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RECRUITING
NCT06252935
NA

Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration

Sponsor: Maxigen Biotech Inc.

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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