Using biological materials to repair bone defects around teeth
Evaluation of the Addition of Different Biologicals in the Surgical Treatment of Periodontal Intra-Bony Defects: A Randomised Controlled Clinical Trial.
NA · Universitaire Ziekenhuizen KU Leuven · NCT07292870
This study will test whether enamel matrix, hyaluronic acid, platelet‑rich fibrin, or a bone graft can help repair intra‑bony defects around teeth in adults with periodontitis who need minimally invasive gum surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Leuven, Vlaams Brabant) |
| Trial ID | NCT07292870 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with periodontitis who have completed non‑surgical therapy and have non‑contained (2‑wall) intra‑bony defects of ≥6 mm who are medically fit for minimally invasive periodontal surgery (ASA I–II) are ideal candidates.
Not a fit: People under 18, those with medical conditions that would jeopardize safety or protocol compliance, those with prior or concurrent treatments that compromise outcomes, or those without the specified 2‑wall defects are unlikely to benefit from enrollment.
Why it matters
Potential benefit: If successful, the alternatives could provide equally effective and potentially simpler or more accessible biological options to the current enamel matrix standard for repairing periodontal bone defects.
How similar studies have performed: Enamel matrix derivatives are an established treatment and smaller studies support benefits from platelet concentrates and hyaluronic acid, but direct head‑to‑head non‑inferiority comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven, Vlaams Brabant
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intra-bony Pockets, Periodontitis, Intra-bony defects, periodontitis, minimally invasive surgery, biologicals, L-PRF, Hyaluronic acid