Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth

2. november 2020 opdateret af: Nourhan M.Aly

Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth (A Randomized Controlled Clinical Trial)

The aim of the present study is to assess clinically and radio-graphically the regenerative potential of immature permanent teeth with necrotic pulp using blood clot and Platelet rich fibrin scaffolds.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

30 immature necrotic permanent teeth in patients will be allocated and divided into two groups. Group 1 will be treated by regenerative procedure using blood clot as a scaffold and Group 2 will be treated with regenerative procedures using combined blood clot and Platelet rich fibrin as a scaffold.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Egypten
      • Alexandria, Egypten, 21512
        • Faculty of Dentistry, Alexandria University

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

8 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Necrotic incisors with immature roots
  • Pulp space not needed for post and core.
  • The patient has to be free from any coagulation disorders, with normal platelets count.
  • Good oral hygiene
  • Cooperative patient

Exclusion Criteria:

  • Internal or external root resorption.
  • Root fracture and/or alveolar fracture.
  • Previous root canal treatment.
  • Medically compromised patients
  • Uncooperative patient

Studieplan

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

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: Induced blood clot scaffold
Biologisk: Blood clot scaffold

Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction.

Biodentine will be placed approximately 3-4 mm below the cementoenamel junction.
Eksperimentel: Induced blood clot scaffold combined with Platelet rich fibrin
Biologisk: Blood clot scaffold combined with PRF
Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Subjective pain assessment
Tidsramme: 1 month
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
1 month
Subjective pain assessment
Tidsramme: 3 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
3 months
Subjective pain assessment
Tidsramme: 6 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
6 months
Subjective pain assessment
Tidsramme: 12 months
The patient will be asked about the presence of any pain or discomfort. Pain severity will be categorized as: no pain - mild pain - moderate pain - severe pain
12 months
Assessment of pulp vitality
Tidsramme: 1 month
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
1 month
Assessment of pulp vitality
Tidsramme: 3 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
3 months
Assessment of pulp vitality
Tidsramme: 6 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
6 months
Assessment of pulp vitality
Tidsramme: 12 months
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
12 months
Assessment of root development
Tidsramme: 1 month
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
1 month
Assessment of root development
Tidsramme: 3 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
3 months
Assessment of root development
Tidsramme: 6 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
6 months
Assessment of root development
Tidsramme: 12 months
Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
12 months
Assessment of the size of periapical radiolucency
Tidsramme: 1 month
Size of the lesion will be assessed using the periapical index score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
1 month
Assessment of the size of periapical radiolucency
Tidsramme: 1 month
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
1 month
Assessment of the size of periapical radiolucency
Tidsramme: 3 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
3 months
Assessment of the size of periapical radiolucency
Tidsramme: 3 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
3 months
Assessment of the size of periapical radiolucency
Tidsramme: 6 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
6 months
Assessment of the size of periapical radiolucency
Tidsramme: 6 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
6 months
Assessment of the size of periapical radiolucency
Tidsramme: 12 months
Size of the lesion will be assessed using the periapical index (PAI) score. The PAI provides an ordinal scale of 5 scores ranging from 1 (healthy) to 5 (severe periodontitis with exacerbating features).
12 months
Assessment of the size of periapical radiolucency
Tidsramme: 12 months
Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

Nourhan M.Aly

Samarbejdspartnere

Alexandria University

Efterforskere

  • Ledende efterforsker: Mahmoud MS Hassan, M.Sc, Faculty of Dentistry, Alexandria University, Egypt
  • Studieleder: Mohamed Ibrahim, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Studieleder: Sybel M Moussa, PhD, Faculty of Dentistry, Alexandria University, Egypt
  • Studiestol: Nihal A Lehita, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

6. juli 2018

Primær færdiggørelse (Faktiske)

20. januar 2020

Studieafslutning (Faktiske)

30. august 2020

Datoer for studieregistrering

Først indsendt

8. maj 2020

Først indsendt, der opfyldte QC-kriterier

14. maj 2020

Først opslået (Faktiske)

18. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • blood clot/ PRF & regeneration

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Pulp nekroser

Kliniske forsøg med Blood clot scaffold

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uzbekistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner