Guided Tissue RegenerationNCT06252935
Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
A study testing FormaAid and Bio-Gide in people with Guided Tissue Regeneration and Collagen Membrane, run by Maxigen Biotech Inc. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Guided Tissue Regeneration, Collagen Membrane, Dental Diseases
- What is being tested?
- FormaAid and Bio-Gide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, Taiwan, 114202
Attending Physician, +886920776432, peter71130000@hotmail.com
About this study
Official title: A Single-Center, Evaluator-blind, Randomized Control Study to Assess the Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
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.
Read more
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.
Read the detailed description
This study is conducted as a randomized controlled clinical trial regarding the use of two different marketed collagen membrane with freeze-dried bone allograft (FDBA) in treatment of periodontal intrabony defects. Collagen membrane acts as a barrier that prevents soft tissue (gums) from growing into the area where bone regeneration is desired. This allows the bone and other necessary tissues to regenerate more effectively. Sutures are removed 14 days after the surgery. Patients are then followed up at 5, 13- and 27-weeks post-surgery for Gl, PI, GR, PPD, and CAL to evaluate the tissue condition. The cone beam computed tomography (CBCT) and the X-ray radiographic evaluation will be assess in this study twice before and after treatment week 27 on the investigational site. And all subjects will receive intra-oral scanning with an intra-oral scanner at baseline and week 5, 13, 27 follow-up visits to assess the gingival tissue thickness and gingival tissue volume change. Safety data and adverse events would be recorded throughout the study.
- Being tested
- FormaAid, Bio-Gide
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FormaAidDevice
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.
Bio-GideDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bio-Gide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 27
Secondary outcomes (8)
Difference of periodontal pocket depth (PPD)
PPD is assessed by periodontal probing to detect and measure the distance from gingival margin to the bottom of the defect. Difference from baseline in periodontal pocket depth (PPD) Week 27 after the surgery.
Measured: Week 0, Week 27
Difference of gingival recession (GR)
GR is assessed by periodontal probing to detect and measure the distance from the gingival margin to the cemento-enamel junction (CEJ). Difference from baseline in periodontal Gingival recession (GR) Week 27 after the surgery.
Measured: Week 0, Week 27
Difference of gingival index (GI)
Difference from baseline in periodontal status: Gingival Index (GI) Week 5, 13, and 27 after the surgery. GI is evaluated according to Löe \& Silness.
- 0: Normal gingiva.
- 1: Mild inflammation Slight change in color, slight oedema. No bleeding on probing.
- 2: Moderate inflammation: Redness, oedema and glazing. Bleeding on probing.
- 3: Severe inflammation: Marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
Measured: Week 0, Week 5, Week13, Week 27
Difference of plaque index (PI)
Difference from baseline in periodontal status: Plaque Index (PI) Week 5, 13, and 27 after the surgery. PI is evaluated by using the grading definition of Silness \& Löe.
- 0: No plaque in the gingival area.
- 1: A film of plaque adhering to the free gingival margin and adjacent area of the tooth The plaque may only be recognized by running a probe across the tooth surface.
- 2: Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
- 3: Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: Week 0, Week 5, Week13, Week 27
Difference of intrabony defect height
Difference from baseline in intrabony defect height (IDH) with X ray images Week 27 after the surgery. Bone Fill (%) is defined as the percentage change in IDH, following the equation: ((IDH week27 - IDH baseline)/ IDH baseline)*100%
Measured: Week 0, Week 27
Difference of gingival soft tissue
Difference from baseline in gingival soft tissue with an intra-oral scanning that gingival tissue thickness Week 5, 13, and 27 after the surgery. The baseline scanned data of all subjects would be superimposed with the corresponding scanned data obtained during re-evaluation to ensure the teeth are in the correct alignment and generate thickness change data.
Measured: Week 0, Week 5, Week13, Week 27
Incidence of device related complications
The relationship of adverse events (AEs) to the investigational product will be assessed on four levels: highly probable, probable, possible, unlikely, and unrelated. The percentage of patients who experience AEs caused by the investigational product will be calculated to represent the incidence of device related complications.
Measured: Week 0 to Week 27
Incidence of adverse event of special interest (AESI) / serious adverse event (SAE)
The incidence will be calculated to represent the percentage of patients who experience AESI or SAE. The AESI refer to specific adverse events in the GTR surgical site, including wound dehiscence, membrane exposure, wound infection, postoperative infection, operation site inflammation, pain, abscess, allergy, swelling and delayed healing. And the SAE is considered as adverse event that interrupt a subject's usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually incapacitating.
Measured: Week 0 to Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start30 Jul 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Tissue RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Sponsor
- Investigators
- Cheng-En Sung, Doctor, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252935
- Sponsor's protocol ID
- MBI-FA-202301
- Status last verified
- May 2025
- First submitted
- 2 Feb 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Evaluator-blind, Randomized Control Study to Assess the Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
- ClinicalTrials.gov ID
- NCT06252935
- Acronym / sponsor ID
- MBI-FA-202301
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is conducted as a randomized controlled clinical trial regarding the use of two different marketed collagen membrane with freeze-dried bone allograft (FDBA) in treatment of periodontal intrabony defects. Collagen membrane acts as a barrier that prevents soft tissue (gums) from growing into the area where bone regeneration is desired. This allows the bone and other necessary tissues to regenerate more effectively. Sutures are removed 14 days after the surgery. Patients are then followed up at 5, 13- and 27-weeks post-surgery for Gl, PI, GR, PPD, and CAL to evaluate the tissue condition. The cone beam computed tomography (CBCT) and the X-ray radiographic evaluation will be assess in this study twice before and after treatment week 27 on the investigational site. And all subjects will receive intra-oral scanning with an intra-oral scanner at baseline and week 5, 13, 27 follow-up visits to assess the gingival tissue thickness and gingival tissue volume change. Safety data and adverse events would be recorded throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FormaAid group | Experimental | Device: FormaAidPatients 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. |
| Bio-Gide group | Active comparator | Device: Bio-GidePatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FormaAidFormaAid 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. | Device | FormaAid group |
| Bio-GideBio-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. | Device | Bio-Gide group |
Primary outcome
Difference of clinical attachment level (CAL)
Time frame: Week 0, Week 27
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.
8 secondary outcomes
Difference of periodontal pocket depth (PPD)
Time frame: Week 0, Week 27
Difference of gingival recession (GR)
Time frame: Week 0, Week 27
Difference of gingival index (GI)
Time frame: Week 0, Week 5, Week13, Week 27
Difference of plaque index (PI)
Time frame: Week 0, Week 5, Week13, Week 27
Difference of intrabony defect height
Time frame: Week 0, Week 27
Difference of gingival soft tissue
Time frame: Week 0, Week 5, Week13, Week 27
Incidence of device related complications
Time frame: Week 0 to Week 27
Incidence of adverse event of special interest (AESI) / serious adverse event (SAE)
Time frame: Week 0 to Week 27
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheng-En Sung, Doctor principal investigator
Tri-Service General Hospital (TSGH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FormaAid and Bio-Gide in people with Guided Tissue Regeneration and Collagen Membrane, run by Maxigen Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LiRong Chen (+88633287222 ext. 1250, lirong.chen@mbi.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of clinical attachment level (CAL) (time frame: Week 0, Week 27). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.