Clinical trial NCT03412838: Factors Influencing Bone Block Allograft Resorption
Official title: Factors Influencing Bone Block Allograft Resorption. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graft Loss
Keywords: Bone block allograft
Bone density
Graft resorption
PRP
RCT
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Bone Augmentation
timeFrame: 0 months
Secondary outcomes:
measure: Percentage of bone resorption
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Complutense de Madrid
name: Jesus Torres
role: PRINCIPAL_INVESTIGATOR
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