Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMaxigen Biotech Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FormaAid
DeviceFormaAid 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-Gide
DeviceBio-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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: FormaAid groupExperimental treatment 1 intervention
Group B: Bio-Gide groupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Week 0, Week 27Secondary outcomes
1
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.
Time frame
Week 0, Week 272
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.
Time frame
Week 0, Week 273
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.
Time frame
Week 0, Week 5, Week13, Week 274
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.
Time frame
Week 0, Week 5, Week13, Week 27Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Maxigen Biotech Inc.
Lead sponsor
Tri-Service General Hospital
Collaborator
Source ClinicalTrials.gov