Clincosm LogoSign in Get a demo

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

Sponsor
Minia University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05875519
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
29
Anticipated Duration (Days)
42
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
May 1, 2023
Actual Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer [30 minutes]

Secondary Outcome Measures

  1. Healing score of the extraction socket [21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Minia University Minya Egypt 2431412

Sponsors and Collaborators

  • Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tarek Abdelbarry, Lecturer of Oral and Maxillofacial Surgery, Minia University
ClinicalTrials.gov Identifier:
NCT05875519
Other Study ID Numbers:
  • 714
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nordefrin
Mepivacaine

Study Results

No Results Posted as of May 25, 2023