Using biological materials to repair bone defects around teeth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who meet entry criteria undergo minimally invasive surgical access to clean the intra‑bony defect and are then randomly assigned to receive one of four biomaterial approaches: xenograft (Bio‑Oss® Collagen) plus enamel matrix derivative (Emdogain®), xenograft plus hyaluronic acid (REGENFAST®), xenograft plus L‑PRF (leukocyte and platelet rich fibrin), or L‑PRF alone. The trial uses a non‑inferiority design to test whether hyaluronic acid or L‑PRF achieve at least the same clinical attachment level (CAL) gains as the enamel matrix derivative. Outcomes include changes in CAL and probing pocket depth (PPD) at 6 and 12 months, volumetric soft‑tissue (papilla) preservation by intra‑oral scan, and radiographic measures of defect resolution and bone fill. Procedures are performed at a single academic dental center with standard perioperative care and follow‑up visits at 6 and 12 months.

Why it matters

Who can join: the full rules

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

Where it's running

• UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
  Leuven, Vlaams Brabant, Belgium Recruiting

Study contacts

• Principal investigator: Ana Castro, Professor — UZLeuven, department of Oral Health Sciences, Periodontology
• Study coordinator: Ana B Castro Sarda, Professor
• Email: ana.castro@uzleuven.be
• Phone: +32 16 332816

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.