Alveolar Bone ResorptionNCT05937035
Histological and Volumetric Evaluation of Customized Allograft Bone Blocks
A study testing Customized allogenic bone block surgery in people with Alveolar Bone Resorption and Graft Overgrowth, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Graft Overgrowth, Resorption of Bone Graft
- What is being tested?
- Customized allogenic bone block surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 25 May 2024to 25 Jul 2025
- 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
- Signed informed consent
- Overall, healthy subjects (ASA1 and 2)
- Females and males of at least eighteen-years
- Requiring a posterior mandible rehabilitation with a minimum of 2 dental implants
- Able to follow instructions and attend a regular compliance
Who cannot join
- Acute local infection
- Untreated periodontal disease assessed by Socransky et al. parameters (≥ 2mm clinical attachment loss in two consecutive visits within 1 year)
- Drug and/or alcoholic dependencies
- Medical conditions contraindicating implant surgery
- History of head and/or neck radiation
- Bisphosphonate therapy
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Iñigo Arévalo Lázaro, DDS, MSc, +34688692201, arevaloinigo@gmail.com
Javier Gamón Vidal, +34627321249
About this study
Official title: Histological and Volumetric Evaluation of Customized Allograft Bone Blocks in Severe Atrophy of the Mandible: a Prospective Cohort Clinical Trial
Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications.
Objectives: The primary aim of this study is to determine the bone regeneration capacity through a histological study and the bone volumetric changes of allograft bone blocks in the posterior site of the mandible. The secondary outcome will be to assess the survival and success rate of dental implants placed in the allograft regenerated area.
Materials and Methods: After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.
Read the detailed description
Allogenic bone blocks are a great bone regeneration technique option comparing to autologous regeneration treatments. There are several techniques of vertical guided bone regeneration but also have a large number of complications and failures. Some of the advantages of Customized Allograft Bone Blocks are: less invasive, causes less morbidity and resorption of the recipient site. Non resorbable membranes with particulate grafting material and autologous bone blocks are technically demanding and difficult to achieve stability to create new bone. Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. It is important to place the implants in an ideal prosthetic position to achieve excellent long-term results. Implant supported prosthesis can be contraindicated because of the lack of bone. Looking in to the classification of CAWOOD and HOWEL type 5 bone need bone augmentation techniques. In some cases, increasing the difficulty with the superficialization of the alveolar nerve. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications. The use of autogenous bone increases the risk of damaging anatomical structures increasing the morbidity, however thanks to allograft the investigators can avoid these problems. There are many different types of allografts, fresh-frozen bone (FFBA), freeze-dried bone (FDBA), demineralised freeze-dried bone allograft (DFDBA) and mineralised processed bone (MPBA). The allograft used for this study is a cellular cancellous bone material mechanically and chemically processed and sterilised by irradiation. This allogenic biomaterial has an osteoconductive property which facilitates the cell migration and proliferation for neoformation.
Study design A prospective controlled clinical trial will be conducted.
Residents of the International Master in Oral Surgery will perform the surgical and prosthodontic final rehabilitation procedures. All the included patients will sign an appropriate inform prior to any study-related actions. Firstly, an intraoral digital impression with intraoral scanner will be taken and a diagnostic wax-up will be performed. Subsequently, a cone-beam computed tomography scan would be taken in the specific area to be treated. After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. Releasing incisions will be performed to achieve the correct closure of the flap. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, photographs, periapical xrays digital impressions and 2nd CBCT will be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.
- Conditions
- Alveolar Bone Resorption, Graft Overgrowth, Resorption of Bone Graft, Graft Complication, Block
- Being tested
- Customized allogenic bone block surgery
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized allogenic bone block surgeryProcedure or surgery
After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. Releasing incisions will be performed to achieve the correct closure of the flap. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, photographs, periapical xrays digital impressions and 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.
| Study group | Role | What they receive |
|---|---|---|
| Customized allogenic bone block | Other | 1 group to study Receives: Procedure: Customized allogenic bone block surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological study
histological study (histological analysis). Histomorphometry analysis will be performed at 5 months during the implant placement surgery.
