Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-30 @ 2:14 AM
Study NCT ID:
NCT06252935
Status:
RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Sponsor:
Maxigen Biotech Inc.
Organization:
Study Overview
Official Title:
A Single-Center, Evaluator-blind, Randomized Control Study to Assess the Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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:
* The difference of periodontal status: clinical attachment level (CAL), periodontal pocket depth (PPD), gingival recession (GR), gingival Index (GI) and plaque index (PI).
* The difference of intrabony defect height.
* The difference of gingival tissue thickness and gingival tissue volume.
* The incidences of safety indicators.
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.
* The difference of periodontal status: clinical attachment level (CAL), periodontal pocket depth (PPD), gingival recession (GR), gingival Index (GI) and plaque index (PI).
* The difference of intrabony defect height.
* The difference of gingival tissue thickness and gingival tissue volume.
* The incidences of safety indicators.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: