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| Name | Class |
|---|---|
| Tri-Service General Hospital (TSGH) | OTHER |
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The goal of this clinical trial is to evaluate clinically and radiographically effectiveness and products safety of the collagen membrane (FormaAid®) in the treatment of periodontal regeneration using guided tissue regeneration (GTR) performed by the trained periodontists. The main question it aims to answer are:
Participants will be randomized into either experiment group or control group, undergo guided tissue regeneration (GTR) surgery at week 1, and re-visited on week 3, 5, 13 and 27 after the GTR surgery.
Researchers will compare if the test product is non-inferior to Bio-Gide.
This study is conducted as a randomized controlled clinical trial regarding the use of two different marketed collagen membrane with freeze-dried bone allograft (FDBA) in treatment of periodontal intrabony defects. Collagen membrane acts as a barrier that prevents soft tissue (gums) from growing into the area where bone regeneration is desired. This allows the bone and other necessary tissues to regenerate more effectively. Sutures are removed 14 days after the surgery. Patients are then followed up at 5, 13- and 27-weeks post-surgery for Gl, PI, GR, PPD, and CAL to evaluate the tissue condition. The cone beam computed tomography (CBCT) and the X-ray radiographic evaluation will be assess in this study twice before and after treatment week 27 on the investigational site. And all subjects will receive intra-oral scanning with an intra-oral scanner at baseline and week 5, 13, 27 follow-up visits to assess the gingival tissue thickness and gingival tissue volume change. Safety data and adverse events would be recorded throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FormaAid group | Experimental | Patients with intrabony defects are randomly assigned to receive either FormaAid collagen membrane or Geistlich Bio-Gide (control)before the GTR. And then treated with GTR surgery, the surgical procedure involves a full-thickness flap, the affected area is cleaned, and the damaged or diseased tissue may be removed. The allograft will be then placed into the defect and the collagen membrane is then trimmed and adapted over the defect. After all the treatment is done, 5-0 nylon suture will be used for the flap closure. |
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| Bio-Gide group | Active Comparator | Patients with intrabony defects are randomly assigned to receive either FormaAid collagen membrane or Geistlich Bio-Gide (control)before the GTR. And then treated with GTR surgery, the surgical procedure involves a full-thickness flap, the affected area is cleaned, and the damaged or diseased tissue may be removed. The allograft will be then placed into the defect and the collagen membrane is then trimmed and adapted over the defect. After all the treatment is done, 5-0 nylon suture will be used for the flap closure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FormaAid | Device | FormaAid is mainly composed of pure collagen extracted from bovine tendon, it is fabricated in the form of highly dense collagen matrix without chemical cross-linking to act as a barrier excluding epithelium. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of clinical attachment level (CAL) | Difference from baseline in periodontal clinical attachment level (CAL) with a periodontal probe Week 27 after the surgery. CAL is defined as periodontal probing depth plus gingival recession. | Week 0, Week 27 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of periodontal pocket depth (PPD) | PPD is assessed by periodontal probing to detect and measure the distance from gingival margin to the bottom of the defect. Difference from baseline in periodontal pocket depth (PPD) Week 27 after the surgery. | Week 0, Week 27 |
| Difference of gingival recession (GR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LiRong Chen | Contact | +88633287222 | 1250 | lirong.chen@mbi.com.tw |
| Name | Affiliation | Role |
|---|---|---|
| Cheng-En Sung, Doctor | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Recruiting | Taipei | Taiwan | 114202 | Taiwan |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Bio-Gide | Device | Bio-Gide is a bilayer collagen membrane made of porcine collagen, permits prompt and homogeneous vascularization and so brings about optimal tissue integration and wound stabilization. |
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GR is assessed by periodontal probing to detect and measure the distance from the gingival margin to the cemento-enamel junction (CEJ). Difference from baseline in periodontal Gingival recession (GR) Week 27 after the surgery. |
| Week 0, Week 27 |
| Difference of gingival index (GI) | Difference from baseline in periodontal status: Gingival Index (GI) Week 5, 13, and 27 after the surgery. GI is evaluated according to Löe & Silness.
| Week 0, Week 5, Week13, Week 27 |
| Difference of plaque index (PI) | Difference from baseline in periodontal status: Plaque Index (PI) Week 5, 13, and 27 after the surgery. PI is evaluated by using the grading definition of Silness & Löe.
| Week 0, Week 5, Week13, Week 27 |
| Difference of intrabony defect height | Difference from baseline in intrabony defect height (IDH) with X ray images Week 27 after the surgery. Bone Fill (%) is defined as the percentage change in IDH, following the equation: ((IDH week27 - IDH baseline)/ IDH baseline)*100% | Week 0, Week 27 |
| Difference of gingival soft tissue | Difference from baseline in gingival soft tissue with an intra-oral scanning that gingival tissue thickness Week 5, 13, and 27 after the surgery. The baseline scanned data of all subjects would be superimposed with the corresponding scanned data obtained during re-evaluation to ensure the teeth are in the correct alignment and generate thickness change data. | Week 0, Week 5, Week13, Week 27 |
| Incidence of device related complications | The relationship of adverse events (AEs) to the investigational product will be assessed on four levels: highly probable, probable, possible, unlikely, and unrelated. The percentage of patients who experience AEs caused by the investigational product will be calculated to represent the incidence of device related complications. | Week 0 to Week 27 |
| Incidence of adverse event of special interest (AESI) / serious adverse event (SAE) | The incidence will be calculated to represent the percentage of patients who experience AESI or SAE. The AESI refer to specific adverse events in the GTR surgical site, including wound dehiscence, membrane exposure, wound infection, postoperative infection, operation site inflammation, pain, abscess, allergy, swelling and delayed healing. And the SAE is considered as adverse event that interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating. | Week 0 to Week 27 |