Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation (AA-IPRF-PDDG)
31 octobre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
48
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Mahmoud Ebrahim El-Saadawy, BDS
- Numéro de téléphone: +201000559354
- E-mail: mahmoudelsaadawy061293@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Mahmoud Ebrahim EL-Saadawy, BDS
- Numéro de téléphone: +201007258261
- E-mail: mahmoudelsaadawy1993@gmail.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 60 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Radiographic Horizontal Alveolar Ridge Width
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Histomorphometric Analysis of Core Bone Biopsy Specimens
Délai: 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.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Mohamed Sherif EL-Mofty, Professor, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
- Directeur d'études: Shaimaa Hamdy Abd El-Azeem, : Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 octobre 2026
Achèvement primaire (Estimé)
30 mars 2027
Achèvement de l'étude (Estimé)
30 juin 2027
Dates d'inscription aux études
Première soumission
17 octobre 2026
Première soumission répondant aux critères de contrôle qualité
31 octobre 2026
Première publication (Réel)
4 novembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 novembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
31 octobre 2026
Dernière vérification
1 octobre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 00D-9-26-8
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .