Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Anesthetic success rate
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ISA (Intraseptal Anaesthesia)
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.
干预措施: Intraseptal anaesthesia (ISA) (Procedure)
PLA (Periodontal Ligament Anaesthesia)
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.
干预措施: Periodontal ligament anaesthesia (PLA) (Procedure)
结局指标
主要结局
Anesthetic success rate
时间窗: 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.
次要结局
- Onset time of local anesthesia(Immediately after administration of local anesthesia (during procedure))
- Duration of soft tissue anesthesia(During and after procedure (measured at 5-minute intervals until sensation returns))
- Width of anesthetic field(10 minutes after successful anesthesia)
- Systolic blood pressure changes(Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection)
- Diastolic blood pressure changes(Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection)
- Mean arterial pressure changes(Baseline to 30 minutes post-injection)
- Heart rate changes(Baseline, during injection, and 5, 10, 15, 30 minutes after administration)
研究者
Vladimir Biocanin
Full professor
University of Business Academy in Novi Sad, Serbia