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Not feasible to recruit and follow-up subjects due to the pandemic
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Teeth with furcation grade III defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade III defects with open flap debridement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open flap debridement with osteoplasty | Experimental | In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area. |
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| Open flap debridement without osteoplasty | Active Comparator | In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open flap debridement with osteoplasty | Procedure | Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to >90 degrees relative to the apico-coronal axis of the tooth. |
| Measure | Description | Time Frame |
|---|---|---|
| Sites with no signs of inflammation | Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment | 12 months after treatment |
| Sites with no signs of inflammation | Proportion of sites without inflammation, defined as no BoP or PPD>4mm following treatment | 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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Dentistry, University of Oslo, Norway | Oslo | Norway |
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| ID | Term |
|---|---|
| D017823 | Furcation Defects |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| Open flap debridement without osteoplasty | Procedure | Treatment of furcation grade III defect with open flap debridement only. |
|
| 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 |
| Loss of clinical attachment level | To assess further loss of clinical attachment level by the use of a periodontal probe | 12 months after treatment |
| Loss of clinical attachment level | To assess further loss of clinical attachment level by the use of a periodontal probe | 24 months after treatment |
| Number of participants with caries lesions | To assess caries lesions in furcation defects following therapy. Caries lesions are assessed clinically with an explorer as caries (Y/N) | 24 months after treatment |
| Radiographic changes | To assess bone loss as measured on standardized radiographs (in mm) | 12 months after treatment |
| Radiographic changes | To assess bone loss as measured on standardized radiographs (in mm) | 24 months after treatment |