Actively Recruiting
Biologicals in Management of Intra-Bony Defects
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-03-17
30
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Biologicals in Management of Intra-Bony Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent obtained prior to screening
- At least 18 years old at signing the informed consent form
- American Society of Anesthesiology (ASA) score I or II
- Completed non-surgical periodontal therapy with remaining local pockets of 6 mm or more
- Intra-bony defect is non-contained (2-wall defect)
- Clinical indication for minimally invasive surgical treatment of intra-bony defects with biologicals
You will not qualify if you...
- Under 18 years old
- Any disorder that might risk participant safety or protocol compliance
- Prior or current treatments jeopardizing safety or study integrity
- Participation in another interventional trial with investigational product or device
- Known or suspected current malignancy
- History of chemotherapy
- History of radiation in the head and neck area
- History of other metabolic bone diseases
- Current or previous use of intravenous or oral bisphosphonates
- Blood disorders
- Pregnancy or lactation
- Smoking
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
Leuven, Vlaams Brabant, Belgium, 3000
Actively Recruiting
Research Team
A
Ana B Castro Sarda, Professor
CONTACT
L
Lieve Desmet, secretary
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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