Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia

NCT07585812 | Completed

• 1 other identifier: RTEU_2019/05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized split-mouth clinical trial evaluated the efficacy of the Comfort-in needle-free injection system compared with conventional dental injection for local anesthesia during pulpotomy treatment in children. Sixty children aged 5 to 8 years who required bilateral pulpotomy of primary first molars were included. Each participant received both anesthesia techniques in separate treatment sessions with an interval of at least one week. The order of anesthesia techniques was randomized: 30 children received conventional dental injection in the first session and Comfort-in needle-free injection in the second session, while the remaining 30 children received the interventions in the reverse order. Pain perception during anesthesia administration and pulpotomy was assessed using the Face, Legs, Activity, Cry, Consolability scale and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including blood pressure, pulse, and oxygen saturation, were recorded before anesthesia, after anesthesia, and after pulpotomy. The amount of anesthetic solution used, duration of anesthetic effect, postoperative complications, and patient preference were also recorded. The study was designed to determine whether the Comfort-in needle-free injection system could provide effective local anesthesia for pediatric pulpotomy while reducing injection-related pain, physiological stress responses, anesthetic volume, duration of postoperative numbness, and postoperative complications compared with conventional dental injection.

Conditions

Dental Anxiety; Dental Pain; Pulpotomy; Local Anesthesia

Keywords

Comfort-in; Needle-free injection; Dental local anesthesia; Conventional dental injection; Injection pain

Outcome Measures

Primary Outcomes (1)

• Pain during local anesthesia administration assessed by the FLACC scale

  Pain-related behavior during local anesthesia administration was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates five behavioral categories: face, legs, activity, cry, and consolability. The total score ranges from 0 to 10, with higher scores indicating greater pain.

  Periprocedural at Visit 1 and Visit 2, during local anesthesia administration; visits were separated by at least 1 week.

Secondary Outcomes (10)

• Pain during local anesthesia and pulpotomy assessed by the Wong-Baker FACES Pain Rating Scale

  Immediately after local anesthesia administration and immediately after pulpotomy in each treatment session

• Pain during pulpotomy procedure steps assessed by the FLACC scale

  Periprocedural at Visit 1 and Visit 2, during prespecified pulpotomy procedure steps.

• Systolic blood pressure

  Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session

• Diastolic blood pressure

  Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session

• Pulse rate

  Immediately before anesthesia, immediately after anesthesia, and immediately after pulpotomy in each treatment session

Study Arms (2)

Conventional Dental Injection First, Comfort-in Needle-Free Injection Second

ACTIVE COMPARATOR

Participants in this arm received conventional dental injection in the first treatment session and Comfort-in needle-free injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions.

Device: Comfort-in Needle-Free Injection System; Procedure: Conventional Dental Injection

Comfort-in Needle-Free Injection First, Conventional Dental Injection Second

EXPERIMENTAL

Participants in this arm received Comfort-in needle-free injection in the first treatment session and conventional dental injection in the second treatment session. The two sessions were performed on contralateral primary first molars requiring pulpotomy, with a minimum interval of one week between sessions.

Device: Comfort-in Needle-Free Injection System; Procedure: Conventional Dental Injection

Interventions

Comfort-in Needle-Free Injection System DEVICE

The Comfort-in needle-free injection system was used to administer local anesthetic solution without needle penetration. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using the Comfort-in system before pulpotomy treatment of the primary first molar.

Comfort-in Needle-Free Injection First, Conventional Dental Injection Second; Conventional Dental Injection First, Comfort-in Needle-Free Injection Second

Conventional Dental Injection PROCEDURE

Conventional local anesthesia was administered using a dental injector. After drying the injection site and applying topical anesthetic spray for 60 seconds, articaine hydrochloride with epinephrine 1:100,000 was administered using a 27-gauge dental injector before pulpotomy treatment of the primary first molar.

Comfort-in Needle-Free Injection First, Conventional Dental Injection Second; Conventional Dental Injection First, Comfort-in Needle-Free Injection Second

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 5 to 8 years.
• Children requiring pulpotomy treatment of bilateral primary first molars located in either the maxilla or mandible.
• Children with no previous experience of local anesthesia or dental treatment.
• Children who showed positive or definitely positive behavior according to the Frankl Behavior Rating Scale during the initial examination.
• Children with no systemic disease.
• Children with no mental or cognitive disability.
• Children who had not used medications that could affect pain perception, including antibiotics or analgesics.
• Written informed consent obtained from the parents or legal guardians.

You may not qualify if:

• Previous dental treatment experience.
• Previous local anesthesia experience.
• Uncooperative behavior during the initial examination.
• Presence of systemic disease.
• Presence of mental or cognitive disability.
• Antibiotic use within the last month.
• Analgesic use within the last 24 hours.
• Use of any medication that could influence pain perception.
• Refusal of parental or legal guardian consent.

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Rize Province, 53000, Turkey (Türkiye)

Location

Related Publications (17)

• Yildirim S, Tokuc M, Aydin MN. The effect of pre-anesthesia with a needle-free system versus topical anesthesia on injection pain of the inferior alveolar nerve block: a randomized clinical trial. Clin Oral Investig. 2020 Dec;24(12):4355-4361. doi: 10.1007/s00784-020-03301-9. Epub 2020 May 7.

