Health Trials

About this trial

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 criteria

Qualifiers

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%

Disqualifiers

Systemic medical contraindications to periodontal surgery

History of head and neck radiotherapy

Poor oral hygiene or lack of motivation/compliance

Uncontrolled diabetes mellitus

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

2
Italy
Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy CagliariItaly, Italy
Serbia
Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade Belgrade Serbia

Sponsors and collaborators

University of Belgrade

Lead sponsor

Cittadella Universitaria

Collaborator

Source ClinicalTrials.gov