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Comparison of the Efficacy of Inferior Alveolar Nerve Block and Digital Anesthesia in Pulpectomy of Mandibular Permanent Molars in Children

8. juni 2026 opdateret af: Nisanur Müdüroğlu, Inonu University

This study aims to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in achieving adequate anesthesia in pediatric patients presenting with acute dental pain and requiring emergency endodontic treatment of mandibular permanent molars. Achieving profound anesthesia in such cases can be challenging due to acute inflammation.

Participants will be randomly assigned to receive either conventional IANB or digital anesthesia. Pain perception during the procedure will be assessed using validated pain scales. In addition, physiological parameters including heart rate and blood pressure will be recorded to evaluate the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.

The findings of this study are expected to provide evidence-based guidance for selecting the most effective and comfortable anesthesia technique in pediatric dental patients.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Achieving effective local anesthesia in pediatric patients presenting with acute dental pain remains a significant clinical challenge, particularly in mandibular permanent molars requiring emergency endodontic treatment. The success of conventional inferior alveolar nerve block (IANB) may be reduced in the presence of acute inflammation, leading to inadequate pain control and increased patient anxiety.

Computer-controlled digital anesthesia systems have been introduced as an alternative technique that allows for a more controlled and consistent delivery of local anesthetic solution. This may improve both patient comfort and the success of anesthesia.

The aim of this randomized clinical study is to compare the effectiveness of inferior alveolar nerve block (IANB) and computer-controlled digital anesthesia in pediatric patients with acute dental pain requiring emergency endodontic treatment of mandibular permanent molars.

Participants will be randomly allocated into two groups: the IANB group and the digital anesthesia group. All procedures will be performed under standardized clinical conditions. Pain perception during anesthesia administration and treatment will be evaluated using validated pain assessment scales.

In addition to subjective pain evaluation, physiological parameters including heart rate and blood pressure will be recorded to assess the stress response associated with each anesthesia technique. Anesthesia success will be determined based on the absence of pain during treatment and the need for supplemental anesthesia.

The results of this study are expected to provide clinically relevant evidence regarding the most effective and comfortable anesthesia technique for pediatric patients, thereby improving treatment outcomes and patient experience.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

128

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Merve Bilmez Selen, PhD
  • Telefonnummer: 905457673098

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Children aged 6-14 years
  • Patients presenting with acute dental pain
  • Patients requiring emergency endodontic treatment in mandibular permanent molars
  • Cooperative patients who allowed clinical procedures
  • Patients whose parents/legal guardians provided informed consent

Exclusion Criteria:

  • Patients with systemic diseases affecting pain perception
  • Patients with known allergy to local anesthetic agents
  • Patients who used analgesics within 12 hours before treatment
  • Patients with non-restorable teeth
  • Patients with a history of behavioral management problems preventing treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Inferior Alveolar Nerve Block Group
Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
Procedure: Inferior Alveolar Nerve Block
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive computer-controlled intraosseous digital anesthesia using the SleeperOne computer-controlled local anesthesia delivery system and 4% articaine hydrochloride with 1:100,000 epinephrine.
Eksperimentel: Digital Anesthesia Group
Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
Procedure: Computer-Controlled Digital Anesthesia
Participants requiring emergency endodontic treatment for mandibular permanent molars will receive conventional inferior alveolar nerve block anesthesia using a conventional dental syringe and 4% articaine hydrochloride with 1:100,000 epinephrine.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anesthesia success during endodontic treatment
Tidsramme: During the procedure
Anesthetic success will be defined as completion of endodontic treatment without the need for supplemental anesthesia. Pain during treatment will be assessed using the Visual Analog Scale (VAS; 0-10) and will be considered in the evaluation of anesthetic success. Higher VAS scores indicate greater pain perception and lower anesthetic success.
During the procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart rate changes
Tidsramme: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
Heart rate will be recorded at predefined time points to evaluate physiological stress response during anesthesia administration and treatment.
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood pressure changes
Tidsramme: Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure
Blood pressure will be measured at predefined time points to assess the physiological stress response associated with the anesthesia techniques.
Before the procedure, during anesthetic administration, during pulp chamber roof removal, during extirpation, and immediately after the procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Inonu University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

20. marts 2027

Datoer for studieregistrering

Først indsendt

21. april 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

9. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2025/8393

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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