Evaluation of Clinical and Radiological Outcomes Following the Treatment of Periodontal Intraosseous Defects Using Autogenous Tooth-derived Graft or Autogenous Bone Graft With Enamel Matrix Derivatives. A 12-month Randomized Controlled Clinical Trial.

Summary

This clinical study aims to evaluate and compare two different materials used to treat bone defects caused by periodontitis. Periodontitis is a chronic inflammatory condition that damages the supporting structures of teeth, including the bone. One of the most severe forms of this damage is called an "intraosseous defect," where the bone around a tooth is lost in a vertical pattern.

To repair these defects, dentists often perform a regenerative surgery using grafting materials and biologically active substances to stimulate tissue regrowth. The current standard includes using autogenous bone grafts (ABG)-bone taken from another part of the patient's mouth-combined with enamel matrix derivatives (EMD), a protein-based gel that promotes healing. However, this approach requires creating a second surgical site to harvest the bone, which can increase patient discomfort and healing time.

Recently, a promising alternative has emerged: autogenous tooth-derived bone grafts (ATB). In this technique, a patient's own extracted tooth is processed into a grafting material and used to fill the bone defect. This method has the advantage of using a material that would otherwise be discarded and avoids the need for an additional surgical area. Early studies suggest that tooth-derived grafts may have similar regenerative potential to traditional bone grafts because of their comparable structure and the presence of natural growth factors.

The purpose of this randomized controlled trial is to determine whether ATB combined with EMD can achieve the same or better clinical and radiological outcomes as ABG combined with EMD in the treatment of periodontal intraosseous defects.

A total of 60 adult patients with chronic periodontitis will be enrolled. Each participant must have at least one advanced bone defect around a tooth and one other tooth that needs to be extracted for unrelated reasons. Patients will be randomly assigned to receive either ATB or ABG, both with EMD, during a single surgical procedure.

The study includes multiple follow-up visits over the course of one year, and at 12 months, a re-entry surgery will allow the research team to directly observe bone healing inside the defect.

The findings could support a more patient-friendly and equally effective alternative to traditional bone grafting in periodontal regenerative surgery.

Conditions

• Periodontitis

Interventions

PROCEDURE

Autogenous bone graft with enamel matrix derivative

Participants receive periodontal regenerative surgery using autogenous bone graft harvested from a secondary intraoral donor site (mandibular ramus or maxillary tuberosity) with a bone scraper. The bone graft is placed into the debrided intraosseous defect, and enamel matrix derivative (EMD) is applied to the root surface. Surgical access is performed using a single flap approach (SFA), and primary closure is achieved with microsurgical sutures.

PROCEDURE

Autogenous tooth-derived graft with enamel matrix derivative

Participants receive periodontal regenerative surgery using autogenous tooth-derived particulate graft processed from an extracted tooth using a standardized protocol (Bonmaker® device and chemical decontamination), combined with enamel matrix derivative (EMD) applied to the root surface. The surgical site is accessed using a single flap approach (SFA), and graft material is placed into the non-self-contained intraosseous defect after debridement. Primary closure is achieved with microsurgical sutures.

Sponsors & Collaborators

• Semmelweis University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-24

Primary Completion

2026-10-24

Completion

2026-10-24

Countries

• Hungary

Study Locations