Bone substitutes with NIPSA for intrabony periodontal defects
Official title: Regenerative Therapy of Intrabony Periodontal Defects Using Bone Substitutes and a Minimally Invasive Nonincised Papilla Surgical Approach - A Randomized Controlled Clinical Trial
Run by University of Belgrade · NCT07671963 · Data updated 2026-11-12
This study tests two bone substitutes (GTO and GenOs) used with the NIPSA technique to see which supports better gum and bone healing in adults with Stage III periodontitis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Belgrade Academic / other |
| Locations | 2 sites (Cagliari, Italy and 1 other locations) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | February 1, 2027 |
| Study ends | March 1, 2027 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07671963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with Stage III periodontitis and at least one intrabony defect (>5 mm probing depth) after non-surgical therapy, and good oral hygiene.
✕Probably not a fit
Patients with uncontrolled systemic disease, poor oral hygiene, pregnancy, heavy smoking, radiotherapy history, or other exclusion criteria may not benefit from the intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized trial compares two collagenated xenogeneic bone substitutes, GTO and GenOs, both used with the Non-Incised Papilla Surgical Approach (NIPSA) for treating intrabony periodontal defects. Outcomes include clinical attachment gain, radiographic defect fill, wound healing, and biomarkers of regeneration. Participants are adults with Stage III periodontitis and at least one suitable intrabony defect after nonsurgical therapy. The study aims to determine if material composition and form influence regenerative results and tissue stability. Safety and feasibility are monitored across multiple centers.
Why it matters
Potential benefit: If successful, the trial could identify which biomaterial plus NIPSA offers better regeneration and healing for intrabony defects.
How similar studies have gone: Prior work suggests biomaterial choice can affect regenerative outcomes, but direct head‑to‑head comparisons with NIPSA are limited.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
Department of Periodontology, School of Dental Medicine, University of Cagliari Cittadella Universitaria di Monserrato Monserrato (CA), Italy
Cagliari, Italy, Italy Recruiting -
Department of Periodontology and Research Implant Center, School of Dental Medicine, University of Belgrade
Belgrade, Serbia Recruiting
Study contacts
- Principal investigator: Iva Z Milinkovic, DDS, PhD — School of Dental Medicine, University of Belgrade, Implant Research Centre and Department of Periodontology and Oral Medicine
- Study coordinator: Iva Z Milinkovic, DDS, PhD
- Email: iva.milinkovic@gmail.com
- Phone: +381113629201
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.