Bone ResorptionNCT04480073
Guided Bone Regeneration With Customized Titanium Meshes
A study testing Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges in people with Bone Resorption, run by University of Milan at 1 site in Italy.
Trial summary
The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed… Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2018to 30 Dec 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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- systemically healthy patients;
- a minimum age of 18 years;
- relevant or severe bone atrophy at the edentulous sites incompatible with placement of even short (≤6 mm) or narrow (<3 mm) implants in an appropriate and prosthetically guided position;
- adequate compliance of patients, both in terms of oral hygiene and respect the follow-up recalls;
- ability to understand the proposed surgical treatment and to understand and sign the informed consent.
Who cannot join
- severe kidney and/or liver disease;
- congenital or acquired immunodeficiency;
- ongoing antiblastic chemotherapy at the time of first examination;
- sequelae of radiotherapy in the head and neck area;
- oral mucosa diseases, such as lichen planus;
- full mouth plaque score (FMPS) and full mouth bleeding score (FMBS) < 20%;
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- non-compliant patients;
- tobacco abuse (>10 cigarettes per day) or alcohol abuse;
- non compensated diabetes;
- active periodontal disease at the time of first examination ;
- bisphosphonate chemotherapy in progress;
- pregnant women.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ASST Santi Paolo e Carlo
Milan, 20142
Matteo Chiapasco, Professor, matteo.chiapasco@unimi.it
About this study
Official title: Customized CAD/CAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects: Preliminary Results of a Prospective Clinical Follow-up Study in Humans
The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view
Read the detailed description
Objectives:
- to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body and/or ramus mixed with bovine bone mineral bone granules (500-1000microns in diameter):
- complication rate of the reconstructive procedure;
- assessment of bone gain obtained before implant placement;
- implant survival and implant-related complications 1 year after the starting of prosthetic loading;
- peri-implant bone resorption (MBL) after 1 year from the prosthetic load.
- to perform a histomorphometric analysis of bone samples taken from sites reconstructed according to the principle of Guided Bone regeneration by means of autologous bone chips mixed with a xenograft with a 1:1 ratio and customized titanium mesh.
The following parameters will be analyzed from an histologic point of view:
- bone remodeling and mineralization levels of the new bone matrix
- volumetric tissue fractions
- neo-vascularization
Study method: prospective study - 24 consecutive patients treated (see statistical power analysis)
The study will be performed in accordance with the ISO Standard 14155: 2011, Clinical Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the Medical Device Directive 93/42/ EEC and following the 2004 Helsinki Declaration.
The null hypothesis (H0) is the following: the reconstructed bone is not functionally mature to support implants, masticatory and functional loads after 12 months.
The sample size calculation was performed with the statistical program https://clincalc.com/stats/samplesize.aspx. A literature search on PubMed was performed and revealed that, on average, the percentage of new bone formed after reconstructions with particulate bone autografts and xenografts and titanium mesh is 66% with a standard deviation of 6%. The expected percentage value for the investigator's study was set at 70% with a statistical power of 90% and a two-tier significance level of 0.05.
Data distribution will be analyzed by Shapiro Wilk's normality test, due to the small sample size.
If the data distribution is normal, the comparative analysis for the primary outcome will be performed by T-student test for paired samples. If the data distribution is not normal, a Wilcoxon test will be performed.
The independent variable of the study is the bone reconstruction procedure. The dependent variables are: a) the histomorphometric values of the reconstructed bone; b) the increase (measured in mm) of the bone reconstruction obtained; c) the MBL (in mm) peri-implant 1 year after the prosthetic load.
Data analysis will be performed with SPSS software. Differences will be considered statistically significant for alpha <0.05.
- Conditions
- Bone Resorption
- Being tested
- Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges
- Keywords
- guided bone regeneration, dental implants, alveolar bone defects, custom-made, Titanium mesh, CAD-CAM, implant-supported prosthesis, autogenous bone
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridgesProcedure or surgery
Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws.
A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls.
6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement.
Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement.
3 months later, implants will be uncovered and the prosthetic phases will start.
Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications.
| Study group | Role | What they receive |
|---|---|---|
| edentulous patients with atrophic jaws | Other | patients presenting with severely atrophic edentulous sites in the upper and lower jaw, and requesting implant-supported prosthetic restorations, will be enrolled in this study. Receives: Procedure: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
Samples will be processed following a standardized protocol for hard tissues.
Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Measured: 6-9 months
Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions
Samples will be processed following a standardized protocol for hard tissues.
Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Measured: 6-9 months
Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization
Samples will be processed following a standardized protocol for hard tissues.
Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Measured: 6-9 months
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure
Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed
Measured: 6-9 months
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain
Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed
Measured: 6-9 months
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival
Implant survival (expressed in percentage) will be analyzed
Measured: 12 months
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications
Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed
Measured: 12 months
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption
Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start10 Jan 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Matto Chiapasco, University of Milan
- Investigators
- Matteo Chiapasco, Professor, Principal investigator, Department of Biomedical, Surgical and Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480073
- Sponsor's protocol ID
- MChiapasco
- Status last verified
- Jul 2020
- First submitted
- 4 Jul 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: collecting data to verify the effectiveness of bone regeneration with customized titanium meshes and publication of results on peer-reviewed international journals
Publications
Sagheb K, Schiegnitz E, Moergel M, Walter C, Al-Nawas B, Wagner W. Clinical outcome of alveolar ridge augmentation with individualized CAD-CAM-produced titanium mesh. Int J Implant Dent. 2017 Dec;3(1):36. doi: 10.1186/s40729-017-0097-z. Epub 2017 Jul 26.
PubMed 28748521Seiler M, Kammerer PW, Peetz M, Hartmann A. Customized lattice structure in reconstruction of three-dimensional alveolar defects. Int J Comput Dent. 2018;21(3):261-267.
PubMed 30264055Sumida T, Otawa N, Kamata YU, Kamakura S, Mtsushita T, Kitagaki H, Mori S, Sasaki K, Fujibayashi S, Takemoto M, Yamaguchi A, Sohmura T, Nakamura T, Mori Y. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh. J Craniomaxillofac Surg. 2015 Dec;43(10):2183-8. doi: 10.1016/j.jcms.2015.10.020. Epub 2015 Oct 23.
PubMed 26603108
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customized CAD/CAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects: Preliminary Results of a Prospective Clinical Follow-up Study in Humans
- ClinicalTrials.gov ID
- NCT04480073
- Acronym / sponsor ID
- MChiapasco
- Conditions
- Bone Resorption
- Keywords
- guided bone regeneration, dental implants, alveolar bone defects, custom-made, Titanium mesh, CAD-CAM, implant-supported prosthesis, autogenous bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 Jul 2020 (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 aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view
Detailed description
Objectives:
- to evaluate the effectiveness of digitally customized titanium meshes for guided bone regeneration with autologous bone chips taken from the mandibular body and/or ramus mixed with bovine bone mineral bone granules (500-1000microns in diameter):
- complication rate of the reconstructive procedure;
- assessment of bone gain obtained before implant placement;
- implant survival and implant-related complications 1 year after the starting of prosthetic loading;
- peri-implant bone resorption (MBL) after 1 year from the prosthetic load.
- to perform a histomorphometric analysis of bone samples taken from sites reconstructed according to the principle of Guided Bone regeneration by means of autologous bone chips mixed with a xenograft with a 1:1 ratio and customized titanium mesh.
The following parameters will be analyzed from an histologic point of view:
- bone remodeling and mineralization levels of the new bone matrix
- volumetric tissue fractions
- neo-vascularization
Study method: prospective study - 24 consecutive patients treated (see statistical power analysis)
The study will be performed in accordance with the ISO Standard 14155: 2011, Clinical Investigation of Medical Devices for Human Patients with the Appendices VIII and X of the Medical Device Directive 93/42/ EEC and following the 2004 Helsinki Declaration.
The null hypothesis (H0) is the following: the reconstructed bone is not functionally mature to support implants, masticatory and functional loads after 12 months.
