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

Damascus University

Status: Completed

Conditions: Dental Extraction; Dental Pain; Dental Anxiety; Primary Molar Tooth

Treatments: Device: ARM 2 conventional forceps (40 Participant); Device: ARM 1 Physics forceps (40 Participant)

Study type: Interventional

Funder types: Other

Identifiers

NCT07366788

2324

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

For both groups, the inclusion criteria were:

1. Children aged 6 - 9 years.
2. Healthy children with no history of neurological disorders or systemic diseases.
3. Mandibular primary molars indicated for extraction, with at least half of the root length remaining.
4. Cooperative behavior classified as Frankl 3 - 4.
5. Absence of acute inflammation or active periapical/periodontal infection at the time of extraction

Exclusion criteria

- 1. Children who were taking medications that may alter pain perception or bleeding tendency.

2. Teeth with insufficient root structure that made extraction technically unfeasible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Arm 1: Physics forceps - 40 participants.

Active Comparator group

Description:

\- 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.

Treatment:

Device: ARM 1 Physics forceps (40 Participant)

Arm 2: Conventional forceps - 40 participants

Active Comparator group

Description:

\- 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.

Treatment:

Device: ARM 2 conventional forceps (40 Participant)