- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07679152
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.
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Cairo, Egypten
- Faculty of dentistry, Ain shams university
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Resolution of signs and symptoms. (Clinical Assessment) (VAS)(Visual Analogue Scale) No pain on percussion or palpation, absence of swellings and sinus tracts.
Tidsram: 12 months
|
12 months
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Absence of periapical pathosis. (Periapical status in a conventional 2D periapical radiograph) (Periapical index PAI)
Tidsram: 12 months
|
12 months
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- FDASU-RECM012384
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .