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

Conditions: Periodontitis (Stage 3), Minimally Invasive Surgical Procedures, Bone Substitutes

Sex: All

Ages: 18 Years – 80 Years

Healthy volunteers: Yes

Phase: NA

Enrollment: 30

Sponsor: University of Belgrade

Location: Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy Cagliari Italy

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 Criteria

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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07671963). StuddyBuddy aggregates publicly available trial information.