NCT07292870 Biologicals in Management of Intra-Bony Defects
| NCT ID | NCT07292870 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Intra-bony Pockets |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-08-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ana Castro, Professor
PRINCIPAL INVESTIGATOR
UZLeuven, department of Oral Health Sciences, Periodontology
Frequently Asked Questions
Who can join the NCT07292870 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intra-bony Pockets. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07292870 currently recruiting?
Yes, NCT07292870 is actively recruiting participants. Contact the research team at ana.castro@uzleuven.be for enrollment information.
Where is the NCT07292870 trial being conducted?
This trial is being conducted at Leuven, Belgium.
Who is sponsoring the NCT07292870 clinical trial?
NCT07292870 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Ana Castro, Professor at UZLeuven, department of Oral Health Sciences, Periodontology. The trial plans to enroll 30 participants.