Biologicals in Management of Intra-Bony Defects
Evaluation of the Addition of Different Biologicals in the Surgical Treatment of Periodontal Intra-Bony Defects: A Randomised Controlled Clinical Trial.
Universitaire Ziekenhuizen KU Leuven
30 participants
Aug 8, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria12
- 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
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Interventions
A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.
The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
The clinician will use Enamel matrix derivative (Emdogain®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.
The clinician will use hyaluronic acid (REGENFAST®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07292870