- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07612228
Effect of Manual and Mechanical Glide Path Preparation on Working Length Accuracy.
Comparison of Working Length Accuracy Following Manual and Mechanical Glide Path Preparation: An In Vitro Study.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
This study is an in vitro randomized controlled experimental investigation designed to evaluate and compare the accuracy of working length achievement following manual and mechanical glide path preparation techniques during root canal treatment.
A total of 60 extracted single-rooted permanent teeth with intact roots, mature apices, and minimal canal curvature (≤15°) will be selected according to predefined inclusion and exclusion criteria. After disinfection and sterilization, the teeth will be mounted in resin blocks to ensure stability during instrumentation. The samples will then be randomly allocated into two equal groups (n = 30 each) using a computer-generated randomization method.
Standard access cavities will be prepared for all samples. Canal patency and initial working length will be determined using an electronic apex locator and confirmed with digital periapical radiographs. Silicone stoppers will be used to standardize reference points for all measurements.
In Group 1 (manual glide path group), glide path preparation will be performed using a size #10 stainless steel K-file with a watch-winding and gentle filing motion. In Group 2 (mechanical glide path group), glide path preparation will be carried out using rotary PathFile instruments in sequence with an engine-driven handpiece, following the manufacturer's recommendations. All procedures will be performed by a single operator to eliminate operator-related variability.
After completion of glide path preparation and canal shaping, the final working length will be re-determined using the same apex locator and radiographic methods. The difference between the initial and final working lengths will be measured in millimeters for each specimen and recorded as the primary outcome variable.
Statistical analysis will be performed using SPSS software. Descriptive statistics (mean and standard deviation) will be calculated, and inferential analysis will include paired t-tests for within-group comparisons and independent t-tests for between-group comparisons, with a significance level set at p < 0.05.
The results of this study are expected to provide evidence regarding which glide path preparation technique better preserves working length accuracy, thereby assisting clinicians in selecting optimal endodontic instrumentation protocols and improving treatment outcomes.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Alina Malik, BDS
- Numero di telefono: +923049579435
- Email: alinamalik32198@gmail.com
Backup dei contatti dello studio
- Nome: Alina Malik, BDS
- Email: alinamalik32198@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
Extracted permanent single-rooted teeth. Teeth with fully formed mature apices. Teeth with intact roots and no structural defects. Root canals with curvature less than 15 degrees. Teeth with patent canals allowing negotiation with a size #10 K-file.
Exclusion Criteria:
Teeth with caries, fractures, cracks, or root defects. Teeth with previous endodontic treatment. Teeth showing root resorption or calcified canals. Teeth with unusual root canal anatomy or multiple canals. Teeth with severe canal curvature greater than 15 degrees. Teeth with immature apices or open apices.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Manual Glide Path Preparation
Teeth in this arm will undergo glide path preparation using manual stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth glide path up to the predetermined working length.
|
Glide path is created using stainless steel K-files (size #10) with a watch-winding motion and gentle vertical filing to establish a smooth path from the canal orifice to the apex.
|
|
Comparatore attivo: Mechanical Glide Path Preparation
Teeth in this arm will undergo glide path preparation using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following the manufacturer's instructions to establish the glide path up to the predetermined working length.
|
Glide path is created using rotary PathFile instruments (#13 and #16) with an engine-driven handpiece, following manufacturer instructions to establish a smooth path from the canal orifice to the apex.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Accuracy of working length achievement in mm
Lasso di tempo: Six months
|
The primary outcome of this study will be the accuracy of working length achievement after glide path preparation using manual and mechanical techniques.
It will be assessed by measuring the difference between the initial working length (recorded before instrumentation) and the final working length (recorded after glide path preparation and canal shaping) in millimeters.
Working length measurements will be obtained using an apex locator and confirmed with digital periapical radiographs.
A smaller difference between the initial and final working lengths will indicate better maintenance and achievement of the accurate working length.
|
Six months
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Aleena Malik, BDS, Pakistan
- Investigatore principale: Alina Malik, School Of Dentistry,Shaheed Zulfiqar Ali Bhutto Medical University,Islamabad
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SOD/ERB/2025/72
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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