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Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars

10. juli 2026 opdateret af: Pooja Vilas More, Goa Dental College

Comparative Evaluation of Two Pediatric Rotary Files and Hand Files In Primary Mandibular Molars With Regard to Obturation Quality and Postoperative Pain

The goal of this clinical trial is to evaluate and compare the efficacy of Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files for biomechanical preparation during pulpectomy of primary mandibular molars in children aged 5-8 years.

The main questions it aims to answer are:

  • Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems result in better obturation quality compared with manual K-files during pulpectomy of primary mandibular molars?
  • Does the use of Kedo-Nano Plus and Kedo-S Square rotary file systems reduce postoperative pain compared with manual K-files following pulpectomy?

Researchers will compare Kedo-Nano Plus rotary files, Kedo-S Square rotary files, and manual K-files to determine their effect on obturation quality and postoperative pain.

Participants will:

  • Undergo clinical and radiographic evaluation of primary mandibular molars requiring pulpectomy.
  • Be randomly allocated to one of three instrumentation groups: Kedo-Nano Plus rotary files, Kedo-S Square rotary files, or manual K-files.
  • Receive pulpectomy treatment using the assigned instrumentation technique.
  • Undergo radiographic assessment of obturation quality following treatment.
  • Have postoperative pain assessed using the Wong-Baker Faces Pain Rating Scale at 6, 12, 24, and 48 hours after treatment.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Indien
    • Goa
      • Bambolim, Goa, Indien, 403202
        • Goa Dental College and Hospital

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:

  • Normal, healthy children between five and eight years of age
  • Frankl's behavior rating: positive or definitely positive
  • Primary mandibular molars diagnosed with irreversible pulpitis
  • Intact crown structure suitable for rubber dam placement
  • Intraoral periapical radiograph showing primary molars with at least two-thirds of each root remaining

Exclusion Criteria:

  • Children with special healthcare needs or systemic medical conditions
  • Frankl's behavior rating: negative or definitely negative
  • Primary molars with unrestorable crown structure
  • Teeth with severe mobility or pathological root resorption
  • Children or parents who refused to participate in the study

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Manual K-file group
Primary mandibular pulpectomy done by manual K- files
Procedure: Pulpectomy
Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation.
Andre navne:
  • Rodbehandling
  • Non-vital pulp therapy
Enhed: Manual K files
Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Andre navne:
  • Hand files
Eksperimentel: Kedo-S Square rotary file group
Primary mandibular pulpectomy done by Kedo-S Square rotary file
Procedure: Pulpectomy
Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation.
Andre navne:
  • Rodbehandling
  • Non-vital pulp therapy
Enhed: Kedo-S Square rotary file
Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Andre navne:
  • Kedo S square
Eksperimentel: Kedo-Nano Plus rotary file group
Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file
Procedure: Pulpectomy
Pulpectomy is performed in primary mandibular molars requiring endodontic treatment. Following administration of local anesthesia and rubber dam isolation, an access cavity is prepared and the root canals are identified. Working length is determined, followed by biomechanical preparation and irrigation of the root canals. The canals are then dried and obturated with a resorbable root canal filling material. The tooth is subsequently restored with an appropriate coronal restoration. Postoperative pain is assessed at predetermined intervals following treatment, and radiographic evaluation is performed to assess the quality of obturation.
Andre navne:
  • Rodbehandling
  • Non-vital pulp therapy
Enhed: Kedo-Nano Plus rotary file
Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Andre navne:
  • Kedo-Nano Plus

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the quality of obturation between Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files after pulpectomy in primary mandibular molars
Tidsramme: At the end of the pulpectomy procedure, immediately following obturation.
Quality of obturation will be assessed radiographically following pulpectomy in primary mandibular molars. The obturation will be categorized as optimal fill, underfill, or overfill based on the extent of obturation material in relation to the radiographic apex. The outcome measure will be used to compare the effectiveness of the instrumentation techniques in achieving adequate root canal filling.
At the end of the pulpectomy procedure, immediately following obturation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the intensity of post-operative pain following pulpectomy performed using Kedo- Nano Plus, Kedo- S Square pediatric rotary single file systems and manual K files at the interval of 6,12,24 and 48 hours postoperatively.
Tidsramme: From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.
Postoperative pain will be assessed following pulpectomy in primary mandibular molars using the Wong-Baker Faces Pain Rating Scale. Pain intensity will be recorded at 6, 12, 24, and 48 hours after completion of the procedure. The outcome measure will be used to compare the level and progression of postoperative pain among the study groups over time.
From completion of the pulpectomy procedure to 48 hours postoperatively, with assessments at 6, 12, 24, and 48 hours.

Samarbejdspartnere og efterforskere

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

Sponsor

Goa Dental College

Efterforskere

  • Studieleder: Paul Chalakkal, MDS, Goa Dental College and Hospital

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)

15. januar 2025

Primær færdiggørelse (Faktiske)

2. januar 2026

Studieafslutning (Faktiske)

3. marts 2026

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GDCH/IRB/VI-2024/RPN45-41

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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