RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)
Not Applicable
Not yet recruiting
- Conditions
- Guided Bone Regeneration
- Interventions
- Device: GBR membrane
- Registration Number
- NCT06570265
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Interventional arm GBR membrane -
- Primary Outcome Measures
Name Time Method Assessment of collagen membrane's - efficacy and safety. 6 months after intervention Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.
- Secondary Outcome Measures
Name Time Method Change in bone dimensions Baseline, 6 and 12 months after intervention % change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.
Assessment of collagen membrane's - safety. From the beginning till the end. Number of (S)AEs.
Complication rate 7 days and 6 months after intervention Complication rate assessed as the ratio patients with any complication to all patients.
VAS scale On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention. Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention.