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.

NCT06991998 | Enrolling By Invitation

• 1 other identifier: 200/2024.
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

periodontal regeneration; periodontitis; graft; intrabony defect; tooth-derived graft; enamel matrix derivatives; autogenous bone graft

Outcome Measures

Primary Outcomes (1)

• Probing pocket depth (PPD)

  At baseline and at 6 months and 12 months following the surgical intervention

Secondary Outcomes (5)

• Bone fill in the intraosseous defects

  During the surgical intervention and after 12 months during the re-entry

• Postoperative pain level

  7 days from the surgical intervention

• Clinical attachment gain (∆CAL)

  At baseline and at 6 months and 12 months following the surgical intervention

• Changes in gingival recession (∆GR)

  At baseline and at 6 months and 12 months following the surgical intervention

• Radiological bone fill

  At baseline and at 6 months and 12 months following the surgical intervention

Study Arms (2)

Autogenous Bone Graft + EMD

ACTIVE COMPARATOR

Procedure: Autogenous bone graft with enamel matrix derivative

Autogenous Tooth-Derived Graft + EMD

EXPERIMENTAL

Procedure: Autogenous tooth-derived graft with enamel matrix derivative

Interventions

Autogenous tooth-derived graft with enamel matrix derivative PROCEDURE

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.

Autogenous Tooth-Derived Graft + EMD

Autogenous bone graft with enamel matrix derivative PROCEDURE

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.

Autogenous Bone Graft + EMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Department of Periodontology

Budapest, Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Periodontist

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: May 28, 2025
• Study Start: October 24, 2024
• Primary Completion (Estimated): October 24, 2026
• Study Completion (Estimated): October 24, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

HU (1)