Comparative Evaluation of Pediatric Rotary Files and Hand Files in Primary Molars
10 luglio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
60
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.
Luoghi di studio
-
-
Goa
-
Bambolim, Goa, India, 403202
- Goa Dental College and Hospital
-
-
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
No
Descrizione
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
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: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Manual K-file group
Primary mandibular pulpectomy done by manual K- files
|
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.
Altri nomi:
Manual K files were used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Altri nomi:
|
|
Sperimentale: Kedo-S Square rotary file group
Primary mandibular pulpectomy done by Kedo-S Square rotary file
|
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.
Altri nomi:
Kedo S Square pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Altri nomi:
|
|
Sperimentale: Kedo-Nano Plus rotary file group
Primary mandibular pulpectomy done by Kedo-Nano Plus rotary file
|
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.
Altri nomi:
Kedo Nano Plus pediatric rotary file system was used for biomechanical preparation/root canal instrumentation of primary teeth as per the study protocol.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Paul Chalakkal, MDS, Goa Dental College and 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 (Effettivo)
15 gennaio 2025
Completamento primario (Effettivo)
2 gennaio 2026
Completamento dello studio (Effettivo)
3 marzo 2026
Date di iscrizione allo studio
Primo inviato
25 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
10 luglio 2026
Primo Inserito (Effettivo)
14 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
14 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GDCH/IRB/VI-2024/RPN45-41
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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-
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