Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-08-08
2027-12-31
Brief Summary
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Then the gums will be closed again with a suture and they will receive the necessary instructions regarding the procedure.
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bio-Oss® collagen + L-PRF
minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin)
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.
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
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.
L-PRF
minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin)
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.
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.
Bio-Oss® collagen + Emdogain®
minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative)
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.
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
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.
Bio-Oss® collagen + REGENFAST®
minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid)
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.
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
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
Interventions
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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.
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
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.
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Ana Castro, Professor
Role: PRINCIPAL_INVESTIGATOR
UZLeuven, department of Oral Health Sciences, Periodontology
Locations
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UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology
Leuven, Vlaams Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Lieve Desmet, secretary
Role: primary
Ana Castro, Professor
Role: backup
Other Identifiers
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S69198
Identifier Type: -
Identifier Source: org_study_id