Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation (AA-IPRF-PDDG)
31 oktober 2026 bijgewerkt door: Mahmoud Ebrahim Ahmed Elsaadawy, Nahda University
Effect of Ascorbic Acid-Loaded Injectable Platelet-Rich Fibrin Combined With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to find out which treatment best preserves the jawbone after tooth extraction in adults planning to receive a dental implant later.
The study will investigate whether adding vitamin C to a mixture of tooth particles and a material prepared from the participant's own blood helps preserve the jawbone and improve bone healing.
The main questions it aims to answer are
- Does adding vitamin C help preserve the width of the jawbone after tooth extraction?
- Does it improve new bone formation compared with the other treatments?
Researchers will compare three treatments to determine whether adding a blood-based material, with or without vitamin C, improves bone preservation.
- The first group will receive small particles prepared from their own extracted tooth.
- The second group will receive tooth particles mixed with a healing material prepared from their own blood.
- The third group will receive tooth particles mixed with the same blood-based material containing vitamin C.
Participants will undergo tooth extraction and receive one of these treatments. They will attend follow-up visits during the healing period.
Researchers will:
- Examine the treated area during follow-up visits.
- Take three-dimensional dental scans before treatment and four months later to measure changes in jawbone width and height.
- Collect a small bone sample during dental implant placement to examine new bone formation and healing.
The study will help determine whether adding vitamin C to the blood-based material provides additional benefits for preserving the jawbone before dental implant placement.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Gedetailleerde beschrijving
This study evaluates approaches to preserve the alveolar ridge following tooth extraction before delayed dental implant placement.
The study uses a partially demineralized dentin graft prepared from the participant's extracted tooth as the grafting material. It also investigates whether combining this graft with injectable platelet-rich fibrin (I-PRF), with or without added ascorbic acid (vitamin C), may influence bone healing and ridge preservation.
The rationale for using dentin is based on its potential as an autologous graft material. I-PRF provides an autologous blood-derived component. The addition of vitamin C is being investigated as a possible way to influence the healing response.
The study will assess changes in alveolar ridge dimensions and examine bone tissue collected during implant placement. Histological and histomorphometric analysis will help characterize new bone formation, residual graft material, and connective tissue within the healing site.
The findings may provide information about the role of vitamin C-enriched I-PRF when combined with autogenous dentin grafts for alveolar ridge preservation.
Studietype
Ingrijpend
Inschrijving (Geschat)
48
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Mahmoud Ebrahim El-Saadawy, BDS
- Telefoonnummer: +201000559354
- E-mail: mahmoudelsaadawy061293@gmail.com
Studie Contact Back-up
- Naam: Mahmoud Ebrahim EL-Saadawy, BDS
- Telefoonnummer: +201007258261
- E-mail: mahmoudelsaadawy1993@gmail.com
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 60 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patients aged 18-60 years. ⁴⁷
- ASA Type I medically healthy patients with no significant medical history. ⁴⁷
- Non-restorable teeth indicated for extraction followed by delayed implant placement. ⁴⁸
- Patients eligible for immediate implant placement but facing factors that prevent implant placement at the time of extraction. ⁴⁸
- Patients requiring alveolar ridge preservation before planned dental implant placement.
- Presence of ST IB sockets after extraction. ⁴²-⁴⁴
- periodontally healthy adjacent teeth. ⁴⁸
- Adequate oral hygiene plaque index ≤15% and willingness to comply with the study protocol and follow-up visits. ⁴⁷
- Cooperative patients willing to comply with the 4-month follow-up period. ⁴⁷
- Ability to understand and sign the informed consent form. ⁴⁷
Exclusion Criteria:
- Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus).
- History of radiotherapy or chemotherapy involving the head and neck region.
- Current use of medications known to influence bone metabolism (e.g., bisphosphonates, denosumab, long-term corticosteroids).
- Smokers or tobacco users.
- Pregnancy or lactation.
- Acute uncontrolled infection extraction site.
- Patients with poor oral hygiene or untreated active periodontal disease.
- Psychiatric patients, or those with a learning disability, or those unable to give consent
- Patients unable or unwilling to attend follow-up visits.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Partially Demineralized Dentin Graft Alone
Participants will undergo alveolar ridge preservation following atraumatic tooth extraction using an autogenous partially demineralized dentin graft (PDDG) prepared from the extracted tooth. The graft will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. No injectable platelet-rich fibrin (I-PRF) or ascorbic acid will be added. |
Alveolar ridge preservation following atraumatic tooth extraction using an autogenous partially demineralized dentin graft (PDDG) prepared from the extracted tooth. The graft will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. No injectable platelet-rich fibrin (I-PRF) or ascorbic acid will be added. |
|
Experimenteel: Partially Demineralized Dentin Graft Combined with I-PRF
Participants will undergo alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) prepared from the participant's peripheral blood. The resulting mixture, referred to as Sticky Dentin, will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
Alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) prepared from the participant's peripheral blood. The resulting sticky dentin mixture will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
|
Experimenteel: Ascorbic Acid-Loaded I-PRF Combined with PDDG
Participants will undergo alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) containing ascorbic acid. The resulting mixture, referred to as AA-Sticky Dentin, will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
Alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) containing ascorbic acid. The resulting AA-Sticky Dentin mixture will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Radiographic Horizontal Alveolar Ridge Width
Tijdsspanne: Baseline (before alveolar ridge preservation) to 4 months postoperatively.
|
The change in horizontal alveolar ridge width will be assessed using cone-beam computed tomography (CBCT) scans obtained at baseline before alveolar ridge preservation and 4 months postoperatively. Measurements will be performed at the extraction site using standardized anatomical reference points and consistent measurement procedures. The change in ridge width from baseline to 4 months will be compared among the three study groups. |
Baseline (before alveolar ridge preservation) to 4 months postoperatively.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Histomorphometric Analysis of Core Bone Biopsy Specimens
Tijdsspanne: 4 months after alveolar ridge preservation, during implant osteotomy. 4 months after alveolar ridge preservation, during implant osteotomy.
|
Histomorphometric analysis will be performed on core bone biopsy specimens collected from the alveolar ridge preservation sites during implant osteotomy 4 months postoperatively. The analysis will assess the percentages of newly formed bone, mature bone, and residual dentin graft particles in the specimens, and the results will be compared among the three study groups. |
4 months after alveolar ridge preservation, during implant osteotomy. 4 months after alveolar ridge preservation, during implant osteotomy.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie stoel: Mohamed Sherif EL-Mofty, Professor, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
- Studie directeur: Shaimaa Hamdy Abd El-Azeem, : Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 oktober 2026
Primaire voltooiing (Geschat)
30 maart 2027
Studie voltooiing (Geschat)
30 juni 2027
Studieregistratiedata
Eerst ingediend
17 oktober 2026
Eerst ingediend dat voldeed aan de QC-criteria
31 oktober 2026
Eerst geplaatst (Werkelijk)
4 november 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 november 2026
Laatste update ingediend die voldeed aan QC-criteria
31 oktober 2026
Laatst geverifieerd
1 oktober 2026
Meer informatie
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Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 00D-9-26-8
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared with other researchers. Only aggregated study results may be disseminated through scientific publications, while participant confidentiality and data privacy will be maintained in accordance with institutional ethical requirements.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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