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Biologicals in Management of Intra-Bony Defects

RecruitingNAAges 18 Years - anyAllUniversitaire Ziekenhuizen KU Leuven
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Minimally invasive surgical treatment of the intra-bony defects
  • Use of the xenograft Bio-Oss® Collagen during the surgery
  • Use of enamel matrix derivative (Emdogain®)
  • Use of hyaluronic acid (REGENFAST®)
  • use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)
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Where

1 site
UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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