Bone ResorptionBICNCT06226116
COMPARATIVE STUDY OF BONE IMPLANT CONTACT (BIC) ON NEW BONE REGENERATED WITH AUTOGENOUS DENTIN AND NATIVE BONE
A study testing socket preservation, placement of experimental implants and histological sample collection in people with Bone Resorption and Bone Regeneration, run by Universidad de León at 1 site in Spain.
Trial summary
The healing process after tooth removal involves bone remodelling which implies some loss of alveolar bone volume.Among materials proposed for minimising this remodelling and preserving the bone, autologous dental tissue is a promising option, but more data are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Resorption, Bone Regeneration
- What is being tested?
- socket preservation, placement of experimental implants and histological sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 1 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially or totally edentulous patients for whom treatment is indicated
- At least 18 years of age, of both sexes and of any race.
- That they understand that they are involved in the study, including the visit requirements of follow-up.
- With 6 mm. or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm. of length. After 16 weeks Explantation will be performed for the study, followed by placement of a wider implant.
Who cannot join
- Smokers.
- Pregnancy.
- History of uncontrolled systemic disease or chronic diseases.
- Coagulation disorder or taking anticoagulants.
- Treatment with bisphosphonates.
- Subjects with severe compromise of the immune system.
- History of mental instability that hinders participation in the study.
- Other conditions that the investigator may feel the patient is not a good candidate for this study (e.g., alcoholism, drug addiction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Bone Implant Contact (BIC) With Experimental Bioecth® Surface Implant Between Native Bone and Regenerated Bone With Autogenous Dentine.
The healing process after tooth removal involves bone remodelling which implies some loss of alveolar bone volume.Among materials proposed for minimising this remodelling and preserving the bone, autologous dental tissue is a promising option, but more data are needed. In this context, the investigator evaluated size and density changes using cone beam computed tomography in autologous dental material (ADM)-preserved sockets compared to controls,and assessed biological responses by histological analysis of bone implant contact (BIC) an Area density (AA) using experimental Bioetch® surface implant.
Read the detailed description
30 patients will be selected for the study, based on the inclusion/exclusion criteria and the clinical judgment of the investigator. Prior to enrollment, all subjects will be asked sign an informed consent form to demonstrate that the patient understand the scope of the study (including surgical interventions and the potential risks involved), allowing the opportunity to ask questions related to the study and giving information about treatments alternatives.
Inclusion criteria:
Partially or totally edentulous patients for whom treatment is indicated. At least 18 years of age, of both sexes and of any race. That the the participants understand that are involved in the study, including the visit requirements of follow-up.
With 6 mm or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm of length. After 16 weeks explantation will be performed for the study, followed by placement of a wider implant.
Exclusion criteria:
Smokers. Pregnancy. History of uncontrolled systemic disease or chronic diseases. Coagulation disorder or taking anticoagulants. Treatment with bisphosphonates. Subjects with severe compromise of the immune system. History of mental instability that hinders participation in the study. Other conditions that the investigator may feel the patient is not a good candidate for this study (e.g., alcoholism, drug addiction).
Implant material: 2 mm diameter and 8 mm. of length cylinders will be used in the study. The body will be threaded with a pitch of 0.25mm. and with Bioetch® subtraction surface. The cylinders will be placed after the passage of the milling cutter. Lance and the 1.8 mm diameter. The implant enters the bed because its head It is machined with a knurled key figure that adjusts the universal screwdriver.
After 16 weeks, the study cylinders will be explanted with a trephine drill. Internal diameter 4 mm and external 4.5 mm which, in most cases, ensures recovery of the cylinder with osseointegrated material around it along its entire length.
Next, the trephine bur, with the material inside, is placed in formaldehyde buffered at 10% for transfer to the laboratory.
The patient will receive a 5 mm implant. in diameter, to rehabilitate the area where it has been collected the sample.
3 - Histological methodology: The collected sample will be placed in buffered formalin and then sent to the Histology laboratory, Anatomy section of the Department of Surgery, Medical Sciences and Social Services of the University of Alcala, for processing. This will be done in the following way:
- Inclusion of the sample in plastic polymers of tissue section.
- Histological preparations with undecalcified bone sections and with the implant included.
