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NCT Number: NCT07524569

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children

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.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izmir Katip Çelebi University Faculty of Dentistry

Izmir, Cigli, 35000, Turkey (Türkiye)

Location status: Recruiting

Location contact

Buse Duzgun

CONTACT

[email protected]

+905073022366

About this study

Participants who meet the eligibility criteria will be allocated into two study arms according to age, sex, dental experience, DMFT/dmft scores, ICDAS II classification, and radiographic findings. Each participant will receive two different anesthesia techniques-digital intraosseous anesthesia and manual intraligamentary anesthesia-applied to the right and left permanent first mandibular molars with a one-week washout period between visits.

The study population will be divided into two sequence groups. In Group 1 (n = 39), intraligamentary anesthesia will be administered during the first visit, followed by digital intraosseous anesthesia in the second visit. In Group 2 (n = 39), the sequence will be reversed, with digital intraosseous anesthesia administered first and intraligamentary anesthesia administered during the second visit.

Pain perception during both the injection phase and the restorative procedure will be subjectively assessed using the Visual Analog Scale (VAS) and the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate and arterial oxygen saturation, will be monitored and recorded. Anesthetic quality and success will be evaluated at the end of each visit based on the clinical outcomes of the restorative procedure.

Following each anesthesia administration, participants will be informed of potential complications, including allergic reactions, a sensation of tooth elevation, or postoperative sensitivity related to the restoration. They will be instructed to document any complications encountered. Postoperative complications will be collected by contacting participants one day after both the first and second visits. At the end of the second visit, each participant's preferred anesthesia technique will also be recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Intraligamentary anaesthesia

Procedure

Anesthesia One tooth anaesthesia by 2 or 4 points intraligamentary injection

Other names: 2 or 4 points intraligamentary injection

Digital Intraosseous Anesthesia

Procedure

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

Primary outcomes

  1. Pain intensity using Visual Analog Scale (VAS)

    Time frame: During injection and during dental procedure

    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.

  2. Pain intensity using Wong-Baker FACES Pain Rating Scale

    Time frame: During injection and during dental procedure

    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.

  3. Heart rate changes

    Time frame: Baseline, during injection and during dental procedure

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

  4. Oxygen saturation (SpO₂) changes

    Time frame: Baseline, during injection and during dental procedure

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

  5. Practitioner's assessment of anesthesia success

    Time frame: Immediately after dental treatment

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

  6. Postoperative complications

    Time frame: Day 1 after intervention

    Presence of postoperative complications related to local anesthesia.

Secondary outcomes

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

    Time frame: Immediately after injection

    Correlation between pain scores measured using the Visual Analog Scale (VAS, 0-10) and Wong-Baker FACES Pain Rating Scale (0-10) following local anesthetic injection in children aged 6-12 years. Higher scores indicate greater pain intensity.

Study contacts

Contact information is provided by the study sponsor or research team.

Buse Düzgün, Principal Investigator

CONTACT

[email protected]

+905073022366

Funda Çağırır Dindaroğlu, Study Director

CONTACT

[email protected]

+905363465653

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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