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Evaluation of the Addition of Different Biologicals in the Surgical Treatment of Periodontal Intra-Bony Defects: A Randomised Controlled Clinical Trial.

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• 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

Locations
Other Locations
Belgium
UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
RECRUITING
Leuven
Contact Information
Primary
Ana B Castro Sarda, Professor
ana.castro@uzleuven.be
+32 16 332816
Backup
Lieve Desmet, secretary
lieve.desmet@kuleuven.be
+32 16 332407
Time Frame
Start Date: 2025-08-08
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 30
Treatments
Placebo_comparator: Bio-Oss® collagen + Emdogain®
minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative)
Active_comparator: Bio-Oss® collagen + REGENFAST®
minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid)
Active_comparator: Bio-Oss® collagen + L-PRF
minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin)
Active_comparator: L-PRF
minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin)
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov