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

NCT05443776 | Completed

• 1 other identifier: CIR-ECL-2018-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Grade of the biocompatibility of the biomaterials

  The grade of biocompatibility will be assessed by using histology tools, analyzing the type of cells present in the sample.

  Outcome will be measured once, after samples are collected and processed, 2-3 months after implantation.

• Characteristics of the inmune response of the biomaterials in the host tissues

  The characteristics of the inmune response will be assessed by using histology tools, determining the presence of inflammatory cells such as macrophages.

  Outcome will be measured once, after samples are collected and processed, 2-3 months after implantation.

• Rate of degradation of the biomaterials

  The rate of degradation of the biomaterials will be assessed by using histology tools, analyzing the amount of biomaterial present in the samples and comparing it to the amount that was implanted.

  Outcome will be measured once, after samples are collected and processed, 2-3 months after implantation.

Study Arms (6)

Study group biomaterial 1

EXPERIMENTAL

Other: Biomaterial implantation

Study group biomaterial 2

EXPERIMENTAL

Other: Biomaterial implantation

Study group biomaterial 3

EXPERIMENTAL

Other: Biomaterial implantation

Study group biomaterial 4

EXPERIMENTAL

Other: Biomaterial implantation

Study group biomaterial 5

EXPERIMENTAL

Other: Biomaterial implantation

Study group biomaterial 6

EXPERIMENTAL

Other: Biomaterial implantation

Interventions

Biomaterial implantation OTHER

Implant a approved biomaterial by European Regulatory Agencies

Study group biomaterial 1; Study group biomaterial 2; Study group biomaterial 3; Study group biomaterial 4; Study group biomaterial 5; Study group biomaterial 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

UIC Barcelona

Barcelona, Spain

Location

Study Officials

• Jordi Caball, DDS MSc PhD

  UIC Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 6 different. products used, each compared between each other

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: July 5, 2022
• Study Start: September 15, 2019
• Primary Completion: July 30, 2021
• Study Completion: March 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)