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

NCT ID: NCT04947267

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2019-11-19

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

3% mepivacaine

3% mepivacaine was administered via inferior alveolar nerve block.

Group Type: EXPERIMENTAL

3% Mepivacaine Hydrochloride

Intervention Type: 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.

2% mepivacaine with 1:100,000 epinephrine

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

Group Type: ACTIVE_COMPARATOR

2% Mepivacaine with 1:100,000 epinephrine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

3% scandonest plain; 2% scandonest special

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Afshan Amjad Ali

OTHER

Sponsor Role: lead

Responsible Party

Afshan Amjad Ali

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

AFSHAN AMJAD ALI, MSc

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

Dow University of Health Sciences

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

AAAli

Identifier Type: -

Identifier Source: org_study_id