  PMID: 32382924 BACKGROUND

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• Arapostathis KN, Dabarakis NN, Coolidge T, Tsirlis A, Kotsanos N. Comparison of acceptance, preference, and efficacy between jet injection INJEX and local infiltration anesthesia in 6 to 11 year old dental patients. Anesth Prog. 2010 Spring;57(1):3-12. doi: 10.2344/0003-3006-57.1.3.

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• 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.

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• Altan H, Almas B. Clinical evaluation of different types of injection systems and comparison of pain acceptance in palatal anesthesia in pediatric patients: a randomized controlled split-mouth study. J Dent Anesth Pain Med. 2025 Jun;25(3):191-199. doi: 10.17245/jdapm.2025.25.3.191. Epub 2025 May 30.

  PMID: 40521423 BACKGROUND

• Sermet Elbay U, Elbay M, Yildirim S, Kaya E, Kaya C, Ugurluel C, BaydemIr C. Evaluation of the injection pain with the use of DentalVibe injection system during supraperiosteal anaesthesia in children: a randomised clinical trial. Int J Paediatr Dent. 2016 Sep;26(5):336-45. doi: 10.1111/ipd.12204. Epub 2015 Sep 15.

  PMID: 26369274 BACKGROUND

• Elbay M, Sermet Elbay U, Yildirim S, Ugurluel C, Kaya C, Baydemir C. Comparison of injection pain caused by the DentalVibe Injection System versus a traditional syringe for inferior alveolar nerve block anaesthesia in paediatric patients. Eur J Paediatr Dent. 2015 Jun;16(2):123-8.

  PMID: 26147818 BACKGROUND

• Makade CS, Shenoi PR, Gunwal MK. Comparison of acceptance, preference and efficacy between pressure anesthesia and classical needle infiltration anesthesia for dental restorative procedures in adult patients. J Conserv Dent. 2014 Mar;17(2):169-74. doi: 10.4103/0972-0707.128063.

  PMID: 24778516 BACKGROUND

• Ocak H, Akkoyun EF, Colpak HA, Demetoglu U, Yucesoy T, Kilic E, Alkan A. Is the jet injection effective for teeth extraction? J Stomatol Oral Maxillofac Surg. 2020 Feb;121(1):19-24. doi: 10.1016/j.jormas.2019.05.001. Epub 2019 May 8.

  PMID: 31077857 BACKGROUND

• Naik SS, Kodical SR, Joshi A, Mali S, Shah R, Shetiya N. Efficacy and Pain Perception of a Comfort-in for Palatal Anesthesia in Pediatric Dental Patients: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2026 Feb;19(2):228-233. doi: 10.5005/jp-journals-10005-3418. Epub 2026 Feb 12.

  PMID: 41799997 BACKGROUND

• Oliveira ACA, Amorim KS, Nascimento Junior EMD, Duarte ACB, Groppo FC, Takeshita WM, Souza LMA. Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial. J Appl Oral Sci. 2019 Jan 14;27:e20180195. doi: 10.1590/1678-7757-2018-0195.

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• Kanaa MD, Meechan JG, Corbett IP, Whitworth JM. Speed of injection influences efficacy of inferior alveolar nerve blocks: a double-blind randomized controlled trial in volunteers. J Endod. 2006 Oct;32(10):919-23. doi: 10.1016/j.joen.2006.04.004. Epub 2006 Jul 7.

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• Friedman MJ, Hochman MN. The AMSA injection: a new concept for local anesthesia of maxillary teeth using a computer-controlled injection system. Quintessence Int. 1998 May;29(5):297-303.

  PMID: 9693648 BACKGROUND

• Al-Melh MA, Andersson L. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 May;103(5):e16-20. doi: 10.1016/j.tripleo.2006.11.033. Epub 2007 Feb 27.

  PMID: 17331753 BACKGROUND

• Amrollahi N, Rastghalam N, Faghihian R. EFFECT OF PRE-COOLING ON PAIN ASSOCIATED WITH DENTAL INJECTIONS IN CHILDREN: A SYSTEMATIC REVIEW. J Evid Based Dent Pract. 2021 Sep;21(3):101588. doi: 10.1016/j.jebdp.2021.101588. Epub 2021 Jun 4.

  PMID: 34479670 BACKGROUND

• Bilsin E, Gungormus Z, Gungormus M. The Efficacy of External Cooling and Vibration on Decreasing the Pain of Local Anesthesia Injections During Dental Treatment in Children: A Randomized Controlled Study. J Perianesth Nurs. 2020 Feb;35(1):44-47. doi: 10.1016/j.jopan.2019.06.007. Epub 2019 Sep 26.

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• Arslan I, Aydinoglu S, Karan NB. Can lavender oil inhalation help to overcome dental anxiety and pain in children? A randomized clinical trial. Eur J Pediatr. 2020 Jun;179(6):985-992. doi: 10.1007/s00431-020-03595-7. Epub 2020 Feb 6.

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Related Links

• Instruction Manual. Comfort-in™ Needle-Free Injection System \[Internet\]. \[cited Apr 16 2026\]. Available from: http://www.comfort-in. com/file/English-French%20manual.pdf

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 Officials

• Sema Aydinoglu, DDS, PhD

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This was a randomized split-mouth clinical trial. Each participant received both anesthesia techniques in two separate treatment sessions with a minimum interval of one week. Participants were randomized to one of two intervention sequences: conventional dental injection followed by Comfort-in needle-free injection, or Comfort-in needle-free injection followed by conventional dental injection. Contralateral primary first molars requiring pulpotomy were treated in separate sessions.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 14, 2026
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)