Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy

NCT07714915 | Not Yet Recruiting

• 1 other identifier: 2026/268
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care. Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements. The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.

Conditions

Dental Anxiety; Pain; Pulpal Diseases

Outcome Measures

Primary Outcomes (2)

• Dental Anxiety

  Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Higher scores indicate higher levels of dental anxiety.

  Baseline and immediately after treatment

• Behavioral Pain During Local Anesthesia

  Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration. Scores range from 0 to 10, with higher scores indicating greater pain.

  Immediately after local anesthetic injection

Secondary Outcomes (6)

• Self-reported Pain

  Immediately after local anesthetic injection

• Facial Image Scale (FIS) Score

  Baseline and immediately after treatment.

• Heart Rate

  Baseline and during local anesthetic administration

• Blood Pressure

  Baseline, during local anesthetic administration, and immediately after treatment

• Peripheral Oxygen Saturation (SpO₂)

  Baseline, during local anesthetic administration, and immediately after treatment

Study Arms (2)

Conventional Inferior Alveolar Nerve Block

ACTIVE COMPARATOR

Procedure: Conventional Inferior Alveolar Nerve Block; Drug: Articaine hydrochloride with epinephrine 1:100,000; Device: Standard Dental Aspirating Syringe

Computer-Controlled Local Anesthesia

ACTIVE COMPARATOR

Procedure: Computer-Controlled Local Anesthesia; Drug: Articaine hydrochloride with epinephrine 1:100,000; Device: Computer-Controlled Local Anesthetic Delivery System

Interventions

Articaine hydrochloride with epinephrine 1:100,000 DRUG

A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.

Computer-Controlled Local Anesthesia; Conventional Inferior Alveolar Nerve Block

Standard Dental Aspirating Syringe DEVICE

A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.

Conventional Inferior Alveolar Nerve Block

Conventional Inferior Alveolar Nerve Block PROCEDURE

Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.

Conventional Inferior Alveolar Nerve Block

Computer-Controlled Local Anesthetic Delivery System DEVICE

A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.

Computer-Controlled Local Anesthesia

Computer-Controlled Local Anesthesia PROCEDURE

Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.

Computer-Controlled Local Anesthesia

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 8 years.
• Requiring bilateral pulpectomy treatment of mandibular primary molars.
• Frankl Behavior Rating Scale score of 3 or 4.
• American Society of Anesthesiologists (ASA) Physical Status I.
• No known allergy to local anesthetic agents.
• No previous experience with dental local anesthesia.
• No signs of acute abscess or swelling in the treatment area.
• Parent or legal guardian able to provide written informed consent and child willing to participate.

You may not qualify if:

• ASA Physical Status II or higher.
• Known allergy or contraindication to local anesthetic agents.
• Frankl Behavior Rating Scale score of 1 or 2.
• Children receiving psychological or psychiatric treatment.
• Physical or intellectual disabilities that could interfere with study procedures.
• Previous experience with dental local anesthesia.
• Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Sites (1)

Recep Tayyip Erdoğan University

Merkez, Rize Province, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Carticaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

dilara nil günaçar

CONTACT

+905412940104; dilaranil.tomrukcu@erdogan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The behavioral pain assessment (FLACC score) will be performed by an independent outcome assessor who is blinded to the local anesthesia technique used. Due to the nature of the interventions, participants and treating clinicians cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)