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The aim of this controlled study is to assess the clinical outcomes and patient reported outcomes of using minimally invasive surgical procedure with Straumann Emdogain as an adjunct (test treatment) or without Straumann Emdogain (control treatment).
The aim of the study will be achieved through the following primary and secondary objectives. The primary objective is to evaluate the regenerative potential of Straumann Emdogain by comparing the change in clinical attachment level from baseline to 12 months between the test and control arms. The regenerative potential of Straumann Emdogain will also be assessed by comparing the changes in gingival margins, changes in average probing pocket depth, changes in full mouth plaque score, changes in bleeding on probing, and changes in root dentin hypersensitivity from baseline to 12 months between the test and control arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test (with Emdogain) | Active Comparator | Scaling and root planing with Emdogain |
|
| Control (without Emdogain) | Other | Scaling and root planing without Emdogain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing | Procedure | Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical Attachment Levels (CAL) | CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms. | Baseline and 12 Month Follow-Up Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gingival Margin (GM) | GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms. | Baseline and 12 Month Follow-Up Visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela K McClain, DDS | Periodontics and Implant Dentistry | Principal Investigator |
| Veronique Benhamou, DDS | Clinique Paro Excellence | Principal Investigator |
| Jennifer H Doobrow, DMD | Periodontal & Implant Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Periodontal and Implant Associates, Inc. | Cullman | Alabama | 35055 | United States | ||
| Periodontics and Implant Dentistry |
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Oversight. 1 extra patient was enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test (With Emdogain) | Scaling and root planing with Emdogain Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw |
| FG001 | Control (Without Emdogain) | Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants assigned to receive both interventions (i.e., control and test) in different quadrants of the jaw. - Test Treatment (Scaling and root planing with Emdogain): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. Emdogain application: Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw. - Control Treatment (Scaling and root planing): Scaling and root planing: Using minimally invasive surgical procedure (scaling and root planing) to treat one contra-lateral quadrant in subject's jaw. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change in Clinical Attachment Levels (CAL) | CAL will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of CAL from baseline measurements at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of CAL for test and control treatment arms. | The ITT data set with imputation of missing values (five CAL values were missing at 12 month follow-up and were replaced with values from 9 month follow-up). | Posted | Mean | Standard Deviation | mm | Baseline and 12 Month Follow-Up Visit |
|
Up to 12 months.
All participants received both interventions and adverse events were not collected with regard to separate intervention.
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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 | All Participants | All Participants | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer diagnosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Subject diagnosed with breast cancer. Unrelated to device or procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus Infection | Infections and infestations | Non-systematic Assessment | Subject reported sinus infection. Unrelated to device or procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Manfred Klasser | GWD Consult | +49 6108 825 65 20 | manfred.klasser@gwd-consult.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2018 | Jul 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| C109069 | enamel matrix proteins |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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| Scaling and root planing without Emdogain | Procedure | Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw. |
|
| Emdogain application | Device | Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw |
|
| Change in Pocket Probing Depth (PPD) | PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms. | Baseline and 12 Month Follow-Up Visit |
| Change in Full Mouth Plaque Score (FMPS) | FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined. | Baseline and 12 Month Follow-Up Visit |
| Change in Bleeding on Probing (BoP) | For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline. | Baseline and 12 Month Follow-Up Visit |
| Change in Root Dentin Hypersensitivity | Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild). | Baseline and 12 Month Follow-Up Visit |
| Change in Post-surgical Pain | Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms. | 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery |
| Aurora |
| Colorado |
| 80012-3202 |
| United States |
| Clinique Paro Excellence | Montreal | Quebec | H3B 3A7 | Canada |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz | 55131 | Germany |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control (Without Emdogain) | Scaling and root planing without Emdogain Scaling and root planing without Emdogain: Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw. |
|
|
| Secondary | Change in Gingival Margin (GM) | GM will be measured in millimeters on the study teeth at 6 locations. Outcome is mean change of GM from baseline at surgery to 12-months-post surgery, taken from the deepest pocket of a patient's test and control teeth measured at baseline. Analysis will compare the mean change of GM for test and control treatment arms. | from the ITT dataset. Missing data was not entered. | Posted | Mean | Standard Deviation | mm | Baseline and 12 Month Follow-Up Visit |
|
|
|
