Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor

December 28, 2024 updated by: Tarek Abdelbarry, Minia University

Evaluation of Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor for Extraction of Maxillary Teeth in Diabetic Patients Double Blind Randomized Clinical Trial

Evaluating the healing of the extraction socket and the glycemic levels before, and after injection of local anesthesia with and without vasoconstrictor in diabetic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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:

  • Inclusion criteria patients over 20 years and under 60 years of age
  • DM controlled by medication
  • Requiring a tooth extraction in the maxilla, with an indication of the intra-alveolar technique for periodontal reasons.
  • Only participants that are willing to control and record blood glucose level throughout the study period.

Exclusion Criteria:

  • Patients with any significant medical condition (besides DM)
  • Alcoholic individuals
  • Patients on drugs that affect the central nervous systems
  • Patients who reported the use of drugs that might interfere with pain sensitivity
  • Pregnant and lactating women
  • Patients with 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anaesthesia with vasocontrictor
Drug: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)
Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg
Active Comparator: Anaesthesia without vasocontrictor
Drug: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)
Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer
Time Frame: 30 minutes
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing score of the extraction socket
Time Frame: 21 days

4 = Necrotic Tissue (Eschar): black, brown, or tan tissue that adheres firmly to the wound bed 3 = Slough: yellow or white tissue that adheres to the wound bed 2 = Granulation Tissue: pink or beefy red tissue with a shiny, moist, granular appearance.

1 = Epithelial Tissue: for superficial ulcers, new pink or shiny tissue that grows in from the edges or as islands on the wound surface.

0 = Closed/Resurfaced: the wound is completely covered with epithelium.
21 days

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)

May 20, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 28, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 714

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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