NCT07292870

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Intra-bony Pockets
• Periodontitis

Interventions

Type	Name	Description
BIOLOGICAL	Minimally invasive surgical treatment of the intra-bony defects	A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect.
BIOLOGICAL	Use of the xenograft Bio-Oss® Collagen during the surgery	The clinician will use Bio-Oss® Collagen as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
BIOLOGICAL	Use of enamel matrix derivative (Emdogain®)	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.
BIOLOGICAL	Use of hyaluronic acid (REGENFAST®)	The clinician will use hyaluronic acid (REGENFAST®) as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery
BIOLOGICAL	use of the blood derivative L-PRF (leukocyte and platelet rich fibrin)	The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery.

Timeline

• Start date: 2025-08-08
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-12-18
• Last updated: 2026-03-17

Locations

1 site across 1 country: Belgium