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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05875519
• Other study ID #: 714
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2023
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 30, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anesthesia, Local
• Diabetes

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Minia University	Minya

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer		30 minutes
Secondary	Healing score of the extraction socket		21 days