RecruitingNot ApplicableNCT05937035

Histological and Volumetric Evaluation of Customized Allograft Bone Blocks

Histological and Volumetric Evaluation of Customized Allograft Bone Blocks in Severe Atrophy of the Mandible: a Prospective Cohort Clinical Trial


Sponsor

Universitat Internacional de Catalunya

Enrollment

10 participants

Start Date

May 25, 2024

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria6

  • 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

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Interventions

PROCEDURECustomized allogenic bone block 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.


Locations(1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

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NCT05937035


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