| Secondary | Change in Pocket Probing Depth (PPD) | PPD will be measured in millimeters on the study teeth in 6 locations. Outcome is mean change of PPD from baseline at surgery to 12-months post-surgery, taken from the deepest pocket of a patient's test and control teeth at baseline. Analysis will compare the mean change of PPD for test and control treatment arms. | ITT dataset. | Posted | Mean | Standard Deviation | mm | Baseline and 12 Month Follow-Up Visit |
|
|
|
| Secondary | Change in Full Mouth Plaque Score (FMPS) | FMPS will be calculated based on the number of tooth surfaces with plaque over the total number of tooth surfaces x 100. The value is presented as a percent. The difference in FMPS between 12 months and baseline will be determined. | ITT data set. | Posted | Number | Full Mouth Plaque Score | Baseline and 12 Month Follow-Up Visit | Tooth surfaces | Tooth surfaces |
|
|
|
| Secondary | Change in Bleeding on Probing (BoP) | For the categorical variable BoP, the frequency of bleeding (present or absent) will be counted (absolute and in percent) over all measured sites around the identified study teeth for each treatment group. The results will be compared between the 12-month follow-up and baseline. | ITT data set. | Posted | Count of Units | Sites | Baseline and 12 Month Follow-Up Visit | Sites | Sites |
|
|
|
| Secondary | Change in Root Dentin Hypersensitivity | Presence of root dentin hypersensitivity will be recorded as "none" (no reaction from the subject), "mild" (sensible with no pain), "moderate" (sensible with slight pain), or "severe" (sensible with pain that persists for a while) after a conventional air blast is applied to the study tooth. Changes in the frequency of categories will be determined and compared between the two treatment arms. An improvement is defined as a decreased reaction (for example, severe to mild), a deterioration is defined as increased reaction (for example, none to moderate), and unchanged is no change to reaction (for example, mild to mild). | ITT data set study teeth. Baseline collected at either visit 1 or visit 2 based on different versions of CIP. | Posted | Count of Units | Study Teeth | Baseline and 12 Month Follow-Up Visit | Study Teeth | Study Teeth |
|
|
|
| Secondary | Change in Post-surgical Pain | Post-surgical pain will be measured on a 100 millimeter visual analog scale. The range is 0 (no pain) to 99 (nearly maximum pain). The lower the value, the better the outcome. The subjects will be instructed to mark their level of pain on a line for both the test quadrant and the control quadrant. The average change in pain level will be determined and compared between the two arms. | ITT dataset. | Posted | Mean | Standard Deviation | mm | 1-2 days post surgery, 1 week post surgery, and 2 weeks post surgery |
|
|
|
| 51 |
| 1 |
| 51 |
| 15 |
| 51 |
|
|
| Extensive tooth decay | General disorders | Non-systematic Assessment | Extensive tooth decay site #31. Unrelated to device or procedure. |
|
| Cold/Flu | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Cold/Flu. Unrelated to device or procedure. |
|
| Mild discomfort when chewing | General disorders | Systematic Assessment | mild discomfort with chewing. Possibly related to procedure. |
|
| Retrained bony sequestrum | General disorders | Non-systematic Assessment | Retained bony sequestrum. Unrelated to device or procedure. |
|
| Generalized sensation of burning mouth | General disorders | Non-systematic Assessment | Generalized sensation of burning mouth. Unrelated to device or procedure. |
|
| Itching skin reaction gum | General disorders | Systematic Assessment | Itching skin reaction gum. Possibly related to device or procedure. |
|
| Itching skin reaction neck area, external | Skin and subcutaneous tissue disorders | Systematic Assessment | Itching skin reaction neck area, external, no pain. Possibly related to device. |
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| Fracture of Veneer #21 | General disorders | Non-systematic Assessment | Fracture of veneer #21. Unrelated to device or procedure. |
|
| Hematoma | General disorders | Systematic Assessment | Hematoma right side above tooth # 5 and #6. Approx 2-3 cms big. No pain. Definitely related to procedure. |
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| Tooth fracture #23 | General disorders | Non-systematic Assessment | Tooth Fracture #23. Unrelated to device or procedure. |
|
| Apical periodontitis | General disorders | Non-systematic Assessment | Apical periodontitis. Unrelated to device or procedure. |
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| Abscess on extracted tooth #20 | General disorders | Non-systematic Assessment | Abscess on tooth #20. Not study tooth. Unrelated to device or procedure. |
|
| Bleeding and mobility at #24 and 28 | General disorders | Non-systematic Assessment | Bleeding and mobility at teeth #24 and #28. Unrelated to device or procedure. |
|
| Loosening of bridge | General disorders | Non-systematic Assessment | Loosening of bridge. Unrelated to device or procedure. |
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| Sensitivity to cold teeth # 4,5,7 and 9-11 | General disorders | Systematic Assessment | Sensitivity to cold teeth # 4,5,7 and 9-11. Possibly related to procedure. |
|
| Unclear tooth complaint #5 and #6 | General disorders | Non-systematic Assessment | Unclear tooth complaint #5 and #6. Unrelated to device or procedure. |
|
| Restoration prosthetic problem | General disorders | Non-systematic Assessment | Restoration prosthetic problem. Unrelated to device or procedure. |
|
| Hypersensitivity to pain # 22 and 25-28 | General disorders | Systematic Assessment | Hypersensitivity to pain #22 and 25-28. Possibly related to procedure. |
|
| Sensitivity to warmth and cold # 19,21,22,25,27-29 | General disorders | Systematic Assessment | Sensitivity to warmth and cold #19,21,22,25,27-29. Definitely related to procedure. |
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| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
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| 12 Month Follow Up |
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| Baseline sites without bleeding |
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| 12 month sites with bleeding |
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| 12 month sites without bleeding |
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| Unchanged Root Dentin Hypersensitivity |
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| Pain Level 2 weeks post sx. |
|