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Tests treatment safety and results for Guided Tissue Regeneration
Official title Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
ClinicalTrials.gov ID: NCT06252935
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join 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).
You likely can't join 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.
See the full eligibility criteria
Who can 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)
- 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.
What rules you out
- 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...
- 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...
- 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...
- Others who are not suitable to participate in or continue this clinical trial as assessed by a physician.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.