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Regenerative Therapy of Intrabony Periodontal Defects Using Bone Substitutes and a Minimally Invasive Nonincised Papilla Surgical Approach - A Randomized Controlled Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Italy
Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy
RECRUITING
Cagliari
Serbia
Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade
RECRUITING
Belgrade
Contact Information
Primary
Iva Z Milinkovic, DDS, PhD
iva.milinkovic@gmail.com
+381113629201
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 30
Treatments
Experimental: GTO® + NIPSA
Regenerative periodontal therapy using GTO® collagenated xenogeneic bone substitute in combination with the Non-Incised Papilla Surgical Approach (NIPSA).
Active_comparator: GenOs® + NIPSA
Regenerative periodontal therapy using GenOs® collagenated xenogeneic bone substitute in combination with the Non-Incised Papilla Surgical Approach (NIPSA).
Related Therapeutic Areas
Sponsors
Leads: University of Belgrade
Collaborators: Cittadella Universitaria

This content was sourced from clinicaltrials.gov