Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

NCT07524569 | Recruiting DMC

• 1 other identifier: 2025/75
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of digital intraosseous anesthesia and manual intraligamentary anesthesia techniques on pain scores during the restorative treatment of permanent mandibular molars in pediatric patients. In addition, the techniques will be compared in terms of injection pain, anesthetic success, postoperative complications, and patient preferences. This randomized, controlled, crossover, single-blind, split-mouth study will be conducted on 78 children aged 6-12 years. Participants with bilateral permanent mandibular molars presenting enamel-dentin carious lesions will be included in the study.

Conditions

Anesthesia; Local

Keywords

intraligamentary anesthesia; paediatric dentistry; Digital Intraosseous Anesthesia

Outcome Measures

Primary Outcomes (6)

• Pain intensity using Visual Analog Scale (VAS)

  Subjective pain perception measured using a 0-10 Visual Analog Scale (0 = no pain, 10 = worst possible pain). Pain is assessed during injection and during dental treatment.

  During injection and during dental procedure

• Pain intensity using Wong-Baker FACES Pain Rating Scale

  Subjective pain perception measured using the Wong-Baker FACES Pain Rating Scale (0-10), where higher scores indicate greater pain. Pain is assessed during injection and during dental treatment.

  During injection and during dental procedure

• Heart rate changes

  Heart rate measured using a pulse oximeter (beats per minute, bpm).

  Baseline, during injection and during dental procedure

• Oxygen saturation (SpO₂) changes

  Arterial oxygen saturation measured using a pulse oximeter (%).

  Baseline, during injection and during dental procedure

• Practitioner's assessment of anesthesia success

  Clinician-reported outcomes including need for additional anesthesia, presence of discomfort during treatment, and successful completion of the procedure without pain.

  Immediately after dental treatment

• Postoperative complications

  Presence of postoperative complications related to local anesthesia.

  Day 1 after intervention

Secondary Outcomes (1)

• Correlation between pain scores measured by VAS and Wong-Baker FACES scale

  Immediately after injection

Study Arms (2)

Intraligamentary Anaesthesia

EXPERIMENTAL

Before the restorative treatment of mandibular first molar, SOPIRA® 30 gauge extra-short cartridge needle attached to the tip of the SOPIRA® Citoject (SOPIRA® Heraeus Kulzer, Hanau, Almanya) pressure injector will be inserted into the periodontal sulcus 1-2 mm until resistance. The needle will be at an angle of 30 degrees to the long axis of the tooth. As recommended by the manufacturer, a total of 0.36 ml (mesiobuccal and distobuccal) 4% articaine solution containing 1:100,000 epinephrine (Ultracaine DS forte cartridge, Sanofi-Aventis GmbH, Almanya) will be injected slowly over 42 seconds by pressing the dosing lever 3 times for each root. If the anaesthesia will be failed, we would use the 4-point IL injection by injecting the mesiolingual sulcus and distolingual sulcus with the same technique.

Procedure: Intraligamentary anaesthesia

Digital Intraosseous Anesthesia

ACTIVE COMPARATOR

For the digital intraosseous anesthesia technique, the handpiece will be stabilized by holding it as close to the needle as possible and maintaining firm support on the device holder to ensure maximum precision. To enhance the accuracy of movements, stable intraoral finger rests will be used throughout the procedure. The Effitec needle will be positioned at the papillary apex and oriented toward the area between the apices of the two adjacent teeth. To maintain correct needle positioning and prevent rotational movement, the handpiece will be held nearly parallel to the gingival tissues. Penetration will be directed toward the center of the interdental septum. When the needle enters the cancellous bone, a characteristic sensation similar to cracking an eggshell may be perceived. Before initiating the injection, the needle will be slightly withdrawn to ensure proper placement and avoid excessive penetration.

Procedure: Digital Intraosseous Anesthesia

Interventions

Intraligamentary anaesthesia PROCEDURE

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

Also known as: 2 or 4 points intraligamentary injection

Intraligamentary Anaesthesia

Digital Intraosseous Anesthesia PROCEDURE

Anesthesia for one tooth using computer-controlled single-point injection into cancellous bone

Digital Intraosseous Anesthesia

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects with American Society of Anesthesiologists score I (ASA I)
• Subjects with Frankl's behavior rate III (positive) and IV (definitely positive),
• Subjects with indication of similar restoration treatment on bilateral first -permanent mandibular molars
• Subjects whose plaque index score of 0 (no plaque) and 1
• Subjects whose gingival index score of 0

You may not qualify if:

• Allergic to the local anesthetics or sulfites
• Subjects with cholinesterase deficiency
• Subjects who use drugs that may affect the assessment of pain, such as narcotic or non-narcotic analgesic, anti-inflammatory, anxiolytic, antipsychotic and antihistamine agents
• Subjects who need to use sedatives or other medications during dental procedures

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Faculty of Dentistry

Izmir, Cigli, 35000, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Funda Çağırır Dindaroğlu, Study Director

CONTACT

+905363465653; fundacagirir@gmail.com

Buse Düzgün, Principal Investigator

CONTACT

+905073022366; busedzgn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization was performed by a computer-generated random sorting sequence
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Randomized controlled, single-blind, split-mouth clinical trial

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)