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

NCT ID: NCT05443776

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2022-03-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Study group biomaterial 1

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 2

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 3

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 4

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 5

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 6

Group Type: EXPERIMENTAL

Biomaterial implantation

Intervention Type: OTHER

Implant a approved biomaterial by European Regulatory Agencies

Interventions

Biomaterial implantation

Implant a approved biomaterial by European Regulatory Agencies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Overall, healthy patients that qualify for oral surgery (ASA I and II)
• Older than 18 years old
• Requiring extraction of 1-3 teeth (premolars or molars) that do not involve the aesthetic area
• Stable post-extraction socket walls with at least 4 walls
• Patient candidate to an early implant placement in the extraction area
• Informed consent signed
• Adequate oral hygiene: plaque index < 25% before the surgery
• Smoker of <10 cigarettes per day
• Able to follow the instructions and able to meet the follow-ups
• Healthy or controlled periodontal disease

Exclusion Criteria

• Patients who not agree with informed consent
• Untreated periodontal disease
• Presence of dehiscence and/or fenestration at buccal plate of the extraction teeth
• Patient who will need GBR or Block Regeneration
• after the extraction
• History of head and/or neck radiation
• History of chemotherapy in the five years prior of the surgery
• Non controlled Diabetes
• Chronic corticoids or other medication that may influence healing and / or osseointegration
• Smoker of >10 cigars per day
• Alcohol or other drugs abuse
• Patient going under bisphosphonates treatment or taking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Internacional de Catalunya

OTHER

Sponsor Role: lead

Responsible Party

Jordi caballé

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordi Caball, DDS MSc PhD

Role: PRINCIPAL_INVESTIGATOR

UIC Barcelona

Locations

UIC Barcelona

Barcelona, , Spain

Countries

Spain

Other Identifiers

CIR-ECL-2018-03

Identifier Type: -

Identifier Source: org_study_id