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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

JAVIER GAMON VIDAL contact

+34627321249

jgamon@uic.es

Spain1 site, 1 recruiting
  • Universitat Internacional de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

    Iñigo Arévalo Lázaro, DDS, MSc, +34688692201, arevaloinigo@gmail.com

    Javier Gamón Vidal, +34627321249

    Recruiting

Other trials in Spain

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.

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 groups in NCT05937035
Study groupRoleWhat they receive
Customized allogenic bone blockOther1 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.

  1. Histological study

    histological study (histological analysis). Histomorphometry analysis will be performed at 5 months during the implant placement surgery.

    Measured: 2 years

  2. 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)
  1. Survival rate of dental implants

    Survival rate of dental implants placed in the allograft regenerated area (implants % survival)

    Measured: 2 years

  2. Success rate

    Success rate of dental implants placed in the allograft regenerated area (implants without complications after 2 yerars)

    Measured: 2 years

  3. 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.

  1. First posted10 Jul 2023
  2. Study start25 May 2024 (estimated)
  3. Primary completion25 Sep 2024 (estimated)
  4. Study completion25 Jul 2025 (estimated)

Resources

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)
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

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.

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