- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07609732
Outcomes of Conventional Root Canal Treatment Compared to Regenerative Endodontics, and Cleaning and Shaping Only in Mature Upper First Premolars
The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten
- Faculty Of Dentistry Ain Shams University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control group
conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal
|
|
|
Aktiv komparator: Regeneration group
Cell homing via bleeding induction was done, MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer, then composite restorations were placed
|
it is done by bleeding induction into the canals
|
|
Experimentell: Cleaning and shaping only group
Aseptic techniques were used while using the irrigation activation technique to enhance the irrigation effects, after then MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer then composite restorations were placed to ensure proper coronal seal
|
proper canal disinfection and mechanical instrumentation followed by proper coronal seal
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Resolution of the clinical and radiographic sign and symptoms
Tidsram: follow ups 3, 6 12 months
|
Clinically, no pain upon percussion or palpation, and no sinus tracts. Signs of radiographic bone healing it is going to be recorded as a yes/ no answer. No sign and symptoms= no pain upon percussion, palpation, and no sinus tract was observed Yes, there are signs and symptoms= that one or more of these criteria will be present [ pain upon percussion, presence of a bulge upon palpation, sinus tract exists] Radiographic healing will be assessed by 2 ways.
|
follow ups 3, 6 12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
restoring of the pulp vitality which will be recorded by electric pulp tester
Tidsram: 3,6,12 months
|
The reading at each follow-up will be a yes/ no answer Yes, there is sensation if the patient feels tingling while using the electric pulp tester No, no sensation if the patient didn't feel the tingling
|
3,6,12 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
Nyckelord
Andra studie-ID-nummer
- 28/2/1993
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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