Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation (AA-IPRF-PDDG)
31. Oktober 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Geschätzt)
48
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Mahmoud Ebrahim El-Saadawy, BDS
- Telefonnummer: +201000559354
- E-Mail: mahmoudelsaadawy061293@gmail.com
Studieren Sie die Kontaktsicherung
- Name: Mahmoud Ebrahim EL-Saadawy, BDS
- Telefonnummer: +201007258261
- E-Mail: mahmoudelsaadawy1993@gmail.com
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Radiographic Horizontal Alveolar Ridge Width
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Histomorphometric Analysis of Core Bone Biopsy Specimens
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Mohamed Sherif EL-Mofty, Professor, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
- Studienleiter: Shaimaa Hamdy Abd El-Azeem, : Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
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Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
30. Oktober 2026
Primärer Abschluss (Geschätzt)
30. März 2027
Studienabschluss (Geschätzt)
30. Juni 2027
Studienanmeldedaten
Zuerst eingereicht
17. Oktober 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. Oktober 2026
Zuerst gepostet (Tatsächlich)
4. November 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. November 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
31. Oktober 2026
Zuletzt verifiziert
1. Oktober 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 00D-9-26-8
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .