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Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial

RecruitingNAAges 18 Years - 80 YearsAllUniversity of Belgrade
NCT07671963 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This multicenter randomized controlled clinical trial aims to compare the clinical, radiographic, microbiological and molecular outcomes of two collagenated xenogeneic bone substitutes (GTO® and GenOs®) used in combination with the Non-Incised Papilla Surgical Approach (NIPSA) for the treatment of intrabony periodontal defects. The study will evaluate whether differences exist between the two biomaterials with respect to clinical attachment gain, defect resolution, wound healing and biological markers of regeneration.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of Stage III periodontitis * At least one intrabony periodontal defect with probing depth \> 5 mm following completion of non-surgical periodontal therapy * Full-mouth plaque score (FMPS) \< 20% * Full-mouth bleeding score (FMBS) \< 20% * Ability to understand the study procedures and provide written informed consent Exclusion Criteria: * Systemic medical contraindications to periodontal surgery * History of head and neck radiotherapy * Poor oral hygiene or lack of motivation/compliance * Uncontrolled diabetes mellitus * Pregnancy or lactation * Treatment with antiresorptive medications or other drugs affecting bone remodeling * Heavy smoking (\>20 cigarettes/day)
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What it tests

  • GTO® with NIPSA surgical approach
  • GenOs® + NIPSA
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Where

2 sites
Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy
Cagliari, Italy
Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade
Belgrade, Serbia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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