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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.
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):
2.3. Secondary Endpoints
Post-operative changes in probing pocket depth (PPD):
Post-operative changes in papilla height (preservation of soft tissues):
Post-operative changes in intra-bony defect morphology:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss® collagen + Emdogain® | Placebo Comparator | minimally invasive surgery + Bio-Oss® collagen + Emdogain® (MIS + BO + Enamel Matrix Derivative) |
|
| Bio-Oss® collagen + REGENFAST® | Active Comparator | minimally invasive surgery + Bio-Oss® collagen + REGENFAST® (MIS + BO + hyaluronic acid) |
|
| Bio-Oss® collagen + L-PRF | Active Comparator | minimally invasive surgery + Bio-Oss® collagen + L-PRF (MIS + BO + Leucocyte -Platelet Rich Fibrin) |
|
| L-PRF | Active Comparator | minimally invasive surgery + L-PRF (MIS + Leucocyte-Platelet Rich Fibrin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgical treatment of the intra-bony defects | Biological | A surgical procedure is performed under local anaesthesia in which one of the biomaterials will be used to fill the intra-bony defect. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative changes in clinical attachment level (CAL) | difference between the baseline and 6/12 months after the surgery measured in mm | 6/12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative changes in probing pocket depth (PPD) | difference between the baseline and 6/12 months after the surgery measured in mm | 6/12 months after the surgery |
| Post-operative changes in papilla height (preservation of soft tissues) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana B Castro Sarda, Professor | Contact | +32 16 332816 | ana.castro@uzleuven.be | |
| Lieve Desmet, secretary | Contact | +32 16 332407 | lieve.desmet@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Ana Castro, Professor | UZLeuven, department of Oral Health Sciences, Periodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZLeuven, Campus St. Raphaël, Department Oral Health Sciences, Periodontology | Recruiting | Leuven | Vlaams Brabant | 3000 | Belgium |
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| Use of the xenograft Bio-Oss® Collagen during the surgery | Biological | 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®) | Biological | 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®) | Biological | 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) | Biological | The clinician will use L-PRF as adjuvant in the surgical treatment of the intra-bony defects in conjunction with minimally invasive surgery. |
|
difference between the baseline and 6/12 months after the surgery measured by means of a volumetric analysis based on intra-oral scan
| 6/12 months after the surgery |
| Post-operative changes in intra-bony defect morphology | difference between the baseline and 6/12 months after the surgery, via periapical radiograph (parallel angle technique); defect resolution measured in millimetres and bone fill measured in percentage | 6/12 months after the surgery |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C109069 | enamel matrix proteins |
| D007958 | Leukocyte Count |
| ID | Term |
|---|---|
| D001772 | Blood Cell Count |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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