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Effectiveness and Safety of Collagen Membrane (FormaAid®) in the Treatment of Periodontal Regeneration

NCT06252935 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-09

No results posted yet for this study

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.

Conditions

  • Guided Tissue Regeneration
  • Collagen Membrane
  • Dental Diseases

Interventions

DEVICE

FormaAid

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.

DEVICE

Bio-Gide

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.

Sponsors & Collaborators

  • Tri-Service General Hospital

    collaborator OTHER

  • Maxigen Biotech Inc.

    lead INDUSTRY

Principal Investigators

  • Cheng-En Sung, Doctor · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2025-04-30
Completion
2025-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06252935 on ClinicalTrials.gov