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Due to change in strategy and decision not to expand indication.
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The primary objective of this study is to demonstrate that in supra-alveolar-type defects (i.e., defects displaying a predominately horizontal pattern of bone loss), periodontal surgery with the additional use of Straumann® Emdogain will result in significantly higher Clinical Attachment Level (CAL) gain compared to periodontal surgery without Straumann® Emdogain.
The following secondary endpoints will be evaluated during the study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emdogain | Experimental | Periodontal surgery with the additional use of Straumann® Emdogain |
|
| Periodontal Surgery | Active Comparator | Periodontal surgery alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emdogain | Device | Periodontal surgery with the additional use of Straumann® Emdogain |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Attachment Level | The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Margin (GM) From Baseline to 12 Months | GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ. |
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Inclusion Criteria:
Exclusion Criteria:
Pre-surgical exclusion criteria:
Secondary exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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The recruitment was terminated prematurely.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emdogain | Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain |
| FG001 | Periodontal Surgery | Periodontal surgery alone Periodontal surgery: Periodontal surgery alone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emdogain | Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain |
| BG001 | Periodontal Surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clinical Attachment Level | The change in Clinical Attachment Level (CAL) from Baseline to 12 Months. CAL measurements will be derived from the Probing Pocket Depth (PPD) and Gingival Margin (GM) measurements as follows: CAL = PPD - GM. | Posted | Mean | Standard Deviation | mm | 12 Months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emdogain | Periodontal surgery with the additional use of Straumann® Emdogain Emdogain: Periodontal surgery with the additional use of Straumann® Emdogain |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth hypersensitivity | General disorders |
Early termination leading to small numbers of subjects analyzed. This sponsor decision was based on commercial reasons and not linked to any safety concerns or new scientific knowledge.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michel Mallaun | Straumann | michel.mallaun@straumann.com |
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| ID | Term |
|---|---|
| D017622 | Periodontal Attachment Loss |
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D055093 | Periodontal Atrophy |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Periodontal surgery |
| Procedure |
Periodontal surgery alone |
|
| 12 months after baseline |
| Change in Probing Pocket Depth (PPD) From Baseline to 12 Months | PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth. | 12 months after baseline |
| Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline | Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment:
| 4 weeks after baseline |
| Comparison of Post-surgical Pain at 4 Weeks After Baseline | Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome | 4 weeks after baseline |
| Change in Bleeding on Probing (BoP) From Baseline to 12 Months | The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP. | 12 months after baseline |
| Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months | RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH. | 12 months after baseline |
| Change in Plaque Index (PI) From Baseline to 12 Months | The PI was recorded according to O'Leary et al. [1972] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI. | 12 months after baseline |
Periodontal surgery alone
Periodontal surgery: Periodontal surgery alone
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Gingival Margin (GM) From Baseline to 12 Months | GM was measured by recording the distance from the Cemento-Enamel Junction (CEJ) to the margin of the gingiva at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesio-oral, mid-oral, disto-oral) on the study teeth. Negative value for GM indicates gingival recession. A positive value for the GM indicates the gingiva was covering the CEJ. | Posted | Mean | Standard Deviation | mm | 12 months after baseline |
|
|
|
| Secondary | Change in Probing Pocket Depth (PPD) From Baseline to 12 Months | PPD was measured before the area is anaesthetized by recording the distance from the gingival margin to the bottom of the probable pocket at 6 sites (mesio-vestibular, mid-vestibular, disto-vestibular, mesiooral, mid-oral, and disto-oral) on the study teeth.Negative value for PPD indicates reduction of pocket depth. | Posted | Mean | Standard Deviation | mm | 12 months after baseline |
|
|
|
| Secondary | Early Wound Healing Index (EHI) Assessment at 4 Weeks After Baseline | Postoperative wound healing was assessed by the EHI according to Wachtel et al. [2003] by visual assessment:
| Posted | Number | percentage of EHI category 1 | 4 weeks after baseline |
|
|
|
| Secondary | Comparison of Post-surgical Pain at 4 Weeks After Baseline | Visual Analog Scale (VAS) for post-surgical pain, minimum value=0, maximum value=10, higher score means worse outcome | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after baseline |
|
|
|
| Secondary | Change in Bleeding on Probing (BoP) From Baseline to 12 Months | The presence of BoP was recorded as a binary response on 6 sites (mesio-vestibular, midvestibular, disto-vestibular, mesio-oral, mid-oral, and disto-oral) on the study teeth. The percentage of positive events per total probing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in BoP. | Posted | Number | percentage of BoP change | 12 months after baseline |
|
|
|
| Secondary | Change in Root Dentin Hypersensitivity (RDH) From Baseline to 12 Months | RDH was examined by physical testing using cold air as a stimulus. The percentage of positive events per total testing sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in RDH. | Posted | Number | percentage of RDH change | 12 months after baseline |
|
|
|
| Secondary | Change in Plaque Index (PI) From Baseline to 12 Months | The PI was recorded according to O'Leary et al. [1972] as a binary response at the mesial, distal, facial and lingual surfaces on the study teeth. The percentage of positive events per total sites was calculated for each group. The outcome measure was the change between baseline and 12 months. Negative values indicate a decrease in PI. | Posted | Number | percentage of PI change | 12 months after baseline |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
| EG001 | Periodontal Surgery | Periodontal surgery alone Periodontal surgery: Periodontal surgery alone | 0 | 17 | 1 | 17 |
| Aphthous ulcer | General disorders |
|
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