Effectiveness & Safety of Collagen Membrane (FormaAid®) in the Treatment

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06252935
Study type	Interventional
Source	Maxigen Biotech Inc.
Contact	LiRong Chen
Phone	+88633287222
Email	lirong.chen@mbi.com.tw
Status	Not yet recruiting
Phase	N/A
Start date	March 12, 2024
Completion date	October 31, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms