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In Vivo Investigation of 6 Membranes Including Their Physical, Chemical and Biological Properties.

NCT05443776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-05

No results posted yet for this study

Summary

A wide range of resorbable and non-resorbable membranes have been investigated over the last decades. Barrier membranes protect bone defects from ingrowth of soft tissue cells, provide mechanical stability of the defect area and allow bone progenitor cells to develop within a blood clot that is formed beneath the barrier membrane, taking a minimum of four to six weeks for periodontal tissues and 16-24 weeks for bone1,2.These membranes are utilized to reconstruct bone defects prior to implantation and to cover dehiscences and fenestrations around dental implants.

When aiming to regenerate bone, resorbable or a non - resorbable membranes should be selected depending on location, size and defect area. However, until now the ideal membrane has not been described due to different opinions between authors3,4. Nevertheless, an ideal membrane should maintain its barrier function enough time for new bone formation, and if possible should be resorbable, so that a second surgical procedure for the explantation of the membrane would not be required, thus reducing the morbidity5. However, the use of a barrier membrane is a technique-sensitive procedure that is not free of complications. The main cause of Guided Bone Regeneration (GBR) failure is related to early or late exposure of the membrane, leading to contamination and infection of the biomaterial, irreversibly compromising bone regeneration4,6,7. Consequently, the inflammatory reaction of the surrounding soft tissues may require early removal of the membrane. Other complications, such as the onset of an abscess with purulent exudate, can also lead to a complete failure of GBR even without exposure of the membrane.

It is thought necessary to perform this clinical study due to the lack of information present in the literature about the different types of membranes that exist nowadays, how they act in the human body with or without performing some type of regeneration and how our body acts towards them.

Conditions

  • Bone Regeneration
  • Tissue Engineering

Interventions

OTHER

Biomaterial implantation

Implant a approved biomaterial by European Regulatory Agencies

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • Jordi Caball, DDS MSc PhD · UIC Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2021-07-30
Completion
2022-03-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05443776 on ClinicalTrials.gov