Evaluation of Dental Pain, Anxiety, and Extraction Efficiency in Mandibular Primary Molar Extraction Using Physics Forceps in Children Aged 6-9 Years: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Dental pain
研究概览
简要总结
Tooth extraction is a common procedure and often associated with pain, fear, and discomfort especially in pediatric patients, which may lead to a negative attitude toward the dental. Therefore, identifying techniques that reduce pain and anxiety while improving procedural efficiency is of clinical importance.
This randomized clinical trial aimed to evaluate the efficiency of Physics forceps on dental pain, anxiety, and extraction in children aged 6-9 years undergoing primary molar extraction.
Eligible children requiring extraction of lower primary molars will be randomly assigned to one of two groups based on the type of extraction forceps used (Physics or conventional).
Dental anxiety will be assessed using both physiological measures (pulse rate) and subjective measures (Facial Image Scale).
Pain perception will be evaluated using the FLACC pain scale during local anesthesia administration and tooth extraction.
The duration of the extraction procedure will be recorded, and any intraoperative complications will be documented.
The findings of this study provide clinical evidence regarding the effectiveness of Physics forceps in reducing pain and anxiety and improving extraction efficiency among pediatric patients in a dental clinic, which leads to better clinical decision-making and enhanced pediatric patient care.
详细描述
This study investigates the use of a physics forceps compared with a conventional forceps during the extraction of mandibular primary molars in pediatric dental patients. Extraction of primary molars is a frequently performed procedure in pediatric dentistry and is often associated with dental anxiety, pain perception, and behavioral management challenges. Improving extraction techniques may positively influence the child's experience as well as the clinician's efficiency.
The study focuses on evaluating whether the use of a physics forceps can contribute to a more favorable clinical and patient-centered outcome when compared to traditional extraction instruments. The intervention does not introduce any additional or experimental dental procedures, as all tooth extractions included in the study are clinically indicated and performed as part of routine dental care.
The comparison between the two extraction approaches aims to assess their impact on child comfort, emotional response during treatment, and procedural efficiency. Particular attention is given to outcomes related to pain perception, anxiety levels, and the overall duration of the extraction procedure, as these factors play a significant role in pediatric dental management.
In addition to patient-centered outcomes, the study also considers operator-related and procedural aspects, including ease of use and the occurrence of intraoperative difficulties or complications. All clinical procedures are carried out following standard pediatric dental protocols, ensuring that patient safety and ethical principles are fully respected.
Data collected from this study are intended to provide clinically meaningful insight into whether Physics forceps offer advantages over conventional forceps in routine pediatric dental practice. The results may support evidence-based decision-making when selecting extraction instruments for children and may contribute to improving the overall quality of care during primary tooth extraction.
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
- Double (Participant, Investigator)
盲法说明
This was a double-blind study: both participants and the data analyst were unaware of the group allocations. The children were not informed about their group assignment or the specific aim of the study.
入排标准
- 年龄范围
- 6 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For both groups, the inclusion criteria were:
- •Children aged 6 - 9 years.
- •Healthy children with no history of neurological disorders or systemic diseases.
- •Mandibular primary molars indicated for extraction, with at least half of the root length remaining.
- •Cooperative behavior classified as Frankl 3 -
- •Absence of acute inflammation or active periapical/periodontal infection at the time of extraction
排除标准
- •Children who were taking medications that may alter pain perception or bleeding tendency.
- •2. Teeth with insufficient root structure that made extraction technically unfeasible.
研究组 & 干预措施
Arm 1: Physics forceps - 40 participants.
- Intervention Arm: Extraction of mandibular primary first and second molars using Physics forceps. Following topical anesthesia with 20% benzocaine gel, local anesthesia was administered using 4% articaine with 1:100,000 epinephrine. Tooth extraction was performed according to the manufacturer's instructions, without conventional rotational movements.
干预措施: ARM 1 Physics forceps (40 Participant) (Device)
Arm 2: Conventional forceps - 40 participants
- Control Arm: Extraction of mandibular primary first and second molars using conventional instruments, including periosteal elevators, straight elevators, and conventional pediatric forceps, following standard clinical practice.
干预措施: ARM 2 conventional forceps (40 Participant) (Device)
结局指标
主要结局
Dental pain
时间窗: During local anesthesia administration (from needle insertion until needle withdrawal). During tooth extraction (from forceps application on tooth until tooth removal).
Pain intensity assessed using FLACC behavioral observational scale (Face, Legs, Activity, Cry, Consolability), with a total score from 0 to 10(0 = Relaxation, 1 - 3 = Mild discomfort, 4 - 6 = Moderate discomfort, 7 - 10 = Severe discomfort
Extraction Time
时间窗: Periprocedurally (during extraction),from the second the forceps is applied on the tooth until the second the tooth is out.
Duration of extraction procedure measured from forceps application until complete removal of the tooth. - Unit of Measure: Seconds.
次要结局
- Dental Anxiety - Pulse Rate(- Baseline (upon seating, before procedure). - After local anesthesia administration. - During extraction.)
- Dental Anxiety - Facial Image Scale (FIS)(- Baseline (upon seating, before procedure). - After local anesthesia administration. - Immediately after extraction.)
- Intraoperative Complications(Immediately after extraction.)
研究者
Shadi Azzawi
Head of Pediatric Dentistry Department, Damascus University
Damascus University