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

March 17, 2026 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Syria
      • Damascus, Syria
        • Department of Pediatric Dentistry - Prof. Shadi Azzawi.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Active Comparator: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental pain
Time Frame: 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
During local anesthesia administration (from needle insertion until needle withdrawal). During tooth extraction (from forceps application on tooth until tooth removal).
Extraction Time
Time Frame: 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.
Periprocedurally (during extraction),from the second the forceps is applied on the tooth until the second the tooth is out.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Anxiety - Pulse Rate
Time Frame: - Baseline (upon seating, before procedure). - After local anesthesia administration. - During extraction.
Anxiety assessed objectively by pulse rate using pulse oximeter. Unit of Measure: Beats per minute (bpm)
- Baseline (upon seating, before procedure). - After local anesthesia administration. - During extraction.
Dental Anxiety - Facial Image Scale (FIS)
Time Frame: - Baseline (upon seating, before procedure). - After local anesthesia administration. - Immediately after extraction.
Anxiety assessed subjectively using Facial Image Scale (score 1-5), very happy (score =1) to very unhappy (score =5).
- Baseline (upon seating, before procedure). - After local anesthesia administration. - Immediately after extraction.
Intraoperative Complications
Time Frame: Immediately after extraction.
Presence or absence of tooth fracture and/or soft tissue tearing documented on structured data collection form.
Immediately after extraction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UDDS-Pedo-10-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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