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Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars

10 settembre 2026 aggiornato da: Ayça Hande Sari, Afyonkarahisar Health Sciences University

Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study

The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.

The main questions it aims to answer are:

Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?

Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.

Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:

Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.

Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.

Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Turchia (Türkiye)
    • Afyonkarahisar
      • Afyonkarahisar, Afyonkarahisar, Turchia (Türkiye), 03030
        • Reclutamento
        • Afyonkarahisar Health Sciences University, Faculty of Dentistry
        • Contatto:

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

Descrizione

Inclusion Criteria:

  • Children aged 6-9 years.
  • Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
  • Systemically healthy children classified as ASA physical status I or II.
  • No known coagulation disorders.
  • No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
  • Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
  • Written informed consent obtained from a parent or legal guardian for participation in the study.
  • No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.

Exclusion Criteria:

  • Children with systemic health conditions classified as ASA physical status III or higher.
  • Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
  • Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
  • Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
  • Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
  • History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
  • Inability to comply with the study protocol or attend the scheduled study visits.

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

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: IANB Followed by Intraosseous Anesthesia
Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session. At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar. The time required to achieve pulp hemostasis will be recorded during both treatment sessions.
Procedura: Inferior Alveolar Nerve Block Anesthesia
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte). After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Procedura: Computer-Controlled Intraosseous Anesthesia
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
Sperimentale: Intraosseous Anesthesia Followed by IANB
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded.
Procedura: Inferior Alveolar Nerve Block Anesthesia
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte). After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Procedura: Computer-Controlled Intraosseous Anesthesia
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar. After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol. Pulp hemostasis time will be recorded following removal of the coronal pulp tissue

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pulp Hemostasis Time
Lasso di tempo: During pulpotomy, up to 5 minutes after coronal pulp removal
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session. Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
During pulpotomy, up to 5 minutes after coronal pulp removal

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Peripheral Oxygen Saturation (SpO₂)
Lasso di tempo: Immediately before local anesthesia administration
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
Immediately before local anesthesia administration
Pain Intensity
Lasso di tempo: Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale. Participants will select the face that best represents their perceived pain. The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity. Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
Heart Rate
Lasso di tempo: Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit

Collaboratori e investigatori

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

Sponsor

Afyonkarahisar Health Sciences University

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 (Effettivo)

15 aprile 2026

Completamento primario (Stimato)

1 febbraio 2027

Completamento dello studio (Stimato)

26 febbraio 2027

Date di iscrizione allo studio

Primo inviato

3 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 settembre 2026

Primo Inserito (Effettivo)

9 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 26.GENEL.013

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be made publicly available due to participant confidentiality and privacy considerations.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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