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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
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISA (Intraseptal Anaesthesia) | Experimental | Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
|
| PLA (Periodontal Ligament Anaesthesia) | Experimental | Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraseptal anaesthesia (ISA) | Procedure | 0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthetic success rate | Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus. | During tooth extraction procedure (5 minutes after administration of local anaesthesia). |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time of local anesthesia | Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue. | Immediately after administration of local anesthesia (during procedure) |
| Duration of soft tissue anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Biocanin | Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad | Pančevo | Vojvodina | Serbia |
IPD will not be shared in order to protect participant privacy and ensure compliance with data protection regulations. Only summarized data will be made available in published results.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants with controlled Type 2 diabetes mellitus were randomly assigned to receive either intraseptal anaesthesia (ISA) or periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system. The study compared the two interventions in a parallel-group design during tooth extraction procedures.
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|
| Periodontal ligament anaesthesia (PLA) | Procedure | 0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars. |
|
Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva. |
| During and after procedure (measured at 5-minute intervals until sensation returns) |
| Width of anesthetic field | Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler. | 10 minutes after successful anesthesia |
| Systolic blood pressure changes | Changes in systolic blood pressure before, during, and after administration of local anesthesia. | Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection |
| Diastolic blood pressure changes | Changes in diastolic blood pressure during perioperative period of anesthesia administration. | Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection |
| Mean arterial pressure changes | Changes in mean arterial pressure during and after administration of local anesthesia. | Baseline to 30 minutes post-injection |
| Heart rate changes | Changes in heart rate during and after administration of local anesthesia using ECG monitoring. | Baseline, during injection, and 5, 10, 15, 30 minutes after administration |
| D004700 | Endocrine System Diseases |