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

N/ANot Yet RecruitingNCT07748390

Recep Tayyip Erdogan University Training and Research Hospital120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Pediatric Anesthesia

Eligibility

Sex: ALLMin age: 8 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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.

Time frame: During local anesthesia administration

Secondary Outcomes

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

Dental anxiety levels will be evaluated using the Modified Child Dental Anxiety Scale-Faces version (MCDASf). The scale includes eight dental situations rated on a five-point Likert scale ranging from 1 (relaxed/not anxious) to 5 (very anxious). Total scores range from 8 to 40, with higher scores indicating higher levels of dental anxiety.

Time frame: Baseline (before treatment) and immediately after completion of treatment

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

The Facial Image Scale (FIS) will be used to evaluate children's immediate emotional status and dental anxiety. The scale consists of five facial expressions ranging from very happy to very unhappy. Higher scores indicate increased anxiety levels.

Time frame: Before anesthesia administration and after local anesthesia administration

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

Pain intensity after completion of vital pulp therapy will be assessed using the Wong-Baker Faces Pain Rating Scale. The scale ranges from 0 (no pain) to 10 (worst possible pain), with higher scores indicating greater pain intensity.

Time frame: Immediately after completion of treatment

Heart Rate

Heart rate (beats per minute) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.

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

Postoperative Complications After Vital Pulp Therapy

Postoperative complications following vital pulp therapy will be assessed by contacting parents 24 hours after treatment. The presence or absence of postoperative symptoms will be recorded.

Time frame: 24 hours after treatment

Blood Pressure

Systolic and diastolic blood pressure (mmHg) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.

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

Peripheral Oxygen Saturation (SpO₂)

Peripheral oxygen saturation (%) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.

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

Body Temperature

Body temperature (°C) measured before local anesthesia, immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment.

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