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Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth LossAA-IPRF-PDDGNCT07916545

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

A study testing Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone, Alveolar Ridge Preservation Using PDDG Combined with I-PRF and Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF in people with Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss and Alveolar Bone Regeneration Following Odontectomy, run by Nahda University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone, Alveolar Ridge Preservation Using PDDG Combined with I-PRF and Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
30 Oct 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mahmoud Ebrahim El-Saadawy, BDS contact

+201000559354

mahmoudelsaadawy061293@gmail.com

Mahmoud Ebrahim EL-Saadawy, BDS contact

+201007258261

mahmoudelsaadawy1993@gmail.com

About this study

Official title: 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.

Read more

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.

Being tested
Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone, Alveolar Ridge Preservation Using PDDG Combined with I-PRF, Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF
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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft aloneProcedure or surgery

    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 Using PDDG Combined with I-PRFProcedure or surgery

    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.

  • Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRFProcedure or surgery

    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.

Study groups in NCT07916545
Study groupRoleWhat they receive
Partially Demineralized Dentin Graft AloneActive comparatorParticipants 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.
Receives: Procedure: Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone
Partially Demineralized Dentin Graft Combined with I-PRFExperimentalParticipants 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.
Receives: Procedure: Alveolar Ridge Preservation Using PDDG Combined with I-PRF
Ascorbic Acid-Loaded I-PRF Combined with PDDGExperimentalParticipants 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.
Receives: Procedure: Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2026
  2. Study start30 Oct 2026 (estimated)
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial (RCT) This study will be designed as a prospective, three-arm, parallel-group randomized controlled clinical trial. Group (1) Graft PDDG alone. Group (2) (PDDG) combined with(I-PRF); (Sticky Dentin). Group (3) Ascorbic Acid-loaded I-PRF combined with (PDDG); (AA-stick dentin).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07916545
Sponsor's protocol ID
00D-9-26-8
Acronym
AA-IPRF-PDDG
Status last verified
Oct 2026
First submitted
17 Oct 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Steigmann L, Di Gianfilippo R, Steigmann M, Wang HL. Classification Based on Extraction Socket Buccal Bone Morphology and Related Treatment Decision Tree. Materials (Basel). 2022 Jan 19;15(3):733. doi: 10.3390/ma15030733.

    PubMed 35160679
  • Fawzy El-Sayed KM, Nguyen N, Dorfer CE. Ascorbic Acid, Inflammatory Cytokines (IL-1beta/TNF-alpha/IFN-gamma), or Their Combination's Effect on Stemness, Proliferation, and Differentiation of Gingival Mesenchymal Stem/Progenitor Cells. Stem Cells Int. 2020 Aug 17;2020:8897138. doi: 10.1155/2020/8897138. eCollection 2020.

    PubMed 32879629
  • Heimes D, Schiegnitz E, Kuchen R, Kammerer PW, Al-Nawas B. Buccal Bone Thickness in Anterior and Posterior Teeth-A Systematic Review. Healthcare (Basel). 2021 Nov 30;9(12):1663. doi: 10.3390/healthcare9121663.

    PubMed 34946389
  • Castells-Mira E, Sanchez-Benito F, Alminana-Pastor PJ, Lopez-Roldan A. Radiographic and histomorphometric evaluation of Autogenous Particulated Dentin for Alveolar Ridge Preservation: A Systematic Review and Meta-analyses. J Clin Exp Dent. 2025 Oct 17;17(11):e1404-e1421. doi: 10.4317/jced.63147. eCollection 2025 Oct.

    PubMed 41466863
  • Alrmali A, Saleh MHA, Mazzocco J, Zimmer JM, Testori T, Wang HL. Auto-dentin platelet-rich fibrin matrix is an alternative biomaterial for different augmentation procedures: A retrospective case series report. Clin Exp Dent Res. 2023 Dec;9(6):993-1004. doi: 10.1002/cre2.808. Epub 2023 Nov 7.

