- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07808684
Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion
Impact of Cross-Sectional Design in Single-File Rotary System on Apical Debris Extrusion and Postoperative Pain Following Single-Visit Root Canal Treatment: An In Vitro and Randomized Clinical Study
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Root canal shaping represents a critical phase in endodontic treatment, as it facilitates effective cleaning and disinfection while preserving the original canal anatomy. The objective is to create a continuously tapered conical shape from coronal to apical regions without inducing procedural errors such as canal transportation, ledge formation, zipping, or perforation.
With advancements in nickel-titanium (NiTi) technology, modern rotary systems have been developed to enhance shaping efficiency, improve debris removal, and reduce preparation time. Recently, single-file rotary systems have gained popularity due to their simplified protocols, reduced instrument fatigue, and improved clinical efficiency.
A novel concept in instrument design involves flat-sided rotary files manufactured from proprietary heat-treated NiTi alloys, such as AF One Blue and Platinum V.EU. These instruments exhibit a modified S-shaped cross-section with an inactive tip and a distinctive flat surface. The flat-sided design reduces the metal mass of the instrument, potentially enhancing flexibility, cyclic fatigue resistance,and facilitating coronal transportation of debris during instrumentation.
In contrast, One Curve is a single-file rotary system manufactured from heat treated C-wire alloy, which offers controlled memory properties, improved flexibility, and enhanced resistance to cyclic fatigue. It operates in continuous rotation and features a variable cross-sectional design that promotes efficient cutting while maintaining effective debris removal during canal preparation.
Apical extrusion of debris is an inevitable consequence of root canal instrumentation. The extrusion of dentinal debris, microorganisms, and irrigants beyond the apical foramen may induce an inflammatory response in the periapical tissues, which is considered a major contributing factor to postoperative pain. The amount of apically extruded debris has been shown to vary according to the design and kinematics of the instrumentation system used.
Despite the continuous evolution in instrument design, there is limited evidence regarding the influence of flat-sided rotary systems compared to non-flat cross-sectional systems on apical debris extrusion and postoperative pain,particularly in curved canals. Furthermore, the potential relationship between debris extrusion and the severity of postoperative pain remains insufficiently explored.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nahla Nasr El-Din Fouad Mohamed, MSC
- Telefonnummer: +201009067349
- E-post: nannanasr248@gmail.com
Studer Kontakt Backup
- Navn: Dalia Ali Mokarab, M.D
- Telefonnummer: +201068121523
- E-post: dalia.mokarab@mu.edu.eg
Studiesteder
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Minya Governorate
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Minya, Minya Governorate, Egypt
- Rekruttering
- Endodontics, Faculty of Dentistry, Minia University
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Ta kontakt med:
- Dalia Ali Mokarab, M.D
- Telefonnummer: +201068121523
- E-post: dalia.mokarab@mu.edu.eg
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Ta kontakt med:
- Ahmed Ali Yossef, M.D
- Telefonnummer: +201007335293
- E-post: ahmed.yousef@mu.edu.eg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Teeth with mature apex
- Straight root canal or mild curvature not exceeding(5-10) Schneider.
- Has intact crown ( coronal structure)
- Presence of one orifices and one apices, patency achieved by a #10-15 K-file to the apical foramen
Exclusion Criteria:
- Previous root canal treatment.
- Internal/external resorption.
- Immature root apices.
- Caries/cracks/fractures on the root surface.
- Root canal curvature more than 10 degrees.
- Teeth in which the apical minor constriction was gauged larger than a size 20 hand file.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: one curve file
About 15 cases will be subjected to one single file to the full working length.
File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation
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to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars.
Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.
Andre navn:
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Aktiv komparator: AF Fanta flat sided file system
About 15 cases will be subjected to one single file to the full working length.File will be operated at 300 rpm/2.5 Ncm torque in continuous rotation
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to evaluate and compare the amount of apically extruded debris using the AF One single-file rotary system, featuring a flat-sided design, and the One Curve rotary system in curved mesiobuccal canals of mandibular first molars.
Additionally, this study aims to assess postoperative pain associated with both systems and to investigate the potential correlation between apical debris extrusion and postoperative pain.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment of Postoperative Pain
Tidsramme: from 0 hours to 1 week after the procedure
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Pain scores will be recorded on Visual Analog Scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain.
Recording will be done everyday for 7 days period.
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from 0 hours to 1 week after the procedure
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Maged Mohamed Negm, Professor, Endodontics Department, Faculty of Dentistry, Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Single-File Rotary System
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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