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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-10
SponsorRecep Tayyip Erdogan University Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 3 trial groups
Group A: Conventional Inferior Alveolar Nerve Block
Group B: QuickSleeper Computer-Controlled Local Anesthesia
Group C: Controlled Local Anesthetic Delivery System Group

Trial outcomes

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.

Time frame
During local anesthesia administration

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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