Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
28 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-01-31
Study Completion Date
2015-06-30
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Graft Loss
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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).
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
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).
Study Groups
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Cortico-Cancellous
Graft surgery with cortico-cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
Group Type
ACTIVE_COMPARATOR
graft surgery
Intervention Type
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
Graft surgery with cancellous block, freeze dried bone allograft (FDBA) for treatment the atrophic maxilla prior implant placement
Group Type
ACTIVE_COMPARATOR
graft surgery
Intervention Type
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
Interventions
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graft 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
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Sponsor Role
lead
Responsible Party
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Jesús Torres García Denche
Associate Profesor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jesus Torres
Role: PRINCIPAL_INVESTIGATOR
Universidad Complutense de Madrid
References
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Other Identifiers
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P-15/566
Identifier Type: -
Identifier Source: org_study_id
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