Periodontal Disease
Conditions
Keywords
Regenerative therapy, Randomized clinical trial (RCT), Enamel matrix derivative, Hydroxyapatite-beta tricalcium phosphate, Buccal furcation
Brief summary
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).
Detailed description
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.
Interventions
DRUGEMD
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).
DEVICEβTCP/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)
PROCEDUREFlap 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.
Sponsors
University of Campinas, Brazil
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, between 18-75 years of age; * Presence of a mandibular molar with buccal class-II furcation defect, presenting PD ≥ 4mm, bleeding on probing (BOP), minimum (\<1 mm) or no gingival recession after non-surgical therapy; * Good general health; * Minimum interproximal bone loss (\< 2 mm).
Exclusion criteria
* Pregnant or lactating; * Required antibiotic pre-medication for the performance of periodontal examination and treatment; * Suffered from any other systemic diseases (cardiovascular, pulmonary, liver, cerebral, diseases or diabetes); * Had received antibiotic treatment in the previous 3 months; * Were taking long-term anti-inflammatory drugs; * Had received a course of periodontal treatment within the last 6 months; * Smokers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | 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. |
| Periodontal Probing Depth at 12 Months | 12 months | — |
| Relative Gingival Margin Position (RGMP) at 12 Months | 12 months | — |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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). | 14 |
| 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. | 13 |
| Total | 41 |
Baseline characteristics
| Characteristic | βTCP/HA Alone | EMD + βTCP/HA | EMD Alone | Total |
|---|---|---|---|---|
| Age, Customized <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 18 and 65 years | 14 Participants | 14 Participants | 13 Participants | 41 Participants |
| Age, Customized | 53.69 Years STANDARD_DEVIATION 6.58 | 53.14 Years STANDARD_DEVIATION 5.92 | 54.57 Years STANDARD_DEVIATION 5.63 | 53.80 Years STANDARD_DEVIATION 5.92 |
| Bleeding on probing (BOP) | 9.67 Percent of surfaces with bleeding STANDARD_DEVIATION 3.1 | 9.68 Percent of surfaces with bleeding STANDARD_DEVIATION 2.76 | 8.69 Percent of surfaces with bleeding STANDARD_DEVIATION 1.84 | 9.36 Percent of surfaces with bleeding STANDARD_DEVIATION 2.61 |
| Plaque index (PI) | 14.57 Percent of surfaces with plaque STANDARD_DEVIATION 3.83 | 14.36 Percent of surfaces with plaque STANDARD_DEVIATION 3.1 | 13.54 Percent of surfaces with plaque STANDARD_DEVIATION 2.99 | 14.17 Percent of surfaces with plaque STANDARD_DEVIATION 3.28 |
| Probing depth (PD) | 4.92 mm STANDARD_DEVIATION 0.49 | 4.93 mm STANDARD_DEVIATION 0.73 | 4.79 mm STANDARD_DEVIATION 0.7 | 4.87 mm STANDARD_DEVIATION 0.64 |
| Relative gingival margin position (RGMP) | 10.15 mm STANDARD_DEVIATION 0.9 | 9.57 mm STANDARD_DEVIATION 1.09 | 9.43 mm STANDARD_DEVIATION 1.34 | 9.60 mm STANDARD_DEVIATION 1.09 |
| Relative horizontal clinical attachment level (RHCAL) | 5.08 mm STANDARD_DEVIATION 0.49 | 5.64 mm STANDARD_DEVIATION 0.93 | 5.5 mm STANDARD_DEVIATION 0.76 | 5.41 mm STANDARD_DEVIATION 0.77 |
| Relative vertical clinical attachment level (RVCAL) | 14.38 mm STANDARD_DEVIATION 1.76 | 14.64 mm STANDARD_DEVIATION 1.22 | 14.07 mm STANDARD_DEVIATION 1.44 | 14.36 mm STANDARD_DEVIATION 1.46 |
| Sex/Gender, Customized Female | 9 Participants | 10 Participants | 8 Participants | 27 Participants |
| Sex/Gender, Customized Male | 5 Participants | 4 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| βTCP/HA Alone | Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | 2.31 mm | Standard Deviation 0.75 |
| EMD + βTCP/HA | Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | 3.00 mm | Standard Deviation 1.04 |
| EMD Alone | Relative Horizontal Clinical Attachment Level (RHCAL) at 12 Months | 2.57 mm | Standard Deviation 0.94 |
Secondary
Periodontal Probing Depth at 12 Months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| βTCP/HA Alone | Periodontal Probing Depth at 12 Months | 2.38 mm | Standard Deviation 0.65 |
| EMD + βTCP/HA | Periodontal Probing Depth at 12 Months | 2.57 mm | Standard Deviation 0.76 |
| EMD Alone | Periodontal Probing Depth at 12 Months | 2.36 mm | Standard Deviation 1.08 |
Secondary
Relative Gingival Margin Position (RGMP) at 12 Months
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| βTCP/HA Alone | Relative Gingival Margin Position (RGMP) at 12 Months | 9.92 mm | Standard Deviation 1.12 |
| EMD + βTCP/HA | Relative Gingival Margin Position (RGMP) at 12 Months | 9.79 mm | Standard Deviation 1.12 |
| EMD Alone | Relative Gingival Margin Position (RGMP) at 12 Months | 9.57 mm | Standard Deviation 1.02 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| βTCP/HA Alone | Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | 12.31 mm | Standard Deviation 1.38 |
| EMD + βTCP/HA | Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | 12.36 mm | Standard Deviation 1.5 |
| EMD Alone | Relative Vertical Clinical Attachment Level (RVCAL) at 12 Months | 11.93 mm | Standard Deviation 1.27 |