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Clinical Trials in Italy / NCT07671963
Recruiting Not applicable

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

NCT07671963 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Belgrade
Phase
Not applicable
Started
2026-07-01
Last updated
2026-06-26

Condition(s) studied

Periodontitis (Stage 3)Minimally Invasive Surgical ProceduresBone Substitutes

Investigational drug(s) / intervention(s)

GTO® with NIPSA surgical approachGenOs® + NIPSA

GTO® with NIPSA surgical approach: Regenerative periodontal surgical treatment using the Non-Incised Papilla Surgical Approach (NIPSA) combined with GTO® collagenated xenogeneic bone substitute for the treatment of intrabony periodontal defects.

GenOs® + NIPSA: Regenerative periodontal surgical treatment using the Non-Incised Papilla Surgical Approach (NIPSA) combined with GenOs® collagenated xenogeneic bone substitute for the treatment of intrabony periodontal defects.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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)

Primary outcome measure(s)

  • Clinical Attachment Level (CAL) gain — Baseline to 6 months
    Change in clinical attachment level (CAL) at treated intrabony periodontal defects from baseline to 6 months following regenerative periodontal therapy using either GTO® or GenOs® in combination with the Non-Incised Papilla Surgical Approach (NIPSA).

Trial sites (2)

FacilityCityRegionStatus
Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy Cagliari Italy Recruiting
Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade Belgrade Serbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07671963 on ClinicalTrials.gov ↗ ← All trials in Italy