Status:

NOT_YET_RECRUITING

RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)

Lead Sponsor:

Hyundai Bioland Co., Ltd.

Conditions:

Guided Bone Regeneration

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inc...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (among others):
  • Patients over 18 years old (both sex) with full legal capacity who understand the treatment and sign the informed consent and who are medically healthy, except treated condition.
  • Exclusion Criteria (among others):
  • Patients with dental diseases or conditions (except treated condition);
  • Patients with unsatisfactory oral hygiene;
  • Patients with alcohol, substance abuse, smoking habits, known allergy to collagen;
  • Patients with severe or chronic diseases or with systemic inflammation and all patients classified as unhealthy;
  • Pregnant or breast feeding women.

Exclusion

    Key Trial Info

    Start Date :

    December 16 2024

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 30 2026

    Estimated Enrollment :

    50 Patients enrolled

    Trial Details

    Trial ID

    NCT06570265

    Start Date

    December 16 2024

    End Date

    June 30 2026

    Last Update

    August 26 2024

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