- Cutting the samples with the EXACT system. Histological study of the sections with the description and differentiation of bone tissue in each sample.
- Staining of the sections with toluidine blue, hematoxylin-eosin and/or trichrome.
- Evaluation of the presence or absence of inflammatory reaction or foreign body reaction.
- Histomorphometric study of the sample based on the morphology of the surface of the implant. The sample will be evaluated with the MIP-4 program evaluating the percentage of osseointegration (BIC), taking into account the area around the implant.
- Statistical study to evaluate differences between the two types of samples with test analysis of variance (ANOVA).
- Conditions
- Bone Resorption, Bone Regeneration
- Being tested
- socket preservation, placement of experimental implants, histological sample collection
- Keywords
- bone implant contact, autologous dentin, socket preservation, bone density area
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket preservationProcedure or surgery
After the tooth extraction the investigator will select two sockets, one will be assigned as the experimental side and we will preserve it with cold-processed autologous dentin. The second will be designated the control group and we will only stabilize the blood clot.
placement of experimental implantsProcedure or surgery
After four months of preservation, titanium cylinders measuring 2 mm wide by 8 mm long, with a Bioetch® surface, will be placed.
histological sample collectionProcedure or surgery
Biopsy with trephine of a bone portion of 4mm in diameter and 10mm in length, which includes the titanium cylinder inside.
Placement of conventional implant 5mm wide by 10mm long.
| Study group | Role | What they receive |
|---|---|---|
| socket preservation with autologous dentin | Experimental | Not described Receives: Procedure: socket preservation; Procedure: placement of experimental implants; Procedure: histological sample collection |
| extract teeth socket | Placebo comparator | only stabilized blood clot Receives: Procedure: placement of experimental implants; Procedure: histological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIC
Histomorphometric study of the sample based on the morphology of the surface of the implant. The sample will be evaluated with the MIP-4 program evaluating the percentage of osseointegration (BIC), taking into account the area around the implant.
Measured: 16 weeks after implant placement
AA Bone density area
evaluation of bone density in 0.25 mm around the experimental implant using the MIP-4 program
Measured: 16 weeks after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Jan 2018
- Primary completion1 Aug 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hernán López Sacristán, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226116
- Sponsor's protocol ID
- ULE-034-2018
- Acronym
- BIC
- Status last verified
- Jan 2024
- First submitted
- 20 Dec 2023
- Last updated
- 26 Jan 2024
- 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 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Bone Implant Contact (BIC) With Experimental Bioecth® Surface Implant Between Native Bone and Regenerated Bone With Autogenous Dentine.
- ClinicalTrials.gov ID
- NCT06226116
- Acronym / sponsor ID
- BIC / ULE-034-2018
- Conditions
- Bone Resorption, Bone Regeneration
- Keywords
- bone implant contact, autologous dentin, socket preservation, bone density area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Jan 2024 (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.
The healing process after tooth removal involves bone remodelling which implies some loss of alveolar bone volume.Among materials proposed for minimising this remodelling and preserving the bone, autologous dental tissue is a promising option, but more data are needed. In this context, the investigator evaluated size and density changes using cone beam computed tomography in autologous dental material (ADM)-preserved sockets compared to controls,and assessed biological responses by histological analysis of bone implant contact (BIC) an Area density (AA) using experimental Bioetch® surface implant.
Detailed description
30 patients will be selected for the study, based on the inclusion/exclusion criteria and the clinical judgment of the investigator. Prior to enrollment, all subjects will be asked sign an informed consent form to demonstrate that the patient understand the scope of the study (including surgical interventions and the potential risks involved), allowing the opportunity to ask questions related to the study and giving information about treatments alternatives.
Inclusion criteria:
Partially or totally edentulous patients for whom treatment is indicated. At least 18 years of age, of both sexes and of any race. That the the participants understand that are involved in the study, including the visit requirements of follow-up.
With 6 mm or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm of length. After 16 weeks explantation will be performed for the study, followed by placement of a wider implant.
Exclusion criteria:
Smokers. Pregnancy. History of uncontrolled systemic disease or chronic diseases. Coagulation disorder or taking anticoagulants. Treatment with bisphosphonates. Subjects with severe compromise of the immune system. History of mental instability that hinders participation in the study. Other conditions that the investigator may feel the patient is not a good candidate for this study (e.g., alcoholism, drug addiction).
