Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation (AA-IPRF-PDDG)
lauantai 31. lokakuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Tila
Ei vielä rekrytointia
Ehdot
Ehdot
Interventio / Hoito
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
Ilmoittautuminen
48
Vaihe
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
Opiskeluyhteys
- Nimi: Mahmoud Ebrahim El-Saadawy, BDS
- Puhelinnumero: +201000559354
- Sähköposti: mahmoudelsaadawy061293@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Mahmoud Ebrahim EL-Saadawy, BDS
- Puhelinnumero: +201007258261
- Sähköposti: mahmoudelsaadawy1993@gmail.com
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 60 vuotta (Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseiden lukumäärä
3
Aseet ja interventiot
Osallistujaryhmä / ArmOsallistujaryhmä / Arm |
Interventio / HoitoInterventio / Hoito |
|---|---|
|
Active Comparator: 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. |
|
Kokeellinen: 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. |
|
Kokeellinen: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Radiographic Horizontal Alveolar Ridge Width
Aikaikkuna: 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.
|
Toissijaiset tulostoimenpiteet
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Histomorphometric Analysis of Core Bone Biopsy Specimens
Aikaikkuna: 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.
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Sponsori
Tutkijat
Tutkijat
- Opintojen puheenjohtaja: Mohamed Sherif EL-Mofty, Professor, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
- Opintojohtaja: Shaimaa Hamdy Abd El-Azeem, : Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
Muut tutkimustunnusnumerot
- 00D-9-26-8
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
EI
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Ei
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .