Bone RegenerationNCT05443776
In Vivo Investigation of 6 Membranes Including Their Physical, Chemical and Biological Properties.
A study testing Biomaterial implantation in people with Bone Regeneration and Tissue Engineering, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration, Tissue Engineering
- What is being tested?
- Biomaterial implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2019to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: In Vivo Investigation of Six Different Membranes Including Their Physical, Chemical and Biological Properties - a Pilot Study.
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
- Being tested
- Biomaterial implantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomaterial implantationOther
Implant a approved biomaterial by European Regulatory Agencies
| Study group | Role | What they receive |
|---|---|---|
| Study group biomaterial 1 | Experimental | Not described Receives: Other: Biomaterial implantation |
| Study group biomaterial 2 | Experimental | Not described Receives: Other: Biomaterial implantation |
| Study group biomaterial 3 | Experimental | Not described Receives: Other: Biomaterial implantation |
| Study group biomaterial 4 | Experimental | Not described Receives: Other: Biomaterial implantation |
| Study group biomaterial 5 | Experimental | Not described Receives: Other: Biomaterial implantation |
| Study group biomaterial 6 | Experimental | Not described Receives: Other: Biomaterial implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Outcome will be measured once, after samples are collected and processed, 2-3 months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start15 Sep 2019
- Primary completion30 Jul 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 6 different. products used, each compared between each other
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi caballé, Universitat Internacional de Catalunya
- Investigators
- Jordi Caball, DDS MSc PhD, Principal investigator, UIC Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443776
- Sponsor's protocol ID
- CIR-ECL-2018-03
- Status last verified
- Jun 2022
- First submitted
- 18 Mar 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Investigation of Six Different Membranes Including Their Physical, Chemical and Biological Properties - a Pilot Study.
- ClinicalTrials.gov ID
- NCT05443776
- Acronym / sponsor ID
- CIR-ECL-2018-03
- Conditions
- Bone Regeneration, Tissue Engineering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 5 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- Model description
- 6 different. products used, each compared between each other
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomaterial implantationImplant a approved biomaterial by European Regulatory Agencies | Other | Study group biomaterial 1, Study group biomaterial 2, Study group biomaterial 3, Study group biomaterial 4, Study group biomaterial 5, Study group biomaterial 6 |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Caball, DDS MSc PhD principal investigator
UIC Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomaterial implantation in people with Bone Regeneration and Tissue Engineering, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.