Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Dia… (NCT07647406) | Clinical Trial Compass
CompletedNot Applicable
Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes
Serbia120 participantsStarted 2026-01-11
Plain-language summary
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
Who can participate
Age range
35 Years – 77 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Controlled Type 2 diabetes mellitus
* Age 35-77 years
* Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
* Teeth free of acute periodontal disease
* No acute dentoalveolar abscess
* No dental treatment within last 48 hours
* No smoking
* No alcohol or drug dependence
* No contraindications to local anesthetic or vasoconstrictor
Exclusion Criteria:
* Smokers
* Patients with alcohol or drug dependence
* Contraindications to local anesthetics or vasoconstrictors
* Acute periodontal disease at the site of injection
* Acute dentoalveolar abscess
* History of tooth trauma or hypersensitivity in target teeth
* Dental treatment within the last 48 hours prior to procedure
* Non-controlled diabetes mellitus (implied, since study includes controlled DM only
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial specifically looked at intraseptal and periodontal ligament injections for tooth extraction in people with Type 2 diabetes, can you explain how these techniques differ from the standard numbing injections typically used, and whether my blood sugar control might affect how well they work?
2The trial measured 'anesthetic success rate' as its main outcome — do you know what the results showed, and does that change how you would approach numbing for my tooth extraction given that I have Type 2 diabetes?
3I know that diabetes can affect healing and nerve sensitivity — is there anything about my current diabetes management or blood sugar levels that would make one anesthetic technique safer or more effective for me than another?
4Since this study is completed, would the findings from it realistically change the way my dental or oral surgery team plans anesthesia for my extraction, or is the standard approach still considered best practice for most people with Type 2 diabetes?
5Are there any extra risks or precautions I should know about when combining a tooth extraction with either of these injection techniques, specifically because I have Type 2 diabetes and may be on medications that affect healing or bleeding?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anesthetic success rate
Timeframe: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
Trial details
NCT IDNCT07647406
SponsorUniversity of Business Academy in Novi Sad, Serbia