Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Belgrade
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 groupsSponsors and collaborators
University of Belgrade
Lead sponsor
Cittadella Universitaria
Collaborator
Source ClinicalTrials.gov