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Teeth with furcation grade III defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regenerative therapy w/BCP and collagen membrane | Experimental | In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane. |
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| Regenerative therapy w/BCP and enamel matrix proteins | Active Comparator | In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) | Device | Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of furcation grade level | Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe | 12 months after treatment |
| Change of furcation grade level | Proportion of sites demonstrating improvement in furcation grade level as measured with Nabers probe | 24 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in patient-reported quality of life (QoL) | To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1). |
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Inclusion Criteria:
Exclusion Criteria:
The following must not be present at the time of enrolment;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo | Oslo | 0455 | Norway |
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| Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) | Drug | Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins. |
|
| Preoperatively compared to 24 months after treatment |
| Changes in patient-reported quality of life (QoL) | To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected, (2) less than once a month, (3) once or twice a month, (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome. Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected, including category (1). | Preoperatively compared to 12 months after treatment |
| Changes in defect morphology assessed by CBCT | Cone beam computed tomography will be acquired at baseline, 2 weeks postoperatively and 24 months postoperatively. This outcome measures quantitative morphologic changes in the furcation defects at 24 months | 24 months after treatment |
| Changes in pocket probing depth | Changes in pocket probing depth will be measured with a probe | 12 months after treatment |
| Changes in pocket probing depth | Changes in pocket probing depth will be measured with a probe | 24 months after treatment |
| Changes in PPD | Changes in pocket probing depth will be measured with a probe | 12 months after treatment |
| Changes in PPD | Changes in pocket probing depth will be measured with a probe | 24 months after treatment |
| Radiographic changes | Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs | 12 months after treatment |
| Radiographic changes | Standardized intraoral bitewing radiographs will be obtained and compared to baseline radiographs | 24 months after treatment |
| Pain following surgery | Pain sensation one week posteoperatively will be recorded on a visual analog scale from 0-10. 0 means no pain sensation, whereas 10 means highest pain imagineable. | Up to 1 week postoperatively |
| Caries assessment | Caries in furcation defect assessed with an explorer will be recorded as (Y/N) | 24 months |
| Caries assessment | Caries in furcation defect assessed with an explorer will be recorded as (Y/N) | 12 months |
| ID | Term |
|---|---|
| D017823 | Furcation Defects |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C074950 | hydroxyapatite-beta tricalcium phosphate |
| C109069 | enamel matrix proteins |
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