- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07609732
Outcomes of Conventional Root Canal Treatment to Regenerative Endodontics Compared and Cleaning and Shaping in Adults
The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten
- Faculty Of Dentistry Ain Shams University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age: 20-50 years
- Medically free
- The patient should have the upper first premolar that needs endodontic treatment with apical periodontitis
- Necrotic teeth
- Participants were willing to commit to the entire period of the trial and agreed to sign the written consent after a full explanation of the study.
Exclusion Criteria:
- Symptomatic irreversible pulpitis
- If the premolar is non restorable
- If the premolar will need a post and core
- Vertical root fracture
- Open apex
- Presence of any systemic disease or allergic reactions.
- Vulnerable group; prisoners, pregnant females, mentally ill, etc…
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 |
|---|---|
|
Ingen indgriben: Control group
conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal
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|
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Aktiv komparator: Regeneration group
Cell homing via bleeding induction was done , MTA is applied into the canals at depth of 3mm and the access was sealed was composite restorations
|
it is done by bleeding induction into the canals
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Eksperimentel: Cleaning and shaping only group
Aseptic techniques were used while using irrigation activation technique to enhance the irrigation effects, after then MTA is applied into the canals at depth of 3mm and the access was sealed was composite restorations to ensure proper coronal seal
|
proper canal disinfection and mechanical instrumentation followed by proper coronal seal
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Resolution of the clinical and radiographic sign and symptoms
Tidsramme: follow ups 3, 6 12 months
|
clinically, no pain upon percussion , palpation and no sinus tracts signs of radiographic bone healing, it is going to be recorded as yes/ no answer No sign and symptoms= no pain upon percussion, palpation and no sinus tract was observed yes there is sign and symptoms= that one ore more of these criteria will be present [ pain upon percussion, presence of a bulge upon palpation, sinus tract exist] radiographic healing will be assessed by 2 ways
|
follow ups 3, 6 12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
restoring of the pulp vitality which will be recorded by electric pulp tester
Tidsramme: 3,6,12 months
|
the reading at each follow up will be yes/ no answer yes= there is sensation if the patient felt tingling while using the electric pulp tester no = no sensation if the patient didn't feel the tingling
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3,6,12 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
Nøgleord
Andre undersøgelses-id-numre
- 28/2/1993
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
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-
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