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

NCT07366788 | Completed

• 1 other identifier: UDDS-Pedo-10-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Dental pain; Physics forceps; Conventional forceps; Dental Anxiety; Dental Extraction

Outcome Measures

Primary Outcomes (2)

• Dental pain

  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

  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 Outcomes (3)

• 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.

Study Arms (2)

Arm 1: Physics forceps - 40 participants.

ACTIVE COMPARATOR

\- 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)

Arm 2: Conventional forceps - 40 participants

ACTIVE COMPARATOR

\- 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)

Interventions

ARM 1 Physics forceps (40 Participant) DEVICE

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

Arm 1: Physics forceps - 40 participants.

ARM 2 conventional forceps (40 Participant) DEVICE

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

Arm 2: Conventional forceps - 40 participants

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 - 4.
• Absence of acute inflammation or active periapical/periodontal infection at the time of extraction

You may not qualify if:

• \- 1. Children who were taking medications that may alter pain perception or bleeding tendency.
• \. Teeth with insufficient root structure that made extraction technically unfeasible.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Pediatric Dentistry - Prof. Shadi Azzawi.

Damascus, Syria

Location

Related Publications (5)

• Laskar S, Singh M, Suman A, Sahu S, Mishra BP, Sahoo A. Efficacy of the Atraumatic Physics Forceps Over Conventional Extraction Forceps in Extraction of Tooth-Does it Offer an Alternative in All Types of Extraction or Only can be Used in Few Selected Types of Extraction: A Comparative Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S859-S862. doi: 10.4103/jpbs.jpbs_27_22. Epub 2022 Jul 13.

  PMID: 36110718 RESULT

• Mutashar HA, Abdulrazaq SS. Evaluation and Comparison of Physics Forceps and Conventional Forceps in Bilateral Dental Extraction: A Randomized, Split-Mouth, Clinical Study. Cureus. 2023 Apr 27;15(4):e38206. doi: 10.7759/cureus.38206. eCollection 2023 Apr.

  PMID: 37252611 RESULT

• Kapila S, Kaur T, Bhullar RS, Sandhu A, Dhawan A, Kaur A. Use of Physics Forceps in Atraumatic Orthodontic Extractions of Bilateral Premolars: A Randomized Control Clinical Study. J Maxillofac Oral Surg. 2020 Sep;19(3):347-354. doi: 10.1007/s12663-020-01347-6. Epub 2020 May 5.

  PMID: 32801526 RESULT

• Hariharan S, Narayanan V, Soh CL. Split-mouth comparison of physics forceps and extraction forceps in orthodontic extraction of upper premolars. Br J Oral Maxillofac Surg. 2014 Dec;52(10):e137-40. doi: 10.1016/j.bjoms.2014.06.013. Epub 2014 Jul 8.

  PMID: 25015020 RESULT

• Elicherla SR, Bandi S, Nunna M, Saikiran KV, Sahithi V, Nuvvula S. Comparative evaluation of efficacy of Physics Forceps versus conventional forceps in pediatric dental extractions: a prospective randomized study. J Dent Anesth Pain Med. 2021 Dec;21(6):547-556. doi: 10.17245/jdapm.2021.21.6.547. Epub 2021 Nov 26.

  PMID: 34909472 RESULT

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: May 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)