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

Not Applicable

Completed

• Conditions: Diabetes; Anesthesia, Local
• Interventions: Drug: Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)

• Registration Number: NCT05875519
• Lead Sponsor: Minia University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-16
• Study Start: 2023-05-20
• Study First Posted: 2023-05-25
• Primary Completion: 2023-11-20
• Study Completion: 2023-11-30
• Last Update Submitted: 2024-12-28
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anaesthesia with vasocontrictor	Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)	-
Anaesthesia without vasocontrictor	Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)	-

Primary Outcome Measures

Name	Time	Method
Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer	30 minutes

Secondary Outcome Measures

Name	Time	Method
Healing score of the extraction socket	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Minia University; 🇪🇬 Minya, Egypt