Guided Bone Regeneration
Conditions
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.
Interventions
DEVICEGBR 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.
Sponsors
Hyundai Bioland Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Complication rate | 7 days and 6 months after intervention | Complication rate assessed as the ratio patients with any complication to all patients. |
| Change in bone dimensions | Baseline, 6 and 12 months after intervention | % change in horizontal bone dimensions at three subcrestal levels assessed via CBCT. |
| 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. |
| Assessment of collagen membrane's - safety. | From the beginning till the end. | Number of (S)AEs. |
Contacts
Primary ContactPure Clinical
Outcome results
None listed