Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial (NCT07671963) | Clinical Trial Compass
RecruitingNot Applicable
Bone Substitutes and NIPSA in Intrabony Periodontal Defects: A Randomized Controlled Trial
Italy, Serbia30 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.