The sample size calculation was performed with the statistical program https://clincalc.com/stats/samplesize.aspx. A literature search on PubMed was performed and revealed that, on average, the percentage of new bone formed after reconstructions with particulate bone autografts and xenografts and titanium mesh is 66% with a standard deviation of 6%. The expected percentage value for the investigator's study was set at 70% with a statistical power of 90% and a two-tier significance level of 0.05.
Data distribution will be analyzed by Shapiro Wilk's normality test, due to the small sample size.
If the data distribution is normal, the comparative analysis for the primary outcome will be performed by T-student test for paired samples. If the data distribution is not normal, a Wilcoxon test will be performed.
The independent variable of the study is the bone reconstruction procedure. The dependent variables are: a) the histomorphometric values of the reconstructed bone; b) the increase (measured in mm) of the bone reconstruction obtained; c) the MBL (in mm) peri-implant 1 year after the prosthetic load.
Data analysis will be performed with SPSS software. Differences will be considered statistically significant for alpha <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| edentulous patients with atrophic jaws | Other | Procedure: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridgespatients presenting with severely atrophic edentulous sites in the upper and lower jaw, and requesting implant-supported prosthetic restorations, will be enrolled in this study. |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- systemically healthy patients;
- a minimum age of 18 years;
- relevant or severe bone atrophy at the edentulous sites incompatible with placement of even short (≤6 mm) or narrow (<3 mm) implants in an appropriate and prosthetically guided position;
- adequate compliance of patients, both in terms of oral hygiene and respect the follow-up recalls;
- ability to understand the proposed surgical treatment and to understand and sign the informed consent.
Key exclusion criteria (12 listed)
- severe kidney and/or liver disease;
- congenital or acquired immunodeficiency;
- ongoing antiblastic chemotherapy at the time of first examination;
- sequelae of radiotherapy in the head and neck area;
- oral mucosa diseases, such as lichen planus;
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 |
|---|---|---|
| Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridgesStep one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws. A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls. 6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement. Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement. 3 months later, implants will be uncovered and the prosthetic phases will start. Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications. | Procedure or surgery | edentulous patients with atrophic jaws |
Primary outcome
Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels
Time frame: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions
Time frame: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization
Time frame: 6-9 months
Samples will be processed following a standardized protocol for hard tissues. Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure
Time frame: 6-9 months
Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain
Time frame: 6-9 months
Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival
Time frame: 12 months
Implant survival (expressed in percentage) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications
Time frame: 12 months
Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed
Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption
Time frame: 6-9 months
Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Results publication: PubMed 28748521Sagheb K, Schiegnitz E, Moergel M, Walter C, Al-Nawas B, Wagner W. Clinical outcome of alveolar ridge augmentation with individualized CAD-CAM-produced titanium mesh. Int J Implant Dent. 2017 Dec;3(1):36. doi: 10.1186/s40729-017-0097-z. Epub 2017 Jul 26.
- Results publication: PubMed 30264055Seiler M, Kammerer PW, Peetz M, Hartmann A. Customized lattice structure in reconstruction of three-dimensional alveolar defects. Int J Comput Dent. 2018;21(3):261-267.
- Results publication: PubMed 26603108Sumida T, Otawa N, Kamata YU, Kamakura S, Mtsushita T, Kitagaki H, Mori S, Sasaki K, Fujibayashi S, Takemoto M, Yamaguchi A, Sohmura T, Nakamura T, Mori Y. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh. J Craniomaxillofac Surg. 2015 Dec;43(10):2183-8. doi: 10.1016/j.jcms.2015.10.020. Epub 2015 Oct 23.
- Individual participant dataSharing planned: No. collecting data to verify the effectiveness of bone regeneration with customized titanium meshes and publication of results on peer-reviewed international journals
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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.
Matteo Chiapasco, Professor principal investigator
Department of Biomedical, Surgical and Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges in people with Bone Resorption, run by University of Milan at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Jul 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matteo Chiapasco, Professor (+390250319000, matteo.chiapasco@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels (time frame: 6-9 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480073, which also lists 3 linked publications.
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 21 Jul 2020.