Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals
Endodontic Success of Coronally Sealed Non-obturated Canals, Regeneration-based Canals in Permanent Mature Vital Teeth
Statement of problem: Limitations and drawbacks associated with root canal obturation have the potential to impair periapical healing especially in the absence or delay of a proper coronal seal.
Aim of the study: Evaluate the endodontic treatment success in terms of resolution of signs and symptoms and periapical status using conventional periapical radiographs following two different treatment modalities, Coronally Sealed Non-obturated Canals, Regeneration-based Non-obturated Canals and comparing them to a control group of gutta percha obturated canals.
Materials and methods: Forty-eight Patients with mature, double canal, vital upper first premolars with irreversible pulpitis. In a single visit, the tooth is to be anesthetized, isolated and an access cavity is to be performed. Mechanical preparation of root canals is to be performed using the standardized technique reaching apical canal preparation to size #35 with taper of 4%. The patients will then be divided into three groups (n=16). Group One (Control group) will be conventionally obturated with gutta percha and resin sealer, and coronally sealed with glass ionomer and composite restoration. Group Two will be left unobturated and will receive a seal of MTA 2-3 mm below the CEJ then coronal restoration of glass ionomer and composite restoration. In Group Three, an induction of bleeding will be performed by apical violation and the tooth will receive a seal of MTA 2-3 mm below the CEJ then coronal seal of glass ionomer and composite restoration.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Cairo, Egypten
- Faculty of Dentistry, Ain Shams University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Males.
- Age: 18-50 years.
- Medically free.
- Vital, mature upper first premolars with irreversible pulpitis.
- Adequate coronal tooth structure.
- Compliant patients.
Exclusion Criteria:
- Generalized periodontitis.
- Females.
- Vertical root fracture.
- Immature teeth.
- Necrotic teeth.
- Systemic diseases that affect healing process.
- Non restorable teeth.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional root canal treatment
|
The canals were dried with paper points, obturated using gutta percha and resin sealer utilizing the warm vertical compaction obturation technique.
The backfilling of the canal stopped at 3mm below canal orifice.
Followed by an MTA coronal plus and glass ionomer and composite restoration.
|
|
Aktiv komparator: Regeneration group
|
The canals were be dried with paper points, and intentional over-instrumentation past the apical foramen into the periapical tissues was performed to induce bleeding inside the canal, to provide the blood clot that will act as a scaffold into which locally residing stem cells can get seeded and the cascade of healing process can initiate.
|
|
Aktiv komparator: Cleaning and Shaping only
|
The canals were dried with paper points, left unobturated and received MTA coronal plug 2-3 mm below CEJ then sealed coronally with Glass ionomer filling and composite restoration.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.
Tidsramme: 12 months
|
12 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)
Tidsramme: 12 months
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- FDASU-RECM012384
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Irreversibel Pulpitis
-
Cairo UniversityIkke rekrutterer endnuPulpitis - reversibel | Pulpitis - irreversibel
-
Mansoura UniversityAfsluttetIrreversibel Pulpitis | Reversibel PulpitisEgypten
-
Inonu UniversityRekrutteringPulpitis - reversibel | Pulpitis - irreversibelTyrkiet (Türkiye)
-
SafaAfsluttetIrreversibel Pulpitis | Reversibel Pulpitis | Sund PulpTyrkiet (Türkiye)
-
Urooj FatimaIkke rekrutterer endnuSymptomatisk irreversibel pulpitis | Irreversibel Pulpitis | Asymptomatisk irreversibel pulpitisPakistan
-
Misr International UniversityAktiv, ikke rekrutterendePulpitis | Irreversibel Pulpitis | Pulpitis - irreversibelEgypten
-
Jamia Millia IslamiaRekruttering
-
Muhammed AlagözAfsluttetIrreversibel Pulpitis | Reversibel Pulpitis | Modne tænder | Umodne tænderKalkun
-
Jordan University of Science and TechnologyAktiv, ikke rekrutterendeDyb karies | Irreversibel Pulpitis | Reversibel PulpitisJordan
-
Universidad Central de VenezuelaAfsluttetPulpitis | Rodbehandling | Pulpitis - irreversibel | PulpotomiVenezuela
Kliniske forsøg med Conventional root canal treatment
-
TC Erciyes UniversityIkke rekrutterer endnuKronisk apikal parodontitis
-
Saly NazeerAktiv, ikke rekrutterendeGenbehandling af rodkanalen | Asymptomatisk apikal parodontitisEgypten
-
bengi gülgüRekrutteringOxidativt stress | Kronisk apikal parodontitisKalkun
-
Tala Ghassan Hassan OdehTilmelding efter invitation
-
Future University in EgyptTilmelding efter invitationTilstedeværelse af ubesvarede kanaler | Morfologisk variationEgypten
-
National and Kapodistrian University of AthensAktiv, ikke rekrutterendeApikal parodontitis | RodkanalinfektionGrækenland
-
Dow University of Health SciencesAfsluttetEndodontisk sygdom | RodkanalinfektionPakistan