Intraligamental Local Anesthesia Versus Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars

May 26, 2023 updated by: Tarek Abdelbarry, Minia University

Efficacy of Low Dose Intraligamental Local Anesthesia as an Alternative for Infiltration Technique for Extraction of Grade II Mobility Maxillary Molars: Double Blind Randomized Clinical Trial

The study aims to assess the use of intraligamental local anesthetic injection compared to buccal infiltration for extraction of maxillary molars suffering grade II mobility in terms of pain control and extraction duration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 2431412
        • Faculty of dentistry, Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • healthy patients (class I category according to American society of anesthesiologists )
  • Age range: 20 - 60 years of age,
  • Either genders who are seeking dental extraction of maxillary molar teeth diagnosed with grade II mobility.

Exclusion Criteria:

  • Patients with tooth that require trans osseous extraction
  • Badly broken down coronal structure of the tooth to be extracted
  • Patients with significant medical conditions
  • Alcoh intake
  • Patients on drugs that affect the central nervous systems
  • Patients who reported the use of drugs that might interfere with pain sensitivity
  • Pregnant or lactating women
  • Patients who suffer from hypersensitivity to local anesthetics or non-steroidal anti-inflammatory drugs (NSAIDs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraligamental local anesthetic injection
Procedure: Intraligamental local anesthetic injection
The intraligamental technique was administered using ligajet intraligamentary jet injector (Micro Mega Company) containing Articaine hydrochloride 4% with adrenaline 1:200000 (ArtPharma Dent, inc, Egypt)
No Intervention: Buccal infiltration local anesthetic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain using visual analogue scale
Time Frame: immediately after injection
visual analogue scale (VAS) was used in which a pain score was recorded for each patient just after local anesthetic adminstration. The VAS score ranges from 0 (no pain) to 10 (extreme unbearable pain)
immediately after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 716

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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