NCT07789262

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

August 1, 2026

Enrollment Period

4 months

First QC Date

August 22, 2026

Last Update Submit

August 25, 2026

Conditions

Keywords

Alveolar ridge preservationAutogenous dentin graftPlatelet-rich fibrinExtraction socketBone regenerationBMP-2

Outcome Measures

Primary Outcomes (4)

  • 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.

    4 months after grafting

  • Percentage of Connective Tissue Formation

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

    4 months after grafting

  • Vascularization

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

    4 months after grafting

  • 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.

    4 months after grafting

Study Arms (4)

Control

NO INTERVENTION

Extraction sockets were left to heal spontaneously without any graft material, based on natural blood clot formation, with no flap surgery performed.

Dentin

EXPERIMENTAL

Extraction sockets were grafted with autogenous dentin particles obtained from the patient's own extracted tooth, processed using the Smart Dentin Grinder device.

Biological: Autogenous Dentin Graft

Dentin + PRF

EXPERIMENTAL

Extraction sockets were grafted with autogenous dentin particles combined with platelet-rich fibrin (PRF) prepared from the patient's own venous blood.

Biological: Autogenous Dentin GraftBiological: Platelet-Rich Fibrin (PRF)

FDBA

ACTIVE COMPARATOR

Extraction sockets were grafted with a commercial freeze-dried bone allograft (FDBA), used as a standard comparator graft material.

Biological: Freeze-Dried Bone Allograft (FDBA)

Interventions

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.

DentinDentin + PRF

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.

Dentin + PRF

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

FDBA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazıt University, Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Histological and immunohistochemical evaluations, including HSCORE assessment of BMP-2 expression, were performed independently by two blinded observers who were unaware of the group allocation of each specimen. Surgical treatment allocation was not blinded to the operating surgeon or the patient, as the graft materials used (autogenous dentin, dentin combined with platelet-rich fibrin, freeze-dried bone allograft, or no graft) were visually and procedurally distinguishable.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

August 22, 2026

First Posted

August 27, 2026

Study Start

December 15, 2023

Primary Completion

April 15, 2024

Study Completion

December 8, 2025

Last Updated

August 27, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations