Effectiveness of Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Mandibular Primary Molars: Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Face Pain Rating Scale in Local Anaesthetic Administration
研究概览
简要总结
Background: Exodontia poses a psychological threat for children, increasing the need for profound local anesthesia to assure painless extraction and maintain child cooperation on the dental chair. Computer-controlled Intraligamentary anesthesia (CC-ILA) affects only the tooth to be treated with minimal pressure, eliminating the side effects of other conventional techniques.
Purpose of the study: To evaluate the effectiveness of CC-ILA injection in eliminating pain during extraction of mandibular primary molars compared to inferior alveolar nerve block (IANB) technique. The null hypothesis is there will be no difference in the pain experience with the use of CC-ILA compared to the IANB in pediatric patients.
Method: The study will be a double-blind randomized controlled clinical trial, parallel design. A total of 50 healthy children aged 5-7 years, will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. Children will be selected with scores 3 or 4 Frankl behavioral rating scale. Each child selected will have at least one mandibular primary molar that is indicated for extraction. Written informed consent will be obtained from guardian. Participants will be randomly allocated into two groups according to the technique of anesthesia that will be used. Group I (test group) will receive CC-ILA, while group II (control group) will receive IANB. Heart rate will be used as vital parameter of pain, and will be recorded at base line, during injection and during extraction procedure. Pain reaction will be assessed objectively by two investigators using Sensory, Eye, Motor (SEM) scale, while subjectively the pain will be evaluated by asking the child to express his experience using a modified face scale from the Maunuksela scale.
详细描述
AIM OF THE STUDY
Primary aim:
• To evaluate the effectiveness of computer - controlled Intraligamentary Anaesthesia in eliminating pain during extraction of primary mandibular molars compared to Inferior Alveolar Nerve Block.
Secondary aims:
- To assess and compare the pain experience during Local Anaesthesia injection of mandibular primary molars between computer - controlled Intraligamentary Anaesthesia and conventional Inferior Alveolar Nerve Block.
- To assess and compare the pain experience during extraction of mandibular primary molars when using the two different anaesthesia techniques.
- To record the occurrence of any adverse events.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The researcher (operator) who will perform all the injections and extractions as well as record heart rate measurements cannot be blinded to the type of intervention; a second impartial observer (evaluator) will record the Sensory, Eye, Motor (SEM) scale independently. The statistician will be blinded to the treatment groups. Since the participants will also be blinded, therefore, the study will be triple-blind.
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range from 5 - 7 years.
- •Children free of any systemic disease or special health care need (ASA I).
- •No previous bad dental experience.
- •Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4).
- •Patients whom their mandibular primary molars are indicated for extraction:
- •Clinical signs and sympmtoms of pulp degeneration, such as swelling or sinus tracts.
- •Radiographic evidence of periapical or interradicular radiolucency.
- •Non restorable crowns.
- •Failed pulpotomies.
- •Patients whose parents will give their consent to participate.
排除标准
- •Root resorption affecting more than one third of the root length.
- •Fractured roots due to trauma.
- •Signs of mobility.
- •Ankylosed roots.
- •Active sites of pathosis in area of injection that could affect anaesthetic assessment.
- •History of allergy to local anesthesia.
结局指标
主要结局
Face Pain Rating Scale in Local Anaesthetic Administration
时间窗: approximately minute 2 - 4
A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.
Baseline Heart Rate
时间窗: mean measurement when the child is seated on the dental chair until right before the injection at 2 minute intervals. time frame was approximately Minute 0 - 2
Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
Heart Rate Measurement in Local Anaesthetic Administration
时间窗: starting from needle puncture till full local anaesthetic solution delivery. Time frame is approximately minute 2 - 4.
Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
SEM Scale in Extraction
时间窗: approximately minute 9 - 10
Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.
Heart Rate Measurement in Extraction
时间窗: patient was allowed to rest for approximately 5 minutes after the injection then extraction was started. Time frame is approximately minute 9 -10
Heart Rate will be measured using a pulse oximeter placed on child's index finger. Readings will be recorded at 2-minute intervals and the mean heart rate measurement will be calculated.
SEM Scale in Local Anaesthetic Administration
时间窗: approximately minute 2 - 4
Sound, Eye, Motor (SEM) Scale, comprises the following parameters: (1) Sound, (2) Eye, (3) Motor. For each child, the sounds, eye symptoms and body movements will be evaluated independently by a blind impartial observer using the recorded video tapes. The slightest manifestation of the sound, eyes, or motion of the patient is graded in four levels: comfort, mild, moderate, and severe discomfort, and subsequently given grades 1, 2, 3, 4, respectively. SEM score will be calculated by summing the three grades of the parameters.
Face Pain Rating Scale in Extraction
时间窗: approximately minute 9 - 10
A modified face scale from the Maunuksela et al scale will be used to subjectively record pain during LA injection and extraction. It consists of three schematic faces with different facial expressions for happy and sad faces representing: (A) satisfaction; (B) indifference; and (C) dissatisfaction, respectively.
次要结局
- Assessment of Occurrence of Adverse Events(after 24 hours)
研究者
Rodaina Helmy
Instructor, Pediatric Dentistry and Dental Public Health Department,Faculty of Dentistry, Alexandria University
Alexandria University