Using collagen membrane to improve periodontal regeneration
A Single-Center, Evaluator-blind, Randomized Control Study to Assess the Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
This study is testing if a new collagen membrane called FormaAid® can help people with gum disease heal better after surgery compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Maxigen Biotech Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei, Taiwan) |
| Trial ID | NCT06252935 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of the collagen membrane FormaAid® in treating periodontal regeneration through guided tissue regeneration (GTR). Participants will be randomly assigned to receive either FormaAid or a control product, Bio-Gide, during GTR surgery. The study will assess various periodontal health indicators, including clinical attachment level and pocket depth, at multiple follow-up visits. Additionally, radiographic evaluations will be conducted to measure changes in bone and tissue conditions over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with specific periodontal conditions requiring GTR and who are non-smokers.
Not a fit: Patients with less severe periodontal disease or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance periodontal regeneration and improve oral health outcomes for patients with periodontal disease.
How similar studies have performed: Previous studies have shown promising results with similar collagen membrane approaches in periodontal treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taipei, Taiwan
- Tri-Service General Hospital — Taipei, Taiwan, Taiwan (Recruiting)
Study contacts
- Principal investigator: Cheng-En Sung, Doctor — Tri-Service General Hospital
- Study coordinator: LiRong Chen
- Email: lirong.chen@mbi.com.tw
- Phone: +88633287222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.