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NCT Number: NCT05443776

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

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.

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Key information

Conditions

Bone Regeneration Tissue Engineering

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UIC Barcelona

Barcelona, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Biomaterial implantation

Other

Implant a approved biomaterial by European Regulatory Agencies

Primary outcomes

  1. Grade of the biocompatibility of the biomaterials

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

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

  2. Characteristics of the inmune response of the biomaterials in the host tissues

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

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

  3. Rate of degradation of the biomaterials

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

    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.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Official study title

In Vivo Investigation of Six Different Membranes Including Their Physical, Chemical and Biological Properties - a Pilot Study.

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jul 5, 2022
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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