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.

Enrolling by invitation · Not applicable

Conditions studied: Periodontitis

In brief

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.

Key facts

Study ID

NCT06991998

Run by

Semmelweis University

People needed

60

Starts

2024-10-24

Expected to finish

2026-10-24

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with chronic periodontitis
• Both male and female participants
• Patients with less than 25% plaque score (FMPS: Full Mouth Plaque Score) and bleeding index (FMBS: Full Mouth Bleeding Score) after non-surgical periodontal therapy
• Good patient compliance (maintains good oral hygiene and is willing to participate in 12-month follow-up)
• Patients who understand the nature of the study after receiving written information and provide signed informed consent
• Patients older than 18 years
• Non-self-contained intraosseous defects (wide (radiological angle > 37°) and/or one- or two-wall defects) in the maxilla or mandible with a baseline probing depth of ≥ 6 mm
• The defect has an intraosseous component of ≥ 3 mm
• The patient has at least one tooth that needs extraction for any reason

You may not qualify if…

• Patients with systemic conditions such as:
• Alcoholism Drug addiction Known HIV, HBV, or HCV infection Patients undergoing chemotherapy or radiation therapy Current or past head and neck radiation therapy Untreated insulin-dependent diabetes mellitus Clinically significant osteoporosis or other systemic conditions affecting bone metabolism Clinically significant cardiovascular conditions such as decompensated heart failure, hemodynamically significant heart valve insufficiency, or myocardial infarction within the last 3 months Clinically significant coagulation disorders
• Previous or current systemic corticosteroid therapy (within 2 months of inclusion): more than 5 mg of prednisolone per day
• Previous or current bisphosphonate therapy lasting at least 30 days within the past 12 months
• Long-term antibiotic or anti-inflammatory therapy within the past 4 months
• Pregnant or breastfeeding women
• Smoking (>5 cigarettes/day)
• Furcation involvement
• Wisdom teeth

Where it is running

• Semmelweis University, Department of Periodontology — Budapest, Budapest, Hungary

Full record on ClinicalTrials.gov

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