Efficacy of Combined Blood Clot and Platelet Rich Fibrin Scaffolds in Regeneration of Necrotic Immature Permanent Teeth
2. november 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alexandria, Egypt, 21512
- Faculty of Dentistry, Alexandria University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
8 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Induced blood clot scaffold
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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. |
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Eksperimentell: Induced blood clot scaffold combined with Platelet rich fibrin
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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1 month
|
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Subjective pain assessment
Tidsramme: 3 months
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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
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3 months
|
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Subjective pain assessment
Tidsramme: 6 months
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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
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6 months
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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
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12 months
|
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Assessment of pulp vitality
Tidsramme: 1 month
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Pulp vitality will be assessed using thermal and electric pulp sensibility tests
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1 month
|
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Assessment of pulp vitality
Tidsramme: 3 months
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Pulp vitality will be assessed using thermal and electric pulp sensibility tests
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3 months
|
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Assessment of pulp vitality
Tidsramme: 6 months
|
Pulp vitality will be assessed using thermal and electric pulp sensibility tests
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6 months
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Assessment of pulp vitality
Tidsramme: 12 months
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Pulp vitality will be assessed using thermal and electric pulp sensibility tests
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12 months
|
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Assessment of root development
Tidsramme: 1 month
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Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
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1 month
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Assessment of root development
Tidsramme: 3 months
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Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
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3 months
|
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Assessment of root development
Tidsramme: 6 months
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Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
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6 months
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Assessment of root development
Tidsramme: 12 months
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Continued root development will be assessed using cone beam computed tomography (CBCT) and compared with the contra-lateral healthy tooth
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12 months
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Assessment of the size of periapical radiolucency
Tidsramme: 1 month
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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).
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1 month
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Assessment of the size of periapical radiolucency
Tidsramme: 1 month
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Size of the lesion will be assessed using Cone Beam Computed Tomography (CBCT).
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1 month
|
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Assessment of the size of periapical radiolucency
Tidsramme: 3 months
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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).
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3 months
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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).
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12 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: 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
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Bakhtiar H, Vatanpour M, Rayani A, Navi F, Asna-Ashari E, Ahmadi A, Jafarzadeh H. The plasma-rich in growth factor as a suitable matrix in regenerative endodontics: a case series. N Y State Dent J. 2014 Jun-Jul;80(4):49-53.
- Keswani D, Pandey RK. Revascularization of an immature tooth with a necrotic pulp using platelet-rich fibrin: a case report. Int Endod J. 2013 Nov;46(11):1096-104. doi: 10.1111/iej.12107. Epub 2013 Apr 13.
- Yassen GH, Eckert GJ, Platt JA. Effect of intracanal medicaments used in endodontic regeneration procedures on microhardness and chemical structure of dentin. Restor Dent Endod. 2015 May;40(2):104-12. doi: 10.5395/rde.2015.40.2.104. Epub 2014 Dec 24.
- Yassen GH, Sabrah AH, Eckert GJ, Platt JA. Effect of different endodontic regeneration protocols on wettability, roughness, and chemical composition of surface dentin. J Endod. 2015 Jun;41(6):956-60. doi: 10.1016/j.joen.2015.02.023. Epub 2015 Mar 29.
- Neha K, Kansal R, Garg P, Joshi R, Garg D, Grover HS. Management of immature teeth by dentin-pulp regeneration: a recent approach. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e997-1004. doi: 10.4317/medoral.17187.
- Lovelace TW, Henry MA, Hargreaves KM, Diogenes A. Evaluation of the delivery of mesenchymal stem cells into the root canal space of necrotic immature teeth after clinical regenerative endodontic procedure. J Endod. 2011 Feb;37(2):133-8. doi: 10.1016/j.joen.2010.10.009.
- Cotti E, Mereu M, Lusso D. Regenerative treatment of an immature, traumatized tooth with apical periodontitis: report of a case. J Endod. 2008 May;34(5):611-6. doi: 10.1016/j.joen.2008.02.029.
- Cehreli ZC, Isbitiren B, Sara S, Erbas G. Regenerative endodontic treatment (revascularization) of immature necrotic molars medicated with calcium hydroxide: a case series. J Endod. 2011 Sep;37(9):1327-30. doi: 10.1016/j.joen.2011.05.033. Epub 2011 Jul 13.
- Law AS. Considerations for regeneration procedures. J Endod. 2013 Mar;39(3 Suppl):S44-56. doi: 10.1016/j.joen.2012.11.019.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. juli 2018
Primær fullføring (Faktiske)
20. januar 2020
Studiet fullført (Faktiske)
30. august 2020
Datoer for studieregistrering
Først innsendt
8. mai 2020
Først innsendt som oppfylte QC-kriteriene
14. mai 2020
Først lagt ut (Faktiske)
18. mai 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Stomatognatiske sykdommer
- Embolisme og trombose
- Tannsykdommer
- Tannmassesykdommer
- Nekrose
- Trombose
- Dental Pulp Nekrose
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler, lokale
- Anti-infeksjonsmidler
- Enzymhemmere
- Hormoner, hormonsubstitutter og hormonantagonister
- Cytokrom P-450 CYP3A-hemmere
- Cytokrom P-450 enzymhemmere
- Hormonantagonister
- Antifungale midler
- Steroidesyntesehemmere
- 14-alfa-demetylasehemmere
- Cytokrom P-450 CYP2C9-hemmere
- Klotrimazol
- Mikonazol
Andre studie-ID-numre
- blood clot/ PRF & regeneration
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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