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Not yet recruitingNCT07916545AA-IPRF-PDDGUpdated Nov 4, 2026

Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation

An interventional study of Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone and Alveolar Ridge Preservation Using PDDG Combined with I-PRF in Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy and Assisted Alveolar Bone Healing After Dental Extraction, sponsored by Nahda University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Nahda University · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

  1. The first group will receive small particles prepared from their own extracted tooth.
  2. The second group will receive tooth particles mixed with a healing material prepared from their own blood.
  3. 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.

Read the detailed description

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.

02

Conditions studied

  • Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss
  • Alveolar Bone Regeneration Following Odontectomy
  • Assisted Alveolar Bone Healing After Dental Extraction
  • Alveolar Bone Preservation

Browse trials for

Keywords

  • Alveolar Ridge Preservation
  • autogenous graft materials
  • Partially Demineralized Dentin Graft
  • autogenous particulate dentin
  • Sticky Dentin
  • Ascorbic Acid-loaded I-PRF
  • assisted alveolar bone healing post extraction
03

In context

Tooth Loss

165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.

This study's planned enrollment of 48 is above the median of 30 across 120 interventional studies indexed under Tooth Loss.

Browse Tooth Loss studies →

Lead sponsor

Nahda University is the lead sponsor of 8 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form. ⁴⁷

Exclusion criteria

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 ).
  • 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • 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.

    Procedure: Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone

  • 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.

    Procedure: Alveolar Ridge Preservation Using PDDG Combined with I-PRF

  • 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.

    Procedure: Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF

Interventions

  • ProcedureAlveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone

    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.

  • ProcedureAlveolar Ridge Preservation Using PDDG Combined with I-PRF

    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.

  • ProcedureAlveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF

    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.

06

What researchers measure

Primary outcomes

  1. Change in Radiographic Horizontal Alveolar Ridge Width

    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.

    Time frame: Baseline (before alveolar ridge preservation) to 4 months postoperatively.

Secondary outcomes

  1. Histomorphometric Analysis of Core Bone Biopsy Specimens

    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.

    Time frame: 4 months after alveolar ridge preservation, during implant osteotomy. 4 months after alveolar ridge preservation, during implant osteotomy.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

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  • Stumbras A, Kuliesius P, Januzis G, Juodzbalys G. Alveolar Ridge Preservation after Tooth Extraction Using Different Bone Graft Materials and Autologous Platelet Concentrates: a Systematic Review. J Oral Maxillofac Res. 2019 Mar 31;10(1):e2. doi: 10.5037/jomr.2019.10102. eCollection 2019 Jan-Mar. PubMed 31069040 ↗
  • Avila-Ortiz G, Couso-Queiruga E, Stuhr S, Chambrone L. Long-term outcomes of post-extraction alveolar ridge preservation and alveolar ridge reconstruction followed by delayed implant placement: A systematic review. Periodontol 2000. 2025 Jul 3. doi: 10.1111/prd.12642. Online ahead of print. PubMed 40605823 ↗
  • Allen HT, Zellner JW, Kotsakis GA, Mealey BL. Long-term preservation of ridge dimension following tooth extraction and ridge preservation: A randomized controlled trial of healing at 4- and 12-month healing time points. J Periodontol. 2022 Aug;93(8):1183-1190. doi: 10.1002/JPER.21-0607. Epub 2022 Feb 21. PubMed 35044692 ↗
  • Couso-Queiruga E, Stuhr S, Tattan M, Chambrone L, Avila-Ortiz G. Post-extraction dimensional changes: A systematic review and meta-analysis. J Clin Periodontol. 2021 Jan;48(1):126-144. doi: 10.1111/jcpe.13390. Epub 2020 Nov 4. PubMed 33067890 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07916545
Lead sponsor
Nahda University
Responsible party
Mahmoud Ebrahim Ahmed Elsaadawy (Master's Candidate, Nahda University) — Principal investigator
First posted
Nov 4, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Mahmoud Ebrahim El-Saadawy, BDS
Contact
mahmoudelsaadawy061293@gmail.com
+201000559354
Mahmoud Ebrahim EL-Saadawy, BDS
Contact
mahmoudelsaadawy1993@gmail.com
+201007258261
Mohamed Sherif EL-Mofty, Professor
study chair · Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
Shaimaa Hamdy Abd El-Azeem
study director · : Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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