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Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.

ABSTRACT: PURPOSE:This study aimed to evaluate the quality and quantity of newly generated bone in the maxillary sinus grafted with stem cell-based allograft material. METHODS:This study was a single site, prospective, blinded, randomized, and controlled clinical trial. Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled. At the time of sinus augmentation, test sinus was grafted with stem cell-based allograft (Osteocel Plus; NuVasive Therapeutics), while the control sinus was grafted with conventional cortico-cancellous allograft (alloOss; ACE Surgical). Cone beam computer tomography (CBCT) scan was taken before and 14?weeks post-sinus augmentation procedure, i.e., 2?weeks before implant placement. Thirty-six trephined core bone biopsies were harvested from the anterior and posterior grafted lateral-window osteotomy sites at the time of implant placement. RESULTS:The results showed a statistically significant difference in the vital bone percentage between the test and the control groups at the posterior grafted sites (p = 0.03). There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05). The CBCT analysis showed that the maxillary sinuses at the posterior grafted sites were statistically wider than those at the anterior grafted sites in both groups (p < .05). CONCLUSIONS:Different allograft bone materials can be used in the maxillary sinus augmentation procedures. Stem cell allograft has more osteogenic potential with a better outcome in the wide posterior sinus.

SUBMITTER: Whitt J

PROVIDER: S-EPMC7321846 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.

Whitt Josh J Al-Sabbagh Mohanad M Dawson Dolphus D Shehata Ehab E Housley-Smith Moly M Tezanos Alejandro A Kutkut Ahmad A

International journal of implant dentistry 20200629 1

<h4>Purpose</h4>This study aimed to evaluate the quality and quantity of newly generated bone in the maxillary sinus grafted with stem cell-based allograft material.<h4>Methods</h4>This study was a single site, prospective, blinded, randomized, and controlled clinical trial. Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled. At the time of sinus augmentation, test sinus was grafted ...[more]

PMID: 32596764

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Project description:BackgroundEvidence has been provided that a cell-based therapy combined with the use of bioactive materials may significantly improve bone regeneration prior to dental implant, although the identification of an ideal source of progenitor/stem cells remains to be determined.AimIn the present research, the bone regenerative property of an emerging source of progenitor cells, the amniotic epithelial cells (AEC), loaded on a calcium-phosphate synthetic bone substitute, made by direct rapid prototyping (rPT) technique, was evaluated in an animal study.Material and methodsTwo blocks of synthetic bone substitute (?0.14 cm(3)), alone or engineered with 1×10(6) ovine AEC (oAEC), were grafted bilaterally into maxillary sinuses of six adult sheep, an animal model chosen for its high translational value in dentistry. The sheep were then randomly divided into two groups and sacrificed at 45 and 90 days post implantation (p.i.). Tissue regeneration was evaluated in the sinus explants by micro-computer tomography (micro-CT), morphological, morphometric and biochemical analyses.Results and conclusionsThe obtained data suggest that scaffold integration and bone deposition are positively influenced by allotransplantated oAEC. Sinus explants derived from sheep grafted with oAEC engineered scaffolds displayed a reduced fibrotic reaction, a limited inflammatory response and an accelerated process of angiogenesis. In addition, the presence of oAEC significantly stimulated osteogenesis either by enhancing bone deposition or making more extent the foci of bone nucleation. Besides the modulatory role played by oAEC in the crucial events successfully guiding tissue regeneration (angiogenesis, vascular endothelial growth factor expression and inflammation), data provided herein show that oAEC were also able to directly participate in the process of bone deposition, as suggested by the presence of oAEC entrapped within the newly deposited osteoid matrix and by their ability to switch-on the expression of a specific bone-related protein (osteocalcin, OCN) when transplanted into host tissues.

Project description:BackgroundAutogenous bone graft is considered as the preferred grafting material for maxillary sinus floor augmentation (MSFA). However, harvesting of extraoral or intraoral autogenous bone graft is associated with risk of donor site morbidity and supplementary surgery. From a clinical and patient perspective, it would therefore be an advantage, if postoperative discomfort could be minimized by diminishing the need for autogenous bone graft harvesting. The objective of the present study was to test the hypothesis of no difference in patient's perception of recovery after MSFA with autogenous bone graft from the zygomatic buttress (control) compared with 1:1 mixture of autogenous bone graft and deproteinized porcine bone mineral (DPBM) (Test I) or biphasic bone graft material (BBGM) (Test II). Sixty healthy patients were randomly allocated to either control or test groups. Oral Health-related Quality of Life (OHRQoL) was evaluated by Oral Health Impact Profile-14 (OHIP-14) at enrollment. Recovery was estimated by self-administrated questionnaires and visual analog scale assessing pain, social and working isolation, physical appearance, eating and speaking ability, diet variations, sleep impairment and discomfort after 1 week and 1 month. Descriptive statistics was expressed as mean with standard deviation (SD). Correlation between OHRQoL at enrollment and recovery were assessed by linear regression. p-value below 0.05 was considered significant.ResultsTreatment satisfaction and willingness to undergo similar surgery were high in all groups. Average numbers of days with pain and sick leave were 3.5 (SD 3.9) and 0.5 (SD 1.2), respectively, with no significant difference between groups. Moreover, no significant difference in eating and speaking ability, physical appearance, work performance and sleep impairment were seen between groups. Mean OHIP-14 score at enrollment was 9.30 (SD 9.25) (control), 9.95 (SD 7.96) (Test I) and 8.15 (SD 9.37) (Test II), with no significant differences between groups. Impaired OHRQoL, gender or age seems not to predispose for delayed recovery or increased postoperative discomfort.ConclusionsMSFