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

Launched by MAXIGEN BIOTECH INC. · Feb 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment method for people with gum disease, specifically using a special collagen membrane called FormaAid® to help regenerate lost gum tissue. The researchers want to see how effective and safe this treatment is compared to another product called Bio-Gide. They will measure various aspects like how well the gums heal, the depth of gum pockets, and the thickness of the gum tissue over several weeks after the surgery.

To participate, you need to be between 18 and 70 years old and a non-smoker. You should have specific types of gum disease with deep gum pockets and certain bone defects as confirmed by X-rays. Participants will undergo a procedure called guided tissue regeneration (GTR) surgery and will have follow-up visits at weeks 3, 5, 13, and 27. Your involvement will help researchers understand the benefits and safety of this new treatment for gum disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 70 years old, male or female
• • Non current smoker: A person who has not smoked more than 100 cigarettes from the past to the present and has not smoked in the last 30 days.
• • Patients who have decided to pay at their own expense and require guided tissue regeneration (GTR) for periodontal regeneration
• • The defect morphology of intrabony defects is 2 or 3 wall intrabony defect.
• • Periodontal pocket depth ≥ 5mm (probing periodontal depth, PPD, distance from gingival margin to the bottom of the defect).
• • The height of the bone defect in the X ray image is ≥ 3mm (according to the X ray film intraosseous defect)
• • The diagnosis of periodontal disease is stage III with either grade B or C.
• • Patients who are willing to adhere to the study protocol and sign the informed consent form.
• • Willing to accept evaluation during the trial period and return to clinic and treatment.
• • Not a person subject to a sentence of guardianship or subject to judicial guardians.
• Exclusion Criteria:
• • Have a history of severe allergies or be allergic to collagen.
• • Those who are known to be positive for human immunodeficiency virus.
• • Poorly controlled diabetes (untreated or unstable disease status), blood test measurement of glycated hemoglobin greater than 7%
• • Undergoing chemotherapy three months before agreeing to this experiment.
• • Patients undergoing meat product desensitization treatment.
• • Have a documented history of osteoporosis.
• • Chronic disease, hypertension, hyperlipidemia, cardiovascular disease, and stroke not properly controlled (untreated or unstable disease condition) judged by the investigator at screening.
• • Suffering from autoimmune diseases or connective tissue diseases, such as systemic lupus erythematosus or dermatomyositis.
• • Coagulation disorder, lab test prothrombin time (PT) \> 12 sec , or the use of anticoagulants that affects surgery judged by the investigator at screening.
• • The tooth for which guided tissue regeneration (GTR) surgery is to be performed is determined to be furcation involved by investigator from image evaluation
• • The tooth for which guided tissue regeneration (GTR) surgery is to be performed is considered unhealthy, exhibiting conditions such as apical lesion, needed endodontic therapy tooth, tooth fracture, etc. etc., as judged by the investigator f rom image evaluation
• • Oral mucosal abnormalities or poor periodontal health, making it unsuitable for GTR surgical treatment, such as white spots, erythema, oral submucosal fibrosis, lichen planus, verrucous hyperplasia, inflammation, infection, etc. judged by the investigator at screening.
• • Those whose periodontal cleaning is not in good condition or who are unable to cooperate with periodontal cleaning. Plaque control index (O'Leary index) \>15%
• • The mobility of the teeth that are to undergo guided tissue regeneration (GTR) surgery is greater than or equal to
• • Teeth that are to undergo guided tissue regeneration (GTR) surgery have incomplete adjacent teeth on both sides, such as dental prostheses, crowns or bridges, artificial dental implants, or metal fillings. materials, etc., so as to affect the image evaluation.
• • Others who are not suitable to participate in or continue this clinical trial as assessed by a physician.