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NCT Number: NCT07748390

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

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.

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Key information

Conditions

Pediatric Anesthesia

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

  1. Pain Response During Local Anesthesia Administration

    Time frame: 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.

Secondary outcomes

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

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

    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.

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

    Time frame: Before anesthesia administration and after local anesthesia administration

    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.

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

    Time frame: Immediately after completion of treatment

    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.

  4. Heart Rate

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

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

  5. Postoperative Complications After Vital Pulp Therapy

    Time frame: 24 hours after treatment

    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.

  6. Blood Pressure

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

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

  7. Peripheral Oxygen Saturation (SpO₂)

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

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

  8. Body Temperature

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

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

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Other

Registry information

Official study title

Evaluation of the Effects of Different Local Anesthesia Techniques on Dental Anxiety and Pain During Vital Pulp Therapy

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2026
Registry last updated
Aug 5, 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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