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Vital Pulp Therapy to Treat Irreversible Pulpitis (VPT)

26. april 2017 opdateret af: Saeed Asgary, Shahid Beheshti University of Medical Sciences

Pulpotomy Versus Root Canal Therapy to Treat Irreversible Pulpitis in Human Permanent Molars: A Multicenter Randomized Non-inferiority Trial.

The purpose of this study is to demonstrate non-inferiority of pulpotomy treatment (with new endodontic bio-materials) as a new treatment with one-visit root canal therapy as reference treatment in pain relief and clinical and radiographic success, for irreversible pulpitis of human permanent molar teeth.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In one visit RCT (Arm 1): The teeth were anesthetized, isolated and endodontic access and instrumentation of all canals was done. Canal preparation was conducted using a step-back technique. The working lengths were determined and confirmed by radiography. Sterile normal saline solution was used for intra-canal irrigation. Root canals were obturated with gutta-percha and sealer using lateral condensation technique. After placing a cotton pellet in the pulp chamber, the access cavity was closed with Cavit.

In pulpotomy treatment with CEM/MTA (Arm 2): The teeth were anesthetized. Pulpotomy procedure of removing inflamed pulp tissue to the stump level was done. Homeostasis was achieved by irrigating the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The pulpal wound was covered with an approximately 2-mm-thick layer of MTA/CEM cement. Pulp chambers were then covered with a wet cotton pellet and sealed with Cavit.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

615

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnostic criteria:

    1. Patient reports pain of endodontic origin
    2. Diagnosis of irreversible pulpitis

  • Eligibility criteria:

    1. Molar tooth
    2. Patient chooses to have tooth extraction for pain relief
    3. Age 9-65 years
    4. Both gender
    5. The patient had read and thoroughly understood the questionnaires; and
    6. Written informed consent

  • Exclusion Criteria:

    1. Moderate or severe periodontitis
    2. None restorable tooth
    3. Internal or external root resorption
    4. Root canal calcification
    5. No bleeding after access cavity preparation
    6. Analgesic taken within the last 4 h
    7. Active systemic disease
    8. The patient was pregnant or nursing
    9. History of opioid addiction or abuse
    10. Temporary residency

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
ORCT
Procedure: One-visit root canal therapy
Teeth were isolated, caries was removed and access cavities were prepared. Canal preparation was conducted using step-back technique. The working lengths were determined and confirmed by radiographs. The minimum size file for preparing the working length was size ISO #25 K-file to within 0.5-2 mm of the radiographic apex of the root. During hand instrumentation, canals were frequently irrigated with adequate amount of sterile normal saline solution. The root canals were filled with multiple gutta-percha cones and sealer using lateral condensation technique. Placing a cotton pellet in the pulp chamber, the access cavity was temporarily filled. The treatments of all samples were performed one-visit.
Andre navne:
  • single-visit RCT
Eksperimentel: 2
PCEM/PMTA
Procedure: pulpotomy
Pulpotomy was performed with a large round bur in a high-speed handpiece with copious irrigation; removing inflamed pulp tissue to stump level. Hemostasis was achieved by irrigation of the cavity with sterile normal saline and application of small pieces of sterile cotton pellets. The blood clot-free pulpal wound was covered with approximately 2 mm layer of endodontic bio-materials, a sterile wet cotton pellet was then placed over the MTA/CEM cement and the cavity sealed with Cavit.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Clinical and radiographical success of pulpotomy with CEM cement
Tidsramme: 5 year
5 year

Sekundære resultatmål

Resultatmål
Tidsramme
Patient Assessment of Pain - Visual Analogue Scale
Tidsramme: 7 day
7 day

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shahid Beheshti University of Medical Sciences

Efterforskere

  • Studieleder: Mohammad Jafar Eghbal, Prof., Shahid Beheshti University of Medical Sciences
  • Ledende efterforsker: Jamileh Ghoddusi, Prof., Mashhad University of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2008

Primær færdiggørelse (Faktiske)

1. september 2008

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

4. september 2008

Først indsendt, der opfyldte QC-kriterier

4. september 2008

Først opslået (Skøn)

8. september 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • C/B/4/8253

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 Pulpitis

Kliniske forsøg med One-visit root canal therapy

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