Trial Outcomes & Findings for EMD and/or Bone Substitute for the Treatment of Class II Furcations (NCT NCT02474498)
NCT ID: NCT02474498
Last Updated: 2017-03-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
41 participants
Primary outcome timeframe
12 months
Results posted on
2017-03-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
14
|
|
Overall Study
COMPLETED
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EMD and/or Bone Substitute for the Treatment of Class II Furcations
Baseline characteristics by cohort
| Measure |
βTCP/HA Alone
n=14 Participants
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.
|
EMD + βTCP/HA
n=14 Participants
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).
|
EMD Alone
n=13 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Age, Customized
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Customized
|
53.69 Years
STANDARD_DEVIATION 6.58 • n=5 Participants
|
53.14 Years
STANDARD_DEVIATION 5.92 • n=7 Participants
|
54.57 Years
STANDARD_DEVIATION 5.63 • n=5 Participants
|
53.80 Years
STANDARD_DEVIATION 5.92 • n=4 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Plaque index (PI)
|
14.57 Percent of surfaces with plaque
STANDARD_DEVIATION 3.83 • n=5 Participants
|
14.36 Percent of surfaces with plaque
STANDARD_DEVIATION 3.1 • n=7 Participants
|
13.54 Percent of surfaces with plaque
STANDARD_DEVIATION 2.99 • n=5 Participants
|
14.17 Percent of surfaces with plaque
STANDARD_DEVIATION 3.28 • n=4 Participants
|
|
Bleeding on probing (BOP)
|
9.67 Percent of surfaces with bleeding
STANDARD_DEVIATION 3.1 • n=5 Participants
|
9.68 Percent of surfaces with bleeding
STANDARD_DEVIATION 2.76 • n=7 Participants
|
8.69 Percent of surfaces with bleeding
STANDARD_DEVIATION 1.84 • n=5 Participants
|
9.36 Percent of surfaces with bleeding
STANDARD_DEVIATION 2.61 • n=4 Participants
|
|
Probing depth (PD)
|
4.92 mm
STANDARD_DEVIATION 0.49 • n=5 Participants
|
4.93 mm
STANDARD_DEVIATION 0.73 • n=7 Participants
|
4.79 mm
STANDARD_DEVIATION 0.7 • n=5 Participants
|
4.87 mm
STANDARD_DEVIATION 0.64 • n=4 Participants
|
|
Relative gingival margin position (RGMP)
|
10.15 mm
STANDARD_DEVIATION 0.9 • n=5 Participants
|
9.57 mm
STANDARD_DEVIATION 1.09 • n=7 Participants
|
9.43 mm
STANDARD_DEVIATION 1.34 • n=5 Participants
|
9.60 mm
STANDARD_DEVIATION 1.09 • n=4 Participants
|
|
Relative vertical clinical attachment level (RVCAL)
|
14.38 mm
STANDARD_DEVIATION 1.76 • n=5 Participants
|
14.64 mm
STANDARD_DEVIATION 1.22 • n=7 Participants
|
14.07 mm
STANDARD_DEVIATION 1.44 • n=5 Participants
|
14.36 mm
STANDARD_DEVIATION 1.46 • n=4 Participants
|
|
Relative horizontal clinical attachment level (RHCAL)
|
5.08 mm
STANDARD_DEVIATION 0.49 • n=5 Participants
|
5.64 mm
STANDARD_DEVIATION 0.93 • n=7 Participants
|
5.5 mm
STANDARD_DEVIATION 0.76 • n=5 Participants
|
5.41 mm
STANDARD_DEVIATION 0.77 • n=4 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
βTCP/HA Alone
n=14 Participants
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.
|
βTCP/HA + EMD
n=14 Participants
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.
|
EMD Alone
n=13 Participants
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.
|
|---|---|---|---|
|
Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months
|
2.31 mm
Standard Deviation 0.75
|
3.00 mm
Standard Deviation 1.04
|
2.57 mm
Standard Deviation 0.94
|
SECONDARY outcome
Timeframe: 12 monthsThe 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.
Outcome measures
| Measure |
βTCP/HA Alone
n=14 Participants
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.
|
βTCP/HA + EMD
n=14 Participants
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.
|
EMD Alone
n=13 Participants
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.
|
|---|---|---|---|
|
Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months
|
12.31 mm
Standard Deviation 1.38
|
12.36 mm
Standard Deviation 1.5
|
11.93 mm
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
βTCP/HA Alone
n=13 Participants
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.
|
βTCP/HA + EMD
n=14 Participants
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.
|
EMD Alone
n=14 Participants
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.
|
|---|---|---|---|
|
Periodontal Probing Depth at 12 Months
|
2.38 mm
Standard Deviation 0.65
|
2.57 mm
Standard Deviation 0.76
|
2.36 mm
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
βTCP/HA Alone
n=13 Participants
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.
|
βTCP/HA + EMD
n=14 Participants
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.
|
EMD Alone
n=14 Participants
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.
|
|---|---|---|---|
|
Relative Gingival Margin Position (RGMP) at 12 Months
|
9.92 mm
Standard Deviation 1.12
|
9.79 mm
Standard Deviation 1.12
|
9.57 mm
Standard Deviation 1.02
|
Adverse Events
βTCP/HA Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
βTCP/HA + EMD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
EMD Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prof.Dr. Enilson Antonio Sallum
Piracicaba Dental School - University of Campinas
Phone: +55 19 2106-5301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place