NCT03725579

Brief Summary

The aim of this prospective randomized clinical trial was compare between 2% Mepivacaine and 4% Articaine for inferior alveolar nerve blocks in patients with symptomatic irreversible pulpitis in mandibular molars as regards to their anesthetic efficiency; during access cavity preparation and instrumentation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 23, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 23, 2018

Last Update Submit

October 31, 2018

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Anesthetic efficacyInferior alveolar nerve blocks

Outcome Measures

Primary Outcomes (1)

  • Pain intensity: Numerical rating scale (NRS)

    Pain intensity during access cavity preparation using numerical rating scale (NRS). The scale was numerical to facilitate its use by the participants. The Numerical rating scale is an 10-point scale anchored by two extremes "No pain" and "pain as bad as it could be". Pain was categorized into four categorical scores: (1) none \[score 0\], (2) mild \[score from 1-3\], (3) moderate \[score from 4-6\], (4) severe \[score from 7-10\].

    Fifteen minutes after injection of the anaesthetic solution

Secondary Outcomes (2)

  • Pain intensity: Numerical rating scale (NRS)

    Twenty-five minutes after injection of the anaesthetic solution

  • The number of patients who need suplemental anesthesia

    Fifteen minutes after injection of the anaesthetic solution

Study Arms (2)

mepivacaine hydrochloride

EXPERIMENTAL

2% Mepivacaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle

Drug: mepivicane hydrochlorideDrug: articane hydrochloride

articaine hydrochloride

ACTIVE COMPARATOR

4 % Articaine hydrochloride with 1:100,000 epinephrine anaesthetic solution. Each patient received two inferior alveolar nerve block injections of the tested anesthetic solution by using a side loading aspirating syringe and 27-gauge long needle

Drug: mepivicane hydrochlorideDrug: articane hydrochloride

Interventions

mepivicane hydrochlorideDRUG

Pain will be assessed during access cavity preparation and instrumentation

Also known as: mepivicane
articaine hydrochloridemepivacaine hydrochloride
articane hydrochlorideDRUG

Pain will be assessed during access cavity preparation and instrumentation

Also known as: articane
articaine hydrochloridemepivacaine hydrochloride

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients in good health (American Society of Anesthesiologists Class II or higher)
  • Patients having symptomatic irreversible pulpitis in one of their mandibular molars.
  • Age range is between 20 and 50 years.
  • Patients who can understand Visual Analogue Scales VAS.
  • Patients able to sign informed consent

You may not qualify if:

  • Patients allergic to articaine and/or mepivacaine and/or sulfur
  • Patients having active sites of pathosis in the area of injection.
  • Patients having active pain in more than one molar.
  • Patients who had taken analgesics in the 12 hours preceding the injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

RECRUITING

Study Officials

  • Marwa Bedier, PHD

    Cairo university, faculty of dentistry

    STUDY DIRECTOR

Central Study Contacts

Marwa M Bedier, PHD

CONTACT

0021006611104m.bedier81@gmail.com

Mohamed F Marakby, Master

CONTACT

elmarakby_200200@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Endodontics Département

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 31, 2018

Study Start

September 15, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

EG(1)