Biologicals in Management of Intra-Bony Defects

The purpose of this study is to assess the clinical and radiological effectiveness of hyaluronic acid (REGENFAST®), enamel matrix derivative (Emdogain®), and platelet concentrates (L-PRF) in the surgical treatment (minimally invasive technique) of intra-bony defects in conjunction with minimally invasive surgery..

This is a non-inferiority study. The alternative hypothesis is that the use of hyaluronic acid or L-PRF obtained at least the same treatment outcome (seen as clinical attachment level gain) than the gold standard (use of enamel matrix derivatives).

2.2. Primary Endpoints

Post-operative changes in clinical attachment level (CAL):

• difference between the baseline and 6/12 months after the surgery
• measured in millimetres

2.3. Secondary Endpoints

Post-operative changes in probing pocket depth (PPD):

• difference between the baseline and 6/12 months after the surgery
• measured in millimetres

Post-operative changes in papilla height (preservation of soft tissues):

• difference between the baseline and 6/12 months after the surgery
• measured by means of a volumetric analysis based on intra-oral scan

Post-operative changes in intra-bony defect morphology:

• difference between the baseline and 6/12 months after the surgery
• periapical radiograph (parallel angle technique)
• defect resolution measured in millimetres
• bone fill measured in percentage

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