Actively Recruiting
Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Led by Maxigen Biotech Inc. · Updated on 2025-05-09
60
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
M
Maxigen Biotech Inc.
Lead Sponsor
T
Tri-Service General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old, male or female
- Non current smoker: Has not smoked more than 100 cigarettes in lifetime and not smoked in last 30 days
- Patients who require guided tissue regeneration (GTR) for periodontal regeneration and will pay at their own expense
- Intrabony defects with 2 or 3 walls
- Periodontal pocket depth of 5 mm or greater
- Bone defect height of 3 mm or greater on X-ray
- Diagnosis of stage III periodontal disease with grade B or C
- Willingness to follow study protocol, provide informed consent, and attend all evaluations
- Not under legal guardianship or judicial guardianship
You will not qualify if you...
- History of severe allergies or allergy to collagen
- Known HIV positive status
- Poorly controlled diabetes with glycated hemoglobin greater than 7%
- Chemotherapy within 3 months before enrollment
- Undergoing meat product desensitization treatment
- Documented osteoporosis
- Uncontrolled chronic diseases such as hypertension, hyperlipidemia, cardiovascular disease, or stroke
- Autoimmune or connective tissue diseases like systemic lupus erythematosus or dermatomyositis
- Coagulation disorders or use of anticoagulants affecting surgery
- Furcation involvement of the tooth planned for GTR surgery
- Unhealthy tooth conditions requiring endodontic therapy or with fractures
- Oral mucosal abnormalities or poor periodontal health unsuitable for GTR
- Poor plaque control with plaque index over 15%
- Tooth mobility greater than or equal to a specified level
- Teeth with incomplete adjacent teeth or prosthetic restorations affecting imaging
- Any other conditions making participation unsuitable as judged by physician
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tri-Service General Hospital
Taipei, Taiwan, Taiwan, 114202
Actively Recruiting
Research Team
L
LiRong Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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