- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05875519
Healing Process and Blood Sugar Level Following Local Anesthetic Infiltration With and Without Vasoconstrictor
May 16, 2023 updated by: Tarek Abdelbarry, Minia University
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
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
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Minya, Egypt, 2431412
- Faculty of Dentistry, Minia University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Anaesthesia with vasocontrictor
|
Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg
|
Active Comparator: Anaesthesia without vasocontrictor
|
Mepivacaine hydrochloride 20 mg (2%) + Levonordefrin hydrochloride 0.06 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Glycemic level recorded before local anesthesia administration and 30 minutes following local anesthesia injection using glucometer
Time Frame: 30 minutes
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Healing score of the extraction socket
Time Frame: 21 days
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Actual)
May 15, 2023
Study Completion (Estimated)
May 30, 2023
Study Registration Dates
First Submitted
May 16, 2023
First Submitted That Met QC Criteria
May 16, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 16, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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