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
Qualifiers
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
Treatments tested in this trial
- FormaAid
- Bio-Gide
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Maxigen Biotech Inc.
Lead sponsor
Tri-Service General Hospital
Collaborator
Source ClinicalTrials.gov