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Factors Influencing Bone Block Allograft Resorption

Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03412838
Enrollment
28
Registered
2018-01-26
Start date
2011-01-31
Completion date
2015-06-30
Last updated
2018-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Graft Loss

Keywords

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

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.

Detailed description

Introduction: 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. Materials and methods: 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. The aforementioned groups were compared in regards to bone resorption using General Estimating Equations (GEE) and logistic regression. Demographic data, trabecular bone density, graft site were also analyzed.

Interventions

PROCEDUREgraft surgery

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

Sponsors

Universidad Complutense de Madrid
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

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).

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Bone Augmentation0 monthsA 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.

Secondary

MeasureTime frameDescription
Percentage of bone resorption4 monthsA 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026