    PubMed 37933487
  • Elbehwashy MT, Hosny MM, Elfana A, Nawar A, Fawzy El-Sayed K. Clinical and radiographic effects of ascorbic acid-augmented platelet-rich fibrin versus platelet-rich fibrin alone in intra-osseous defects of stage-III periodontitis patients: a randomized controlled clinical trial. Clin Oral Investig. 2021 Nov;25(11):6309-6319. doi: 10.1007/s00784-021-03929-1. Epub 2021 Apr 12.

    PubMed 33842996
  • Sherif MA, Anter E, Graetz C, El-Sayed KF. Injectable platelet-rich fibrin with vitamin C as an adjunct to non-surgical periodontal therapy in the treatment of stage-II periodontitis: a randomized controlled clinical trial. BMC Oral Health. 2025 May 23;25(1):772. doi: 10.1186/s12903-025-06115-x.

    PubMed 40410805
  • Tada A, Miura H. The Relationship between Vitamin C and Periodontal Diseases: A Systematic Review. Int J Environ Res Public Health. 2019 Jul 11;16(14):2472. doi: 10.3390/ijerph16142472.

    PubMed 31336735
  • Um IW, Kim YK, Mitsugi M. Demineralized dentin matrix scaffolds for alveolar bone engineering. J Indian Prosthodont Soc. 2017 Apr-Jun;17(2):120-127. doi: 10.4103/jips.jips_62_17.

    PubMed 28584412
  • Bertoldi C, Generali L, Cortellini P, Lalla M, Luppi S, Tomasi A, Zaffe D, Salvatori R, Bergamini S. Influence of Tooth-Brushing on Early Healing after Access Flap Surgery: A Randomized Controlled Preliminary Study. Materials (Basel). 2021 May 29;14(11):2933. doi: 10.3390/ma14112933.

    PubMed 34072369
  • Zhou LL, Yuan W, Zhang X, Chen L, Graetz C. Alveolar Ridge Preservation in Posterior Extraction Sockets: A Literature Review and Proposal of a Novel Therapeutic Classification. Clin Cosmet Investig Dent. 2026 Mar 20;18:584600. doi: 10.2147/CCIDE.S584600. eCollection 2026.

    PubMed 41909101
  • 1. Melek L, Marwan ES. 2016. Evaluation of "Autogenous Bioengineered Injectable PRF-Tooth Graft" Combination (ABIT) in Reconstruction of Maxillary Alveolar Ridge Defects. Saudi J Dent Res. 8:86-96.

  • Cagetti MG, Wolf TG, Tennert C, Camoni N, Lingstrom P, Campus G. The Role of Vitamins in Oral Health. A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2020 Feb 3;17(3):938. doi: 10.3390/ijerph17030938.

    PubMed 32028631
  • Binderman I, Hallel G, Nardy C, Yaffe A, Sapoznikov L. A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscip Med Dent Sci. 2014;2:154.

  • Mani A, Mani S, Sachdeva S, Sodhi JK, Vora HR, Gholap S. 2021. Post-Surgical Care in Surgical Periodontics. Int J Periodontol Implantol. 6:74-78.

Questions about this trial

What is this clinical trial studying?

A study testing Alveolar Ridge Preservation Using Partially Demineralized Dentin Graft alone, Alveolar Ridge Preservation Using PDDG Combined with I-PRF and Alveolar Ridge Preservation Using PDDG Combined with Ascorbic Acid-Loaded I-PRF in people with Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss and Alveolar Bone Regeneration Following Odontectomy, run by Nahda University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud Ebrahim El-Saadawy, BDS (+201000559354, mahmoudelsaadawy061293@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Radiographic Horizontal Alveolar Ridge Width (time frame: Baseline (before alveolar ridge preservation) to 4 months postoperatively.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07916545, which also lists 59 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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