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NCT06570265 | NOT YET RECRUITING | Guided Bone Regeneration

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

Hyundai Bioland Co., Ltd.

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 inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.

Condition or disease

Guided Bone Regeneration

Intervention/treatment

GBR membrane

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.
Actual Study Start Date : 2024-12-16
Estimated Primary Completion Date : 2026-05-16
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)

Location Details

NCT06570265

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

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