Remodeling of Prefabricated Conventional and CAD/CAM Custom Fabricated Allograft Blocks for Bone Augmentation - Volumetric Analysis and Dental Implant Follow-up
Sponsor study identifier
observational
20
1 country
1
Study Start
January 21, 2023
Actual (reported)Primary Completion
June 1, 2023
Actual (reported)Study Completion
September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 21, 2023
Actual (reported)June 1, 2023
Actual (reported)August 21, 2023
Actual (reported)September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 7, 2023
Actual (reported)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
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
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.
\- 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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Department of Stomatology, Faculty of Dentistry, University of Santiago de Compostela
Santiago de Compostela, A Coruña, 15782, Spain
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.
First Submitted
August 21, 2023
First Posted
September 7, 2023
Study Start
January 21, 2023
Actual (reported)Primary Completion
June 1, 2023
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
September 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 7, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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