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

Hyundai Bioland

Status: Not yet enrolling

Conditions: Guided Bone Regeneration

Treatments: Device: GBR membrane

Study type: Interventional

Funder types: Industry

Identifiers

NCT06570265

PC-MD-CIP-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Interventional arm

Experimental group

Treatment:

Device: GBR membrane