Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial
Recruiting now · Not applicable
Conditions studied: Periodontitis (Stage 3), Minimally Invasive Surgical Procedures, Bone Substitutes
In brief
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.
Key facts
- Study ID
- NCT07671963
- Run by
- University of Belgrade
- People needed
- 30
- Starts
- 2026-07-01
- Expected to finish
- 2027-03-01
- Last updated by the study team
- 2026-06-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy — Cagliari, Italy, Italy (enrolling)
- Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade — Belgrade, Serbia (enrolling)
Full record on ClinicalTrials.gov
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