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

31 luglio 2026 aggiornato da: DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

120

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Bambino

Accetta volontari sani

Sì

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Pain Response During Local Anesthesia Administration Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Dental Anxiety Level Assessed by the Modified Child Dental Anxiety Scale-Faces Version (MCDASf) Lasso di tempo: 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.	Baseline (before treatment) and immediately after completion of treatment
Immediate Emotional Status Assessed by the Facial Image Scale (FIS) Lasso di tempo: 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.	Before anesthesia administration and after local anesthesia administration
Post-Treatment Pain Intensity Assessed by the Wong-Baker Faces Pain Rating Scale Lasso di tempo: 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.	Immediately after completion of treatment
Heart Rate Lasso di tempo: 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.	Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Postoperative Complications After Vital Pulp Therapy Lasso di tempo: 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.	24 hours after treatment
Blood Pressure Lasso di tempo: 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.	Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Peripheral Oxygen Saturation (SpO₂) Lasso di tempo: 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.	Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment
Body Temperature Lasso di tempo: 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.	Baseline (before local anesthesia), immediately after local anesthesia administration, during pulp exposure, and immediately after completion of treatment

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

15 novembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

28 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 luglio 2026

Primo Inserito (Effettivo)

5 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)