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

NCT06252935 | Recruiting

• 1 other identifier: MBI-FA-202301
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Guided Tissue Regeneration; Collagen Membrane; Dental Diseases

Outcome Measures

Primary Outcomes (1)

• Difference of clinical attachment level (CAL)

  Difference from baseline in periodontal clinical attachment level (CAL) with a periodontal probe Week 27 after the surgery. CAL is defined as periodontal probing depth plus gingival recession.

  Week 0, Week 27

Secondary Outcomes (8)

• Difference of periodontal pocket depth (PPD)

  Week 0, Week 27

• Difference of gingival recession (GR)

  Week 0, Week 27

• Difference of gingival index (GI)

  Week 0, Week 5, Week13, Week 27

• Difference of plaque index (PI)

  Week 0, Week 5, Week13, Week 27

• Difference of intrabony defect height

  Week 0, Week 27

Study Arms (2)

FormaAid group

EXPERIMENTAL

Patients with intrabony defects are randomly assigned to receive either FormaAid collagen membrane or Geistlich Bio-Gide (control)before the GTR. And then treated with GTR surgery, the surgical procedure involves a full-thickness flap, the affected area is cleaned, and the damaged or diseased tissue may be removed. The allograft will be then placed into the defect and the collagen membrane is then trimmed and adapted over the defect. After all the treatment is done, 5-0 nylon suture will be used for the flap closure.

Device: FormaAid

Bio-Gide group

ACTIVE COMPARATOR

Patients with intrabony defects are randomly assigned to receive either FormaAid collagen membrane or Geistlich Bio-Gide (control)before the GTR. And then treated with GTR surgery, the surgical procedure involves a full-thickness flap, the affected area is cleaned, and the damaged or diseased tissue may be removed. The allograft will be then placed into the defect and the collagen membrane is then trimmed and adapted over the defect. After all the treatment is done, 5-0 nylon suture will be used for the flap closure.

Device: Bio-Gide

Interventions

FormaAid DEVICE

FormaAid is mainly composed of pure collagen extracted from bovine tendon, it is fabricated in the form of highly dense collagen matrix without chemical cross-linking to act as a barrier excluding epithelium.

FormaAid group

Bio-Gide DEVICE

Bio-Gide is a bilayer collagen membrane made of porcine collagen, permits prompt and homogeneous vascularization and so brings about optimal tissue integration and wound stabilization.

Bio-Gide group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead
• Tri-Service General Hospital: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 114202, Taiwan

RECRUITING

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Cheng-En Sung, Doctor

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LiRong Chen

CONTACT

+88633287222; lirong.chen@mbi.com.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: July 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)