Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children

NCT07548892 | Not Yet Recruiting DMC

• 1 other identifier: OMÜKAEK 2025/462
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn whether a needle-free injection system can make tooth extraction less stressful for children than a conventional dental syringe. The study will include healthy children 6 to 12 years old who need a primary tooth extraction with buccal and lingual local anesthesia. The main questions are whether the needle-free method can lower anxiety, lower pain, and reduce changes in vital signs compared with the conventional syringe. Researchers will randomly assign participants to 1 of 2 groups. One group will receive local anesthesia with a needle-free jet injection system. The other group will receive local anesthesia with a conventional syringe and a 27-gauge dental needle. In both groups, a topical lidocaine spray will be used before the injection, and the same anesthetic solution will be given. All tooth extractions will be performed by the same clinician using standard clinical procedures. Participants' anxiety, pain, and vital signs will be checked before the procedure, after anesthesia, and after tooth extraction. Anxiety will be measured with the Face Image Scale (FIS). Pain will be measured with the Face, Legs, Activity, Cry, Consolability (FLACC) scale and the Wong-Baker Faces Pain Rating Scale (WBS). Vital signs will include systolic and diastolic blood pressure, heart rate, and oxygen saturation. No blood, saliva, or tissue samples will be collected, and no audio or video recording will be made.

Conditions

Dental Anxiety; Anesthesia, Dental; Tooth Extraction; Procedural Pain

Keywords

Needle-Free Injection; Conventional Syringe; Tooth Extraction; Pediatric Dentistry; Local Anesthesia; Dental Anxiety; Pain Perception; Vital Signs

Outcome Measures

Primary Outcomes (3)

• Anxiety level measured by Face Image Scale

  Anxiety will be assessed using the Face Image Scale (FIS), a 5-face visual anxiety scale with scores ranging from 1 to 5. Higher scores indicate greater anxiety (worse outcome).

  Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.

• Pain level measured by Wong-Baker Faces Pain Rating Scale (WBS)

  Self-reported pain will be assessed using the Wong-Baker Faces Pain Rating Scale, a 6-face scale with scores ranging from 0 to 10. Higher scores indicate greater pain (worse outcome).

  Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.

• Pain level measured by Face, Legs, Activity, Cry, Consolability (FLACC) scale

  Observed pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, with total scores ranging from 0 to 10. Higher scores indicate greater pain or distress (worse outcome).

  Immediately after completion of local anesthesia administration and immediately after tooth extraction during the same visit.

Secondary Outcomes (4)

• Diastolic blood pressure

  Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.

• Systolic blood pressure

  Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.

• Heart rate

  Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.

• Oxygen saturation

  Baseline (immediately before local anesthesia administration), immediately after completion of local anesthesia administration, and immediately after tooth extraction during the same visit.

Study Arms (2)

Needle-Free Jet Injection

EXPERIMENTAL

articipants will receive local anesthesia with a needle-free jet injection system for tooth extraction.

Device: Needle-Free Jet Injection System

Conventional Syringe

ACTIVE COMPARATOR

Participants will receive local anesthesia with a conventional syringe and a 27-gauge dental needle for tooth extraction.

Procedure: Conventional Syringe Injection

Interventions

Needle-Free Jet Injection System DEVICE

Local anesthesia will be administered to the mandibular buccal and lingual regions using a needle-free jet injection system. Topical lidocaine spray will be applied before injection, and 4% articaine with 1:100,000 epinephrine will be used.

Needle-Free Jet Injection

Conventional Syringe Injection PROCEDURE

Local anesthesia will be administered to the mandibular buccal and lingual regions using a conventional syringe with a 27-gauge dental needle. Topical lidocaine spray will be applied before injection, and 4% articaine with 1:100,000 epinephrine will be used.

Conventional Syringe

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Being between 6-12 years of age
• Having a primary tooth to be extracted with buccal and lingual anesthesia
• Being in category 2, 3, or 4 according to the Frankl Behavior Scale
• Being systemically healthy
• No known history of allergy to local anesthetics
• No antibiotic use in the last month and no analgesic use in the last 12 hours
• Not having acute dental pain
• Having sufficient cognitive ability to understand the anxiety assessment scales
• Voluntary participation with written parental consent

You may not qualify if:

• Being under 6 years of age or over 12 years of age
• Displaying category 1 behavior according to the Frankl scale
• Presence of severe acute dental infection or a condition requiring emergency intervention
• Presence of a requirement for surgical extraction in the tooth indicated for extraction
• Incomplete root development of the underlying permanent tooth
• History of systemic disease (for example heart disease, uncontrolled asthma, epilepsy, diabetes)
• Inability to use pain/anxiety scales due to neurological or developmental disorder
• History of allergic reaction to local anesthetics or other drugs used
• Presence of hypersensitivity to odors or inhalation intolerance
• Refusal of participation by the child or parent

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Related Publications (6)

• Gosnell ES, Thikkurissy S. (2019). Assessment and management of pain in the pediatric patient. In: Pediatric Dentistry. 6th ed. Edited by Nowak AJ, Marby TR, Wells MH, Christensen JR, Townsend JA. Philadelphia: Saunders Publishers. pp. 97-115.e1.

  BACKGROUND

• St George G, Morgan A, Meechan J, Moles DR, Needleman I, Ng YL, Petrie A. Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev. 2018 Jul 10;7(7):CD006487. doi: 10.1002/14651858.CD006487.pub2.

  PMID: 29990391 BACKGROUND

• Shankar P, Chellathurai BNK, Kumar SA, Mahendra J, Mugri MH, Sayed M, Almagbol M, Al Wadei MHD, Vijayalakshmi R, Ambalavanan N, Raj AT, Patil S. A Comparison in Patient Comfort Using Conventional Syringe and Needleless Jet Anesthesia Technique in Periodontal Surgery-A Split-Mouth Randomized Clinical Trial. Medicina (Kaunas). 2022 Feb 12;58(2):278. doi: 10.3390/medicina58020278.

  PMID: 35208601 BACKGROUND

• McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.

  PMID: 30109720 BACKGROUND

• Kaya E, Yildirim S. Effect of a needle-free system versus traditional anesthesia on pain perception during palatal injections in children. Int J Paediatr Dent. 2023 Mar;33(2):132-140. doi: 10.1111/ipd.13028. Epub 2022 Oct 17.

  PMID: 36151976 BACKGROUND

• Altan H, Belevcikli M, Cosgun A, Demir O. Comparative evaluation of pain perception with a new needle-free system and dental needle method in children: a randomized clinical trial. BMC Anesthesiol. 2021 Dec 1;21(1):301. doi: 10.1186/s12871-021-01524-1.

  PMID: 34852779 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Semih Ercan Akgün, DDS, PhD

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Semih Ercan Akgün, DDS, PhD

CONTACT

+905543130919; semihercanakgun@gmail.com

Zeynep Bafra, DDS

CONTACT

+905547142371

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Participants will be randomly assigned to 1 of 2 parallel groups. One group will receive local anesthesia with a needle-free jet injection system, and the other group will receive local anesthesia with a conventional syringe. Each child will be included for only 1 tooth extraction.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 23, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share