Histological and Volumetric Evaluation of Customized Allograft Bone Blocks

NCT05937035 | Recruiting

• 1 other identifier: CIR-ECL-2022-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alveolar Bone Resorption; Graft Overgrowth; Resorption of Bone Graft; Graft Complication; Block

Outcome Measures

Primary Outcomes (2)

• Histological study

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

  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)

  2 years

Secondary Outcomes (3)

• Survival rate of dental implants

  2 years

• Success rate

  2 years

• Complications

  2 years

Study Arms (1)

Customized allogenic bone block

OTHER

1 group to study

Procedure: Customized allogenic bone block surgery

Interventions

Customized allogenic bone block surgery PROCEDURE

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.

Customized allogenic bone block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Bites and Stings

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• JORDI GARGALLO-ALBIOL

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JAVIER GAMON VIDAL

CONTACT

+34627321249; jgamon@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD Prof.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: July 10, 2023
• Study Start: May 25, 2024
• Primary Completion: September 25, 2024
• Study Completion: July 25, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

ES (1)