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Tooth ExtractionARF-PRFNCT07789262

Autogenous Dentin Graft for Alveolar Ridge Preservatio

A study testing Autogenous Dentin Graft, Platelet-Rich Fibrin (PRF) and Freeze-Dried Bone Allograft (FDBA) in people with Tooth Extraction and Alveolar Bone Loss, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

When a tooth is extracted, the bone around the empty socket naturally shrinks over time, which can make it difficult to place a dental implant later without additional bone-building procedures. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tooth Extraction, Alveolar Bone Loss
What is being tested?
Autogenous Dentin Graft, Platelet-Rich Fibrin (PRF) and Freeze-Dried Bone Allograft (FDBA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2023to 8 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Systemically healthy individuals (ASA I-II)
  • Age 18 years or older
  • Presence of a tooth requiring extraction, radiographically confirmed to be non-infected

Who cannot join

  • Presence of acute infection at the extraction site
  • Advanced systemic disease
  • Use of medications known to affect bone metabolism
  • Current smoking or alcohol use
  • Anticipated non-compliance with scheduled follow-up visits

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ankara Yıldırım Beyazıt University, Faculty of Dentistry

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Clinical and Histological Evaluation of the Efficacy of Autogenous Dentin Graft in Extraction Socket Preservation

When a tooth is extracted, the bone around the empty socket naturally shrinks over time, which can make it difficult to place a dental implant later without additional bone-building procedures. This study investigated whether grafting the socket with the patient's own extracted tooth material, processed into a graft (autogenous dentin graft), can help preserve this bone. The study also examined whether adding platelet-rich fibrin (PRF), a concentrate prepared from the patient's own blood that is rich in healing factors, could further improve outcomes. A total of 56 extraction sockets were randomly assigned to one of four treatment approaches: no grafting (natural healing), dentin graft alone, dentin graft combined with PRF, or a freeze-dried bone allograft, which is a commonly used bone substitute for comparison. Four months after treatment, small bone samples were taken from each site at the time of dental implant placement and examined under the microscope to measure how much new bone had formed, along with other markers of healing such as blood vessel formation and a bone-growth protein called BMP-2. The results showed that sockets treated with dentin graft healed at least as well as those treated with the standard bone substitute, and that combining dentin graft with PRF produced the best healing results of all groups tested. These findings suggest that a patient's own extracted tooth, which would otherwise be discarded, may serve as an effective and low-cost graft material for preserving bone after tooth extraction, particularly when combined with PRF.

Read the detailed description

Following tooth extraction, the alveolar ridge undergoes progressive dimensional changes, primarily due to bundle bone resorption, which may compromise the volume and quality of bone available for future implant placement. Alveolar ridge preservation (ARP) procedures aim to minimize this resorption through the use of various grafting materials.

This prospective, randomized, controlled clinical trial was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Ankara Yıldırım Beyazıt University. Eligible participants were systemically healthy individuals aged ≥18 years (ASA I-II) who required extraction of a radiographically non-infected tooth. Patients with acute infection at the extraction site, advanced systemic disease, use of medications affecting bone metabolism, smoking or alcohol consumption, or anticipated non-compliance with follow-up visits were excluded.

A total of 56 extraction sockets from nine patients (six women and three men; age range, 24-55 years) were randomly allocated into four groups: Control (spontaneous healing without grafting, n = 13), Dentin (grafted with autogenous dentin particles, n = 14), Dentin + PRF (grafted with autogenous dentin combined with leukocyte- and platelet-rich fibrin, n = 15), and FDBA (grafted with freeze-dried bone allograft, n = 14). All surgical procedures were performed by the same operator to eliminate inter-operator variability.

The sample size was calculated using G*Power version 3.1.9.6 (Universität Kiel, Germany), based on a repeated-measures ANOVA design, an effect size of 0.20, a statistical power of 80%, and an alpha level of 0.05. The analysis indicated that a minimum of 52 extraction sockets (13 per group) was required.

Autogenous dentin grafts were prepared immediately after extraction according to the method described by Binderman et al. Soft-tissue remnants, enamel, and cementum were removed from the extracted teeth using a tungsten carbide bur under water cooling. The cleaned teeth were processed using a Smart Dentin Grinder (KometaBio, Israel) to obtain particulate graft material with a particle size of 300-1200 µm. The particles were subsequently disinfected for 10 min in a solution containing 20% ethanol and 0.5 M NaOH and rinsed with a buffered saline solution to neutralize the pH before graft placement.

For the Dentin + PRF group, platelet-rich fibrin was prepared from 10 mL of venous blood collected in sterile tubes without anticoagulant and centrifuged at approximately 2700-3000 rpm for 10-12 min according to the Choukroun protocol. The resulting PRF clot was compressed into a membrane, cut into small fragments, and homogeneously mixed with the dentin particles before placement into the extraction sockets.

Full-thickness mucoperiosteal flaps were elevated as required in the Dentin and Dentin + PRF groups, and the graft materials were adapted to ensure close contact with the socket walls. In the FDBA group, the commercially available allograft was placed with minimal or no flap elevation. In the Control group, the extraction sockets were allowed to heal spontaneously through blood clot formation without graft placement or flap surgery. The flaps were closed using 3-0 silk sutures. In selected cases in which primary closure could not be achieved, a free gingival graft was used as a "socket seal." Postoperative care consisted of a standard antibiotic regimen (amoxicillin/clavulanic acid, 1000 mg twice daily for 7 days), an NSAID analgesic, and a chlorhexidine/benzydamine mouth rinse. Sutures were removed on postoperative day 10, and patients were followed clinically at monthly intervals.

