Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children

NCT07748390 | Not Yet Recruiting

• 1 other identifier: 2026/319
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.

Conditions

Pediatric; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain Response During Local Anesthesia Administration

  Pain response during local anesthesia administration will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The FLACC scale evaluates behavioral pain responses in children based on five domains: facial expression, leg movement, activity, crying, and consolability. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

  During local anesthesia administration

Secondary Outcomes (8)

• Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf)

  Baseline (before treatment) and immediately after completion of treatment

• Immediate Emotional Status Assessed by the Facial Image Scale (FIS)

  Before anesthesia administration and after local anesthesia administration

• Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale

  Immediately after completion of treatment

• Heart Rate

  Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment

• Postoperative Complications After Vital Pulp Therapy

  24 hours after treatment

Study Arms (3)

Conventional Inferior Alveolar Nerve Block

Participants in this cohort receive conventional inferior alveolar nerve block anesthesia as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the anesthesia procedure is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.

QuickSleeper Computer-Controlled Local Anesthesia

Participants in this cohort receive computer-controlled local anesthetic delivery using the QuickSleeper system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The anesthesia technique is selected by the treating clinician according to standard clinical practice. No additional intervention or modification of the routine treatment protocol is performed for study purposes. Pain, dental anxiety, physiological parameters, and postoperative outcomes are evaluated and recorded.

Controlled Local Anesthetic Delivery System Group

Participants in this cohort receive computer-controlled local anesthetic delivery using the SOAN system as part of routine clinical care before vital pulp therapy of permanent mandibular first molars. The SOAN system allows controlled administration of local anesthetic solution with regulated flow and pressure during the injection procedure. The anesthesia technique is selected by the treating clinician according to standard clinical practice and clinical requirements. No additional intervention, modification of the routine treatment protocol, or procedure solely for research purposes is performed. Dental anxiety, pain responses, physiological parameters, and postoperative outcomes are evaluated and recorded during and after the routine dental treatment process.

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of children aged 8-10 years who require vital pulp therapy of permanent mandibular first molars and attend the Department of Pediatric Dentistry at Recep Tayyip Erdoğan University Faculty of Dentistry. Eligible participants will be systemically healthy children with appropriate cognitive and communication abilities and acceptable cooperation levels according to the Frankl Behavior Rating Scale (scores 3 or 4). Participants will be evaluated according to the routine clinical care provided, and the effects of different local anesthesia techniques on dental anxiety, pain response, physiological parameters, and postoperative outcomes will be assessed.

You may qualify if:

• Children aged 8-10 years.
• Children and parents/legal guardians who agree to participate in the study and provide informed consent.
• Patients requiring vital pulp therapy of a permanent mandibular first molar.
• Patients classified as Frankl Behavior Rating Scale score 3 or 4. Systemically healthy children (ASA I).
• Children with adequate cognitive and communication abilities to understand the study procedures and pain/anxiety assessment scales.
• Permanent mandibular first molars without clinical or radiographic signs of abscess, fistula, or periapical pathology.

You may not qualify if:

• Children with systemic diseases or medical conditions affecting dental treatment.
• Children classified as Frankl Behavior Rating Scale score 1 or 2.
• Patients with known allergy or hypersensitivity to local anesthetic agents (e.g., lidocaine, articaine).
• Teeth with acute dental infection signs, including abscess, cellulitis, or extensive infection.
• Teeth showing clinical or radiographic evidence of periapical pathology.
• Children unable to understand or complete pain and anxiety assessment scales due to cognitive, visual, hearing, or communication limitations.
• Patients who do not comply with the study procedures or withdraw consent.

Sponsors & Collaborators

• Recep Tayyip Erdogan University Training and Research Hospital: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 5, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 5, 2026

Record last verified: 2026-07