Menu
Not yet recruiting NCT06570265

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

No phase Interventional Guided Bone Regeneration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GBR membrane.
Who it may be relevant to
Registry conditions: Guided Bone Regeneration. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Assessment of collagen membrane's - efficacy and safety. [Time frame: 6 months after intervention]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06570265 · PC-MD-CIP-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