Biologicals in Management of Intra-Bony Defects (NCT07292870) | Clinical Trial Compass
RecruitingNot Applicable
Biologicals in Management of Intra-Bony Defects
Belgium30 participantsStarted 2025-08-08
Plain-language summary
The aim is of this study is to evaluate and compare the effects (clinical and radiological) of different biomaterials on the repair of bone defects around the teeth. When participating in this study, persons will be scheduled for local surgical intervention of the gums. Under local anaesthesia, the gums will be opened minimally to gain insight into the underlying bone defect. After the bone defect has been made completely free of inflammation, they will be randomly assigned to one of the groups below and the biomaterials for this group will be used to fill the defect around your teeth. The different biomaterials are artificial bone + amelogenin; artificial bone + hyaluronic acid; artificial bone + blood preparation (L-PRF) or blood preparation alone.
Then the gums will be closed again with a suture and they will receive the necessary instructions regarding the procedure.
Who can participate
Age range
18 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:
* Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
* At least 18 years of age at the time of signing the Informed Consent Form (ICF)
* American Society of Anesthesiology (ASA) score I or II
* Has already completed the non-surgical periodontal therapy with remaining local pockets of ≥ 6 mm14
* The intra-bony defect should be non-contained (2-wall defect)
* Clinical indication for surgical treatment of the intra-bony defect with minimally invasive approach in conjunction with biologicals
Exclusion Criteria:
* Under the age of 18 years
* Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
* Participation in an interventional Trial with an investigational medicinal product (IMP) or device
* Known or suspected current malignancy
* History of chemotherapy
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* Current or previous use of intravenous and oral bisphosphonates
* Haematological disorders
* Pregnancy / lactation
* Smoking
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.
What they're measuring
1
Post-operative changes in clinical attachment level (CAL)