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Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Sponsor: Maxigen Biotech Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-07-30
Completion Date
2025-10-31
Last Updated
2025-05-09
Healthy Volunteers
No
Interventions
FormaAid
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.
Bio-Gide
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.
Locations (1)
Tri-Service General Hospital
Taipei, Taiwan, Taiwan