Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA).
To clinically evaluate the treatment of mandibular class II furcation defects with enamel matrix derivative (EMD) and/or a bone substitute graft make of beta tricalcium phosphate/hydroxyapatite (βTCP/HA). Forty-one patients, presenting a mandibular class II buccal furcation defect, probing pocket depth (PPD) ≥ 4 mm and bleeding on probing, will be included. They will be randomly assigned to the groups: 1- EMD (n = 13); 2- βTCP/HA (n = 14); 3- EMD + βTCP/HA (n = 14). Relative gingival margin position (RGMP), relative vertical and horizontal attachment level (RVCAL and RHCAL) and PPD will be evaluated at baseline and 12 months. The mean horizontal clinical attachment level gain will be considered the primary outcome variable.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMD alone | Active Comparator | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. |
|
| βTCP/HA alone | Active Comparator | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) |
|
| EMD + βTCP/HA | Active Comparator | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMD | Drug | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland). |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enilson A Sallum, PhD | University of Campinas, Brazil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Piracicaba Dental School, State University of Campinas | Piracicaba | São Paulo | 13414-903 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EMD Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
| FG001 | βTCP/HA Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
| FG002 | EMD + βTCP/HA | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Potential patients were selected from those referred to the Graduate Clinic of the Piracicaba Dental School. All patients received a complete periodontal examination, including anamnesis, a full-mouth periodontal probing, and radiographic examination. One furcation defect per patient was chosen, using Nabers probe.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | βTCP/HA Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Potential patients were selected from those referred to the Graduate Clinic of the Piracicaba Dental School. All patients received a complete periodontal examination, including anamnesis, a full-mouth periodontal probing, and radiographic examination. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | The relative horizontal clinical attachment level (RHCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced horizontally into the furcation and the lower border of the stent. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm. | Posted | Mean | Standard Deviation | mm | 12 months |
|
Serious and Other (Not Including Serious) Adverse Events were not collected/assessed
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | βTCP/HA Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
Not provided
Not provided
This clinical trial did not show limitations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof.Dr. Enilson Antonio Sallum | Piracicaba Dental School - University of Campinas | +55 19 2106-5301 | easallum@fop.unicamp.br |
Not provided
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C109069 | enamel matrix proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| βTCP/HA | Device | During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland) |
|
|
| Flap access surgery | Procedure | In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
|
| 12 months |
| Periodontal Probing Depth at 12 Months | 12 months |
| Relative Gingival Margin Position (RGMP) at 12 Months | 12 months |
| BG001 | EMD + βTCP/HA | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA). |
| BG002 | EMD Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Customized | Mean | Standard Deviation | Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Plaque index (PI) | Mean | Standard Deviation | Percent of surfaces with plaque |
|
| Bleeding on probing (BOP) | Mean | Standard Deviation | Percent of surfaces with bleeding |
|
| Probing depth (PD) | Mean | Standard Deviation | mm |
|
| Relative gingival margin position (RGMP) | Mean | Standard Deviation | mm |
|
| Relative vertical clinical attachment level (RVCAL) | Mean | Standard Deviation | mm |
|
| Relative horizontal clinical attachment level (RHCAL) | Mean | Standard Deviation | mm |
|
| OG001 | βTCP/HA + EMD | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
| OG002 | EMD Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. |
|
|
| Secondary | Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | The relative vertical clinical attachment level (RVCAL) will be measured with the same type of probe (PCP-15 Periodontal Probe - Hu-Friedy - Chicago, IL, USA) as the distance between the deepest point reached by the probe when introduced vertically into the buccal periodontal pocket. This parameter will be evaluated at one specific site at the buccal furcation entrance, determined by a groove made on an individually manufactured acrylic stent and recorded to the nearest 0.5mm. | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| Secondary | Periodontal Probing Depth at 12 Months | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| Secondary | Relative Gingival Margin Position (RGMP) at 12 Months | Posted | Mean | Standard Deviation | mm | 12 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | βTCP/HA + EMD | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. | 0 | 0 | 0 | 0 |
| EG002 | EMD Alone | During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned. EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland). Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. | 0 | 0 | 0 | 0 |
Not provided
Not provided