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

NCT ID: NCT05875519

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-20

Study Completion Date

2023-11-30

Brief Summary

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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

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Conditions

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Diabetes Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Anaesthesia with vasocontrictor

Group Type EXPERIMENTAL

Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)

Intervention Type DRUG

Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg

Anaesthesia without vasocontrictor

Group Type ACTIVE_COMPARATOR

Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)

Intervention Type DRUG

Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg

Interventions

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Local anaesthesia with vasocontrictor (Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg)

Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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).
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Abdelbarry

Lecturer of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry, Minia University

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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714

Identifier Type: -

Identifier Source: org_study_id