NCT06252935 Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2024-07-30 with a primary completion date of 2025-04-30.

Brief 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.

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.

Contact & Investigator

Frequently Asked Questions

Related Trials