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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 oppdatert av: 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.

Studieoversikt

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

128

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

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

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Inferior Alveolar Nerve Block Group
Participants receiving conventional inferior alveolar nerve block anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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.
Eksperimentell: Digital Anesthesia Group
Participants receiving computer-controlled digital anesthesia for mandibular permanent molars requiring emergency endodontic treatment.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

20. mars 2027

Datoer for studieregistrering

Først innsendt

21. april 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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