- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07798206
Comparison Between Dentine Autograft VS Platelet Rich Fibrin in Extraction Socket Bone Healing
27. august 2026 opdateret af: Eman abdelbaki, Cairo University
Histomorphological Evaluation of Alveolar Bone Healing Using Dentin Autograft Mixed With Platelet-rich Fibrin in Extraction Socket vs Graftless Healing
The present study will be performed to:
evaluate alveolar bone healing using dentin autograft mixed with platelet-rich plasma in extraction socket vs graftless healing.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
When teeth are extracted, a certain amount of bone loss or resorption occurs, usually about 30-60%.
This loss is typically three-dimensional in nature, with width loss or horizontal deficiency developing to a greater extent than other types of deficiencies.
An alveolar defect can be classified as the loss of labial or buccal cortical or medullary bone.
In some cases, both exist.
Although all alveolar defects present challenges when planning a dental implant procedure, if the defect is in the buccal cortex or cortical plate after tooth extraction, this can create significant difficulties in the reconstruction of a dental implant.
Bone loss or bone augmentation techniques have been developed to counteract alveolar defects, such as guided bone regeneration, onlay block bone grafting, ridge/split bone grafting, and alveolar distraction osteogenesis.
These procedures can help improve an alveolar defect and prepare the alveolar ridge for a successful dental implant.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
45
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Cairo Governorate
-
Cairo, Cairo Governorate, Egypten, 11553
- Faculty of Dentistry, Cairo University
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-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- 1. Patients with hopeless non molar teeth that need extraction. 2. Age above 18 years. 3. Generally good state of health. 4. Agreement to participate in the study and also have to be able to attend postoperative clinical and radiological follow-up 6. Acquisition of informed consent.
Exclusion Criteria:
1- Patients refuse to be enrolled in this study
2- Patients with uncontrolled systemic disease.
3- Previously diagnosed hematological and neurological conditions.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Graftless Healing (Control)
Participants undergo atraumatic extraction of a hopeless non-molar tooth.
The extraction socket is left to heal spontaneously without placement of any grafting material.
The socket is sutured with 3-0 Vicryl to allow primary wound closure.
Clinical, radiographic, and histomorphometric evaluations are performed according to the study follow-up schedule.
|
|
|
Eksperimentel: Autogenous Dentin Graft Mixed with Platelet-Rich Plasma (PRP)
Participants undergo atraumatic extraction of a hopeless non-molar tooth followed by immediate socket preservation using an autogenous dentin graft prepared from the extracted tooth.
The dentin particles are processed using the Smart Dentin Grinder system, disinfected, rinsed with phosphate-buffered saline, and mixed with autologous platelet-rich plasma (PRP) to produce a sticky dentin graft.
The graft is placed into the extraction socket, and the surgical site is sutured with 3-0 Vicryl.
Clinical, radiographic, and histomorphometric outcomes are evaluated throughout the follow-up period.
|
DENTION IS HARVESTED FROM NON RESTORABLE TOOTH TO BE GROUND AND MIXED WITH PRF TO BE APPLIED IN EXTRACTION SOCKETS < 1ST GROUP> PRF IS WITHDROWN FROM BLOOD AND CENTRIFUGED TO FORM A GRAFT TO BE APPLIED IN EXTRACTION SOCKETS <2ND GROUP> EXTRACTION SOCKETS ARE LEFT TO HEAL SPONTANUOUSLY
|
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Eksperimentel: Platelets rich fibrin applied in the socket
PRF from patient own blood is applied to the socket
|
DENTION IS HARVESTED FROM NON RESTORABLE TOOTH TO BE GROUND AND MIXED WITH PRF TO BE APPLIED IN EXTRACTION SOCKETS < 1ST GROUP> PRF IS WITHDROWN FROM BLOOD AND CENTRIFUGED TO FORM A GRAFT TO BE APPLIED IN EXTRACTION SOCKETS <2ND GROUP> EXTRACTION SOCKETS ARE LEFT TO HEAL SPONTANUOUSLY
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Histomorphometric bone formation (%)
Tidsramme: 3-6 months
|
a trephine bur is used to extract a sample from healed bone to be stained with H&E and analyzed under microscope
|
3-6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bone density (radiographic) Healing index
Tidsramme: 3-6 months
|
type of bone is measerd on cbct scan after three months from healing of bone
|
3-6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. januar 2023
Primær færdiggørelse (Faktiske)
13. januar 2026
Studieafslutning (Faktiske)
1. juli 2026
Datoer for studieregistrering
Først indsendt
27. august 2026
Først indsendt, der opfyldte QC-kriterier
27. august 2026
Først opslået (Faktiske)
1. september 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Dentine autograft vs PRF
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Individual participant data (IPD) will not be shared because the study was not designed with participant-level data sharing.
The collected data contain confidential information, and participants did not provide consent for public sharing of de-identified individual-level data.
Only aggregate study results will be published.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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