Four months after grafting, at the time of dental implant placement, cylindrical bone-core biopsies were obtained from the treated alveolar ridge using a trephine bur. Specimens were fixed in 10% neutral buffered formalin, decalcified in 10% formic acid, and processed for routine histological embedding. Sections (5 µm thick) were stained with hematoxylin and eosin for histomorphometric evaluation of newly formed bone, connective tissue, vascularization, and residual graft particles.

Immunohistochemical staining for bone morphogenetic protein-2 (BMP-2) was performed following antigen retrieval. BMP-2 expression was quantified using a semi-quantitative HSCORE method combining staining intensity (0-3) and the percentage of positively stained cells. Five randomly selected fields per section were evaluated at ×40 magnification independently by two blinded observers.

Statistical analyses were performed using IBM SPSS Statistics version 21. The normality of continuous variables was assessed using the Shapiro-Wilk test. Normally distributed variables were analyzed using one-way ANOVA followed by Bonferroni post hoc comparisons, whereas non-normally distributed variables were analyzed using the Kruskal-Wallis test followed by Bonferroni-corrected Mann-Whitney U tests for pairwise comparisons. A p-value ≤ 0.05 was considered statistically significant.

Being tested
Autogenous Dentin Graft, Platelet-Rich Fibrin (PRF), Freeze-Dried Bone Allograft (FDBA)
Keywords
Alveolar ridge preservation, Autogenous dentin graft, Platelet-rich fibrin, Extraction socket, Bone regeneration, BMP-2
Medical subject headings
Alveolar Bone Loss

What participants receive

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

  • Autogenous Dentin GraftBiological

    Particulate graft material (300-1200 µm) obtained by processing the patient's own extracted tooth using the Smart Dentin Grinder device (KometaBio, Israel), placed into the extraction socket.

  • Platelet-Rich Fibrin (PRF)Biological

    Autogenous dentin particles combined with platelet-rich fibrin, prepared by centrifugation of the patient's own venous blood (2700-3000 rpm, 10-12 minutes), placed into the extraction socket.

  • Freeze-Dried Bone Allograft (FDBA)Biological

    Commercial freeze-dried bone allograft placed into the extraction socket as a comparator graft material.

Study groups in NCT07789262
Study groupRoleWhat they receive
ControlNo interventionExtraction sockets were left to heal spontaneously without any graft material, based on natural blood clot formation, with no flap surgery performed.
DentinExperimentalExtraction sockets were grafted with autogenous dentin particles obtained from the patient's own extracted tooth, processed using the Smart Dentin Grinder device.
Receives: Biological: Autogenous Dentin Graft
Dentin + PRFExperimentalExtraction sockets were grafted with autogenous dentin particles combined with platelet-rich fibrin (PRF) prepared from the patient's own venous blood.
Receives: Biological: Autogenous Dentin Graft; Biological: Platelet-Rich Fibrin (PRF)
FDBAActive comparatorExtraction sockets were grafted with a commercial freeze-dried bone allograft (FDBA), used as a standard comparator graft material.
Receives: Biological: Freeze-Dried Bone Allograft (FDBA)

What is being measured

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

  1. Percentage of Newly Formed Bone

    Histomorphometric quantification of the percentage of newly formed bone within the grafted extraction socket, assessed on hematoxylin and eosin-stained sections of bone core biopsies obtained at the time of implant placement.

    Measured: 4 months after grafting

  2. Percentage of Connective Tissue Formation

    Histomorphometric quantification of the percentage of connective tissue within the bone core biopsy specimens.

    Measured: 4 months after grafting

  3. Vascularization

    Histomorphometric assessment of new vessel formation within the bone core biopsy specimens.

    Measured: 4 months after grafting

  4. BMP-2 Immunoexpression (HSCORE)

    Semi-quantitative immunohistochemical assessment of bone morphogenetic protein-2 (BMP-2) expression, calculated using the HSCORE method combining staining intensity and percentage of positive cells.

    Measured: 4 months after grafting

Timeline

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

  1. First posted27 Aug 2026
  2. Study start15 Dec 2023
  3. Primary completion15 Apr 2024
  4. Study completion8 Dec 2025

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 56 extraction sockets were randomly allocated in parallel to one of four independent treatment groups: spontaneous healing (Control), autogenous dentin graft alone (Dentin), autogenous dentin graft combined with platelet-rich fibrin (Dentin + PRF), or freeze-dried bone allograft (FDBA). Each socket received only one treatment throughout the study, with outcomes compared across groups at a single follow-up timepoint four months after grafting, corresponding to the time of dental implant placement.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07789262
Sponsor's protocol ID
TDH-2024-2429
Other IDs
Ethics Committee
Acronym
ARF-PRF
Status last verified
Aug 2026
First submitted
22 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared, as this was not specified in the study protocol approved by the institutional ethics committee, and participant consent did not include provisions for external data sharing.

Questions about this trial

What is this clinical trial studying?

A study testing Autogenous Dentin Graft, Platelet-Rich Fibrin (PRF) and Freeze-Dried Bone Allograft (FDBA) in people with Tooth Extraction and Alveolar Bone Loss, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Newly Formed Bone (time frame: 4 months after grafting). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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