Biologicals in Management of Intra-Bony Defects
NCT07292870 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-17
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.
Conditions
- Intra-bony Pockets
- Periodontitis
Interventions
- 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.
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Principal Investigators
-
Ana Castro, Professor · UZLeuven, department of Oral Health Sciences, Periodontology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-08-08
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Belgium
Study Locations
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