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Dental AnxietyNCT07366788

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

A study testing ARM 1 Physics forceps (40 Participant) and ARM 2 conventional forceps (40 Participant) in people with Dental Anxiety and Dental Pain, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 9 years
Conditions the study is for
Dental Anxiety, Dental Pain, Dental Extraction
What is being tested?
ARM 1 Physics forceps (40 Participant) and ARM 2 conventional forceps (40 Participant)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSyria
Study dates
21 May 2025to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Syria1 site
  • Department of Pediatric Dentistry - Prof. Shadi Azzawi.

    Damascus

Other trials in Syria

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
ARM 1 Physics forceps (40 Participant), ARM 2 conventional forceps (40 Participant)
Keywords
Dental pain, Physics forceps, Conventional forceps, Dental Anxiety, Dental Extraction
Medical subject headings
Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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

Study groups in NCT07366788
Study groupRoleWhat they receive
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.
Receives: Device: ARM 1 Physics forceps (40 Participant)
Arm 2: Conventional forceps - 40 participantsActive 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.
Receives: Device: ARM 2 conventional forceps (40 Participant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During local anesthesia administration (from needle insertion until needle withdrawal). During tooth extraction (from forceps application on tooth until tooth removal).

  2. Extraction Time

    Duration of extraction procedure measured from forceps application until complete removal of the tooth. - Unit of Measure: Seconds.

    Measured: Periprocedurally (during extraction),from the second the forceps is applied on the tooth until the second the tooth is out.

Secondary outcomes (3)
  1. Dental Anxiety - Pulse Rate

    Anxiety assessed objectively by pulse rate using pulse oximeter. Unit of Measure: Beats per minute (bpm)

    Measured: - Baseline (upon seating, before procedure). - After local anesthesia administration. - During extraction.

  2. Dental Anxiety - Facial Image Scale (FIS)

    Anxiety assessed subjectively using Facial Image Scale (score 1-5), very happy (score =1) to very unhappy (score =5).

    Measured: - Baseline (upon seating, before procedure). - After local anesthesia administration. - Immediately after extraction.

  3. Intraoperative Complications

    Presence or absence of tooth fracture and/or soft tissue tearing documented on structured data collection form.

    Measured: Immediately after extraction.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2026
  2. Study start21 May 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07366788
Sponsor's protocol ID
UDDS-Pedo-10-2025
Status last verified
Mar 2026
First submitted
9 Jan 2026
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36110718
  • 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.

    PubMed 37252611
  • 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.

    PubMed 32801526
  • 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.

    PubMed 25015020
  • 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.

    PubMed 34909472
  • Aljarrah D, Azzawi S. Effectiveness of Physics Forceps in Reducing Dental Pain, Anxiety, and Extraction Efficiency During Mandibular Primary Molar Extraction Among Children Aged 6-9 Years: A Randomized Clinical Trial. Int J Dent. 2026 Aug 5;2026:6648179. doi: 10.1155/ijod/6648179. eCollection 2026.

    PubMed 42564486

Questions about this trial

What is this clinical trial studying?

A study testing ARM 1 Physics forceps (40 Participant) and ARM 2 conventional forceps (40 Participant) in people with Dental Anxiety and Dental Pain, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07366788, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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