Diabetes Mellitus Type 2
Conditions
Keywords
intraseptal anaesthesia (ISA), periodontal ligament anaesthesia (PLA), type 2 diabetes mellitus, articaine with epinephrine, local anaesthesia, CCLADS
Brief 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
Detailed description
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.
Interventions
PROCEDUREIntraseptal anaesthesia (ISA)
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.
PROCEDUREPeriodontal ligament anaesthesia (PLA)
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.
Sponsors
University of Business Academy in Novi Sad, Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 77 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anesthetic success rate | During tooth extraction procedure (5 minutes after administration of local anaesthesia). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset time of local anesthesia | Immediately after administration of local anesthesia (during procedure) | Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue. |
| Duration of soft tissue anesthesia | During and after procedure (measured at 5-minute intervals until sensation returns) | Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva. |
| Width of anesthetic field | 10 minutes after successful anesthesia | Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler. |
| Systolic blood pressure changes | Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection | Changes in systolic blood pressure before, during, and after administration of local anesthesia. |
| Diastolic blood pressure changes | Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection | Changes in diastolic blood pressure during perioperative period of anesthesia administration. |
| Mean arterial pressure changes | Baseline to 30 minutes post-injection | Changes in mean arterial pressure during and after administration of local anesthesia. |
| Heart rate changes | Baseline, during injection, and 5, 10, 15, 30 minutes after administration | Changes in heart rate during and after administration of local anesthesia using ECG monitoring. |
Countries
Serbia
Contacts
PRINCIPAL_INVESTIGATORVladimir Biocanin
Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
Outcome results
None listed