Status:
ENROLLING_BY_INVITATION
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.
Lead Sponsor:
Semmelweis University
Conditions:
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 supporti...
Detailed Description
This randomized controlled clinical trial investigates the regenerative efficacy of autogenous tooth-derived graft material (ATB) in comparison with autogenous bone graft (ABG) in the treatment of per...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06991998
Start Date
October 24 2024
End Date
October 24 2026
Last Update
May 28 2025
Active Locations (1)
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1
Semmelweis University, Department of Periodontology
Budapest, Budapest, Hungary, 1088