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Completed

NCT Number: NCT05875519

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

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

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Key information

Conditions

Diabetes Anesthesia, Local Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Minia University

Minya, 2431412, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Drug

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

Primary outcomes

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

    Time frame: 30 minutes

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 25, 2023
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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