NCT07573761

Brief Summary

Tooth extraction triggers a cascade of biological events mediated by the local inflammatory response following surgical intervention and by the loss of masticatory stimulation to the periodontium. These factors disrupt the homeostasis and structural integrity of the periodontal tissues. Following tooth loss, bone remodeling is initiated and continues for several months, with the majority of dimensional and morphological changes occurring within the first three months. This early alveolar bone resorption may compromise future implant placement and prosthetic rehabilitation. Previous studies by Schmidt-Schultz and Schultz have demonstrated that biologically intact growth factors can be preserved within the collagenous extracellular matrix of ancient human bone and teeth. These findings suggest that stored dentin may retain biologically active growth factors and provide regenerative benefits comparable to those of freshly prepared dentin, while eliminating the need for simultaneous multiple surgical interventions. Moreover, the volume of particulate dentin exceeds twice the original root volume, allowing for the acquisition of sufficient graft material for clinical application. Based on these biological and volumetric advantages, the use of autogenous stored mineralized dentin grafts (ASMDG) has emerged as a promising approach for alveolar socket preservation. ASMDG may contribute to limiting post-extraction alveolar ridge resorption and maintaining ridge dimensions during the critical early healing period.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress45%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 2, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 7, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 20, 2026

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean change in horizontal alveolar ridge width (mm) from baseline to 4 months (CBCT)

    Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT) at baseline (immediately after tooth extraction) and at 4 months postoperatively prior to implant placement. The primary outcome will be defined as the mean change in ridge width (Δ width = width at 4 months - width at baseline), expressed in millimeters.

    Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)

Secondary Outcomes (1)

  • Mean change in vertical alveolar ridge height (mm) from baseline to 4 months (CBCT)

    Baseline (immediately after tooth extraction) and 4 months postoperatively (prior to implant placement)

Study Arms (2)

Study Group

Dentin graft socket preservation

Control Group

Spontaneous healing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult, systemically healthy patients indicated for the extraction of at least two posterior teeth with a hopeless prognosis due to periodontal disease, root caries, or root fractures, and who are candidates for implant-supported posterior rehabilitation. Eligible participants will present with intact alveolar socket walls after extraction, have no systemic or local contraindications affecting bone healing, and will provide written informed consent and comply with follow-up visits.

You may qualify if:

  • Patients requiring tooth extraction due to periodontal reasons (teeth with a hopeless prognosis), root caries, or root fractures, who are simultaneously candidates for posterior replacement with an osseointegrated implant, and who require extraction of at least two teeth.
  • Integrity of the alveolar socket walls following tooth extraction.
  • Patients who accept the study conditions, sign written informed consent, and agree to attend the scheduled follow-up visits.

You may not qualify if:

  • General contraindications for dental and/or surgical treatments.
  • Inflammatory or autoimmune diseases of the oral cavity.
  • Uncontrolled diabetes mellitus (HbA1c \> 7%).
  • History of malignancy requiring chemotherapy or radiotherapy within the past 5 years.
  • Previous treatment with immunosuppressive agents, bisphosphonates, or high-dose corticosteroids.
  • Smoking more than 10 cigarettes per day.
  • Pregnant or breastfeeding women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alveolar Bone LossPeriodontal DiseasesPeriodontal AtrophyBone DiseasesBone Resorption

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 20, 2026

First Posted

May 7, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-02

Locations