Implant material: 2 mm diameter and 8 mm. of length cylinders will be used in the study. The body will be threaded with a pitch of 0.25mm. and with Bioetch® subtraction surface. The cylinders will be placed after the passage of the milling cutter. Lance and the 1.8 mm diameter. The implant enters the bed because its head It is machined with a knurled key figure that adjusts the universal screwdriver.
After 16 weeks, the study cylinders will be explanted with a trephine drill. Internal diameter 4 mm and external 4.5 mm which, in most cases, ensures recovery of the cylinder with osseointegrated material around it along its entire length.
Next, the trephine bur, with the material inside, is placed in formaldehyde buffered at 10% for transfer to the laboratory.
The patient will receive a 5 mm implant. in diameter, to rehabilitate the area where it has been collected the sample.
3 - Histological methodology: The collected sample will be placed in buffered formalin and then sent to the Histology laboratory, Anatomy section of the Department of Surgery, Medical Sciences and Social Services of the University of Alcala, for processing. This will be done in the following way:
- Inclusion of the sample in plastic polymers of tissue section.
- Histological preparations with undecalcified bone sections and with the implant included.
- Cutting the samples with the EXACT system. Histological study of the sections with the description and differentiation of bone tissue in each sample.
- Staining of the sections with toluidine blue, hematoxylin-eosin and/or trichrome.
- Evaluation of the presence or absence of inflammatory reaction or foreign body reaction.
- Histomorphometric study of the sample based on the morphology of the surface of the implant. The sample will be evaluated with the MIP-4 program evaluating the percentage of osseointegration (BIC), taking into account the area around the implant.
- Statistical study to evaluate differences between the two types of samples with test analysis of variance (ANOVA).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| socket preservation with autologous dentin | Experimental | Procedure: socket preservation, Procedure: placement of experimental implants, Procedure: histological sample collection |
| extract teeth socket | Placebo comparator | Procedure: placement of experimental implants, Procedure: histological sample collectiononly stabilized blood clot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Partially or totally edentulous patients for whom treatment is indicated
- At least 18 years of age, of both sexes and of any race.
- That they understand that they are involved in the study, including the visit requirements of follow-up.
- With 6 mm. or more bone width, which will be sufficient to place a cylindrical implant with 2 mm Bioetch® surface. in diameter and 8 mm. of length. After 16 weeks Explantation will be performed for the study, followed by placement of a wider implant.
Key exclusion criteria (8 listed)
- Smokers.
- Pregnancy.
- History of uncontrolled systemic disease or chronic diseases.
- Coagulation disorder or taking anticoagulants.
- Treatment with bisphosphonates.
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 |
|---|---|---|
| socket preservationAfter the tooth extraction the investigator will select two sockets, one will be assigned as the experimental side and we will preserve it with cold-processed autologous dentin. The second will be designated the control group and we will only stabilize the blood clot. | Procedure or surgery | socket preservation with autologous dentin |
| placement of experimental implantsAfter four months of preservation, titanium cylinders measuring 2 mm wide by 8 mm long, with a Bioetch® surface, will be placed. | Procedure or surgery | extract teeth socket, socket preservation with autologous dentin |
| histological sample collectionBiopsy with trephine of a bone portion of 4mm in diameter and 10mm in length, which includes the titanium cylinder inside. Placement of conventional implant 5mm wide by 10mm long. | Procedure or surgery | extract teeth socket, socket preservation with autologous dentin |
Primary outcome
BIC
Time frame: 16 weeks after implant placement
Histomorphometric study of the sample based on the morphology of the surface of the implant. The sample will be evaluated with the MIP-4 program evaluating the percentage of osseointegration (BIC), taking into account the area around the implant.
AA Bone density area
Time frame: 16 weeks after implant placement
evaluation of bone density in 0.25 mm around the experimental implant using the MIP-4 program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socket preservation, placement of experimental implants and histological sample collection in people with Bone Resorption and Bone Regeneration, run by Universidad de León 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
BIC (time frame: 16 weeks after implant placement). The study lists 2 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 26 Jan 2024.