Health TrialsbyHealthPanel

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

ConditionGuided Bone Regeneration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHyundai Bioland Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Interventional armExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months after intervention

Secondary outcomes

1

Complication rate

Complication rate assessed as the ratio patients with any complication to all patients.

Time frame
7 days and 6 months after intervention
2

Change in bone dimensions

% change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.

Time frame
Baseline, 6 and 12 months after intervention
3

VAS scale

Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention.

Time frame
On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.
4

Assessment of collagen membrane's - safety.

Number of (S)AEs.

Time frame
From the beginning till the end.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hyundai Bioland Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: