Allograft Ridge Augmentation: 3D Analysis of CAD/CAM Custom Milled and Prefabricated Conventional Allogeneic Bone Blocks and Dental Implant Follow-up

NCT06027710 | Unknown

• 1 other identifier: USC 68/2022
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the therapy of choice if the indication is suitable. In order to successfully place implants in the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is necessary. Human bone is generally always in the process of reconstruction and changes over time. If there is not enough substance left for rehabilitation with implants due to previous degradation of the alveolar bone, bone augmentation can be performed. For this purpose, mainly autogenous, xenogenic or allogenic bone material is used. Bone augmentation using allografts shows satisfactory results in clinical use and has advantages such as elimination of morbidity associated with autogenous bone graft harvesting. In addition to the use of conventional and prefabricated graft blocks, it is now possible to produce individual allogeneic bone blocks using computer-aided design based on the patient's radiological data. After this bone has been placed in the patient, it can be restored with implants after a healing phase of about 6 months. In order to make the treatment as predictable as possible, it is crucial to know how a bone augmentation changes over time and whether bone remodelling or resorption occurs. How allogeneic bone blocks behave with regard to their stability and treatment success has already been investigated in some studies, but to date there is no study that deals with the difference between prefabricated, conventional and individually manufactured CAD/CAM allogeneic bone blocks. By retrospectively analysing existing clinical data, the aim is to compare how the two methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the healing phase. A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography scans) will be performed, which allows not only linear punctual evaluation but also area and volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined in terms of survival rate, complication rate and marginal bone loss by evaluation of the available follow-up records of up to 12 years.

Conditions

Alveolar Ridge Augmentation

Keywords

Allograft; Dental Implants; Bone Substitutes; Three-dimensional Imaging; Alveolar Ridge Augmentation

Outcome Measures

Primary Outcomes (1)

• Bone graft volume (Vol, in mm³)

  Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)

  t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline

Secondary Outcomes (4)

• Mean linear distance (in mm)

  t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline

• Mean marginal bone loss (in mm)

  Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient

• Implant survival rate

  Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient

• Implant complication rate (biological and technical)

  Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient

Study Arms (2)

Prefabricated allogeneic bone blocks

Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.

Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft

CAD/CAM custom milled allogeneic bone blocks

\- Group B: horizontal and/or vertical augmentation of allogeneic bone replacement material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: individually planned, CAD/CAM custom-produced bone blocks

Procedure: Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft

Interventions

Extensive alveolar ridge augmentation with allogeneic bone blocks; dental implant insertion in allogeneic bone graft PROCEDURE

Alveolar ridge augmentation procedure for extensive bone defect rehabilitation in the upper and/or lower jaw allogeneic bone blocks; dental implant insertion in allogeneic bone graft for oral rehabilitation after 6 month of healing

CAD/CAM custom milled allogeneic bone blocks; Prefabricated allogeneic bone blocks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient treatment records of the study center of the last 12 years will be filtered for the treatment under investigation and eligibility criteria described and, if criteria are met, üatients are included in the retrospective analysis.

You may qualify if:

• Treated with the defined allogeneic bone substitute material
• Received the defined standardized intervention
• Number of missing teeth in the bone defect region ≥ 3
• CBCT scans recorded and available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)

You may not qualify if:

• Treated with a different bone substitute material than the one defined for investigation
• Received an other intervention than the defined standardized procedure
• Number of missing teeth in the bone defect region \< 3
• One of the following CBCT scans not available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Friedrich-Alexander-Universität Erlangen-Nürnberg: collaborator

Study Sites (1)

Department of Stomatology, Faculty of Dentistry, University of Santiago de Compostela

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (1)

• Seidel A, Leira Y, Batalla P, Caneiro L, Wichmann M, Blanco J. Three-dimensional imaging analysis of CAD/CAM custom-milled versus prefabricated allogeneic block remodelling at 6 months and long-term follow-up of dental implants: A retrospective cohort study. J Clin Periodontol. 2024 Aug;51(8):1005-1016. doi: 10.1111/jcpe.13995. Epub 2024 May 6.

  PMID: 38710641 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Juan Blanco Carrión

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 7, 2023
• Study Start: January 21, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)