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

NCT06570265 | Not Yet Recruiting

• 1 other identifier: PC-MD-CIP-001
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Guided Bone Regeneration

Outcome Measures

Primary Outcomes (1)

• Assessment of collagen membrane's - efficacy and safety.

  Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.

  6 months after intervention

Secondary Outcomes (4)

• Complication rate

  7 days and 6 months after intervention

• Change in bone dimensions

  Baseline, 6 and 12 months after intervention

• VAS scale

  On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.

• Assessment of collagen membrane's - safety.

  From the beginning till the end.

Study Arms (1)

Interventional arm

EXPERIMENTAL

Device: GBR membrane

Interventions

GBR membrane DEVICE

GBR procedure is a technique often used in conjunction with dental implants to enhance the success and stability of the implant. This technique involves using barrier membranes to protect the bone graft or defect site from the rapid proliferation of surrounding soft tissues. In this clinical investigation resorbable, collagen membrane will be used.

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyundai Bioland Co., Ltd.: lead

Central Study Contacts

Pure Clinical

CONTACT

+ 48; MDsafety@pureclinical.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 26, 2024

Record last verified: 2024-08