Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regener… (NCT06252935) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Taiwan60 participantsStarted 2024-07-30
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, hype…