

LOCAL ANESTHESIA

Keywords

pulpal oxygen saturation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

3% mepivacaine

EXPERIMENTAL

3% mepivacaine was administered via inferior alveolar nerve block.

Drug: 3% Mepivacaine Hydrochloride

2% mepivacaine with 1:100,000 epinephrine

ACTIVE COMPARATOR

2% mepivacaine with 1:100,000 epinephrine was administered via inferior alveolar nerve block.

Drug: 2% Mepivacaine with 1:100,000 epinephrine

Interventions

3% Mepivacaine Hydrochloride DRUG

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.

Also known as: 3% scandonest plain

3% mepivacaine

2% Mepivacaine with 1:100,000 epinephrine DRUG

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.

Also known as: 2% scandonest special

2% mepivacaine with 1:100,000 epinephrine

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Afshan Amjad Ali: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Interventions

Mepivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• AFSHAN AMJAD ALI, MSc

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 2 % MEPIVACAINE WITH 1:100,000 EPINEPHRINE AND 3% MEPIVACAINE BOTH WERE MASKED BY DENTAL ASSISTANT WITH PINK AND BLUE COLOR RESPECTIVELY.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: July 1, 2021
• Study Start: May 30, 2018
• Primary Completion: September 21, 2019
• Study Completion: November 19, 2019
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)