- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Alina Malik, BDS
- Telefonnummer: +923049579435
- E-post: alinamalik32198@gmail.com
Studer Kontakt Backup
- Navn: Alina Malik, BDS
- E-post: alinamalik32198@gmail.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
|
Aktiv komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy of working length achievement in mm
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Aleena Malik, BDS, Pakistan
- Hovedetterforsker: Alina Malik, School Of Dentistry,Shaheed Zulfiqar Ali Bhutto Medical University,Islamabad
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- SOD/ERB/2025/72
Plan for individuelle deltakerdata (IPD)
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