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

Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Guided Bone Regeneration
• Intervention / Treatment: Device: GBR membrane

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pure Clinical; Phone Number: + 48; Email: MDsafety@pureclinical.eu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm	Device: GBR membrane; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Complication rate assessed as the ratio patients with any complication to all patients.	7 days and 6 months after intervention
Change in bone dimensions	% change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.	Baseline, 6 and 12 months after intervention
VAS scale	Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention.	On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.
Assessment of collagen membrane's - safety.	Number of (S)AEs.	From the beginning till the end.

Collaborators and Investigators

• Sponsor: Hyundai Bioland Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 16, 2024
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 19, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PC-MD-CIP-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No