Factors Influencing Bone Block Allograft Resorption

NCT03412838 | Completed

• 1 other identifier: P-15/566
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

A main drawback of bone block graft surgery is the resorption occurring in early stages of healing. The aim of this work was investigate different factors associated with graft resorption in allogeneic bone block graft surgery.

Conditions

Graft Loss

Keywords

Bone block allograft; Bone density; Graft resorption; PRP; RCT

Outcome Measures

Primary Outcomes (1)

• Percentage of Bone Augmentation

  A region of interest (ROI) containing the entire trabecular bone area of the alveolar ridge was created using the closed polygon tool of the OsiriX software.

  0 months

Secondary Outcomes (1)

• Percentage of bone resorption

  4 months

Study Arms (2)

Cortico-Cancellous

ACTIVE COMPARATOR

Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement

Procedure: graft surgery

Cancellous

ACTIVE COMPARATOR

Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement

Procedure: graft surgery

Interventions

graft surgery PROCEDURE

A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants

Cancellous; Cortico-Cancellous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Twenty eight totally and partially edentulous patients referred for dental implant therapy from January 2011 to September 2015 were enrolled in the study. All patients had insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) that prevented placement of regular size implants

You may not qualify if:

• Patients with severe systemic disease (American Society of Anesthesiology III or IV) were excluded from the study. In addition, patients who were pregnant, or patients with diseases affecting bone, such as Paget's disease, osteomalacia, diabetes, vitamin D deficiency, alcoholism, hyperthyroidism cancer or osteoporosis as well as those on medications that might affect bone metabolism, such as bisphosphonates, corticosteroids or antiepileptic medicaments were also excluded from the study.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Related Publications (52)

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Study Officials

• Jesus Torres

  Universidad Complutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the cortico-cancellous group (CC), and cancellous group (C). Allocation of participants to intervention groups in a truly unpredictable, randomized sequence was performed using a computerized random number generated by the GraphPadQuickCalc software (GraphPad Software Inc., La Jolla, CA). Blocked randomization was performed to maintain equal group size. As a result 14 patients were randomly assigned to de CC group and other 14 to the C group. All bone augmentation surgeries were performed by the same oral surgeon, with expertise on block surgeries (JT).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Profesor

Model Details: Twenty-eight patients referred for implant placement and with insufficient bucco-lingual (BL) alveolar bone width (\<4 mm) were included in the study. Patients received freeze dried bone allograft (FDBA) blocks of either allogeneic cancellous or cortico-cancellous bone obtained from the iliac crest. Patients included in the clinical trial were randomly allocated by a blinded assistant in two groups: in the cortico-cancellous group (CC), and cancellous group (C).

Study Record Dates

• First Submitted: January 14, 2018
• First Posted: January 26, 2018
• Study Start: January 1, 2011
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2015
• Last Updated: January 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share