NCT07366788

Clinical Outcomes of Mandibular Primary Molar Extraction Using Physics Forceps in Children

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Dental Anxiety
• Dental Pain
• Dental Extraction
• Primary Molar Tooth

Interventions

Type	Name	Description
DEVICE	ARM 1 Physics forceps (40 Participant)	After obtaining the child's medical history, clinical and radiographic exams assessed the restorability of lower primary molars and the need for extraction. Written informed consent was obtained from parents/guardians. Participants were randomized using a computer-generated sequence (www.randomization.com). Baseline anxiety was measured via pulse rate and the Facial Image Scale. The procedure was explained using Tell-Show-Do. Topical 20% benzocaine was applied before 4% articaine with 1:100.00 epinephrine. Pain during anesthesia was assessed with FLACC. Post-anesthesia anxiety was reassessed and anesthesia adequacy verified. Tooth extraction was performed with physics ; pain, anxiety, and procedure duration were recorded. Post-extraction, tooth fracture, gingival tearing were evaluated , and postoperative instructions were given
DEVICE	ARM 2 conventional forceps (40 Participant)	After obtaining the child's medical history, clinical and radiographic exams assessed the restorability of lower primary molars and the need for extraction. Written informed consent was obtained from parents/guardians. Participants were randomized using a computer-generated sequence (www.randomization.com). Baseline anxiety was measured via pulse rate and the Facial Image Scale. The procedure was explained using Tell-Show-Do. Topical 20% benzocaine was applied before 4% articaine with 1:100.00 epinephrine. Pain during anesthesia was assessed with FLACC. Post-anesthesia anxiety was reassessed and anesthesia adequacy verified. Tooth extraction was performed by conventional forceps; pain, anxiety, and procedure duration were recorded. Post-extraction, tooth fracture, gingival tearing were evaluated , and postoperative instructions were given

Timeline

• Start date: 2025-05-21
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2026-01-26
• Last updated: 2026-03-19

Locations

1 site across 1 country: Syria