Guided Bone RegenerationNCT06570265
RES-SAFE (Resorption, Safety, and Efficacy of Absorbable Collagen Membrane)
A study testing GBR membrane in people with Guided Bone Regeneration, run by Hyundai Bioland Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- GBR membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Guided Bone Regeneration
- Being tested
- GBR membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR membraneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Not described Receives: Device: GBR membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after intervention
Secondary outcomes (4)
Complication rate
Complication rate assessed as the ratio patients with any complication to all patients.
Measured: 7 days and 6 months after intervention
Change in bone dimensions
% change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.
Measured: 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.
Measured: 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.
Measured: From the beginning till the end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start16 Dec 2024 (estimated)
- Primary completion16 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hyundai Bioland Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570265
- Sponsor's protocol ID
- PC-MD-CIP-001
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Resorption, Safety, and Efficacy of Absorbable Collagen Membrane in Preventing Significant Bone Loss Following GBR (Guided Bone Regeneration) Procedure.
- ClinicalTrials.gov ID
- NCT06570265
- Acronym / sponsor ID
- PC-MD-CIP-001
- Conditions
- Guided Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hyundai Bioland Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (estimated)
- Primary completion
- 16 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: GBR membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBR membraneGBR 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. | Device | Interventional arm |
Primary outcome
Assessment of collagen membrane's - efficacy and safety.
Time frame: 6 months after intervention
Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.
4 secondary outcomes
Complication rate
Time frame: 7 days and 6 months after intervention
Change in bone dimensions
Time frame: Baseline, 6 and 12 months after intervention
VAS scale
Time frame: On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.
Assessment of collagen membrane's - safety.
Time frame: From the beginning till the end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing GBR membrane in people with Guided Bone Regeneration, run by Hyundai Bioland Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pure Clinical (+ 48, MDsafety@pureclinical.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of collagen membrane's - efficacy and safety. (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.