Measured: 2 years
Bone volumetric changes
The bone volumetric changes of allograft bone blocks in the posterior site of the mandible. To assess the bone changes before and after implant treatment, CBCT scans are taken before bone regeneration, before implant placement at 4 months and 12 months after bone regeneration (Heigh and width) (mm)
Measured: 2 years
Secondary outcomes (3)
Survival rate of dental implants
Survival rate of dental implants placed in the allograft regenerated area (implants % survival)
Measured: 2 years
Success rate
Success rate of dental implants placed in the allograft regenerated area (implants without complications after 2 yerars)
Measured: 2 years
Complications
Evaluate the number of complications associated to this technique (%)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start25 May 2024 (estimated)
- Primary completion25 Sep 2024 (estimated)
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi Gargallo-Albiol, Universitat Internacional de Catalunya
- Investigators
- JORDI GARGALLO-ALBIOL, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937035
- Sponsor's protocol ID
- CIR-ECL-2022-02
- Status last verified
- Apr 2024
- First submitted
- 9 May 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Volumetric Evaluation of Customized Allograft Bone Blocks in Severe Atrophy of the Mandible: a Prospective Cohort Clinical Trial
- ClinicalTrials.gov ID
- NCT05937035
- Acronym / sponsor ID
- CIR-ECL-2022-02
- Conditions
- Alveolar Bone Resorption, Graft Overgrowth, Resorption of Bone Graft, Graft Complication, Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 25 May 2024 (estimated)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 10 Jul 2023 (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.
Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications.
Objectives: The primary aim of this study is to determine the bone regeneration capacity through a histological study and the bone volumetric changes of allograft bone blocks in the posterior site of the mandible. The secondary outcome will be to assess the survival and success rate of dental implants placed in the allograft regenerated area.
Materials and Methods: After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.
Detailed description
Allogenic bone blocks are a great bone regeneration technique option comparing to autologous regeneration treatments. There are several techniques of vertical guided bone regeneration but also have a large number of complications and failures. Some of the advantages of Customized Allograft Bone Blocks are: less invasive, causes less morbidity and resorption of the recipient site. Non resorbable membranes with particulate grafting material and autologous bone blocks are technically demanding and difficult to achieve stability to create new bone. Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. It is important to place the implants in an ideal prosthetic position to achieve excellent long-term results. Implant supported prosthesis can be contraindicated because of the lack of bone. Looking in to the classification of CAWOOD and HOWEL type 5 bone need bone augmentation techniques. In some cases, increasing the difficulty with the superficialization of the alveolar nerve. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications. The use of autogenous bone increases the risk of damaging anatomical structures increasing the morbidity, however thanks to allograft the investigators can avoid these problems. There are many different types of allografts, fresh-frozen bone (FFBA), freeze-dried bone (FDBA), demineralised freeze-dried bone allograft (DFDBA) and mineralised processed bone (MPBA). The allograft used for this study is a cellular cancellous bone material mechanically and chemically processed and sterilised by irradiation. This allogenic biomaterial has an osteoconductive property which facilitates the cell migration and proliferation for neoformation.
Study design A prospective controlled clinical trial will be conducted.
Residents of the International Master in Oral Surgery will perform the surgical and prosthodontic final rehabilitation procedures. All the included patients will sign an appropriate inform prior to any study-related actions. Firstly, an intraoral digital impression with intraoral scanner will be taken and a diagnostic wax-up will be performed. Subsequently, a cone-beam computed tomography scan would be taken in the specific area to be treated. After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. Releasing incisions will be performed to achieve the correct closure of the flap. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, photographs, periapical xrays digital impressions and 2nd CBCT will be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized allogenic bone block | Other | Procedure: Customized allogenic bone block surgery1 group to study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent
- Overall, healthy subjects (ASA1 and 2)
- Females and males of at least eighteen-years
- Requiring a posterior mandible rehabilitation with a minimum of 2 dental implants
- Able to follow instructions and attend a regular compliance
Key exclusion criteria (6 listed)
- Acute local infection
- Untreated periodontal disease assessed by Socransky et al. parameters (≥ 2mm clinical attachment loss in two consecutive visits within 1 year)
- Drug and/or alcoholic dependencies
- Medical conditions contraindicating implant surgery
- History of head and/or neck radiation
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 allogenic bone block surgeryAfter studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. Releasing incisions will be performed to achieve the correct closure of the flap. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, photographs, periapical xrays digital impressions and 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns. | Procedure or surgery | Customized allogenic bone block |
Primary outcome
Histological study
Time frame: 2 years
histological study (histological analysis). Histomorphometry analysis will be performed at 5 months during the implant placement surgery.
Bone volumetric changes
Time frame: 2 years
The bone volumetric changes of allograft bone blocks in the posterior site of the mandible. To assess the bone changes before and after implant treatment, CBCT scans are taken before bone regeneration, before implant placement at 4 months and 12 months after bone regeneration (Heigh and width) (mm)
3 secondary outcomes
Survival rate of dental implants
Time frame: 2 years
Success rate
Time frame: 2 years
Complications
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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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 GARGALLO-ALBIOL principal investigator
Universitat Internacional de Catalunya
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 allogenic bone block surgery in people with Alveolar Bone Resorption and Graft Overgrowth, 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 5 inclusion and 6 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 30 Apr 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. 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 JAVIER GAMON VIDAL (+34627321249, jgamon@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological study (time frame: 2 years). 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 30 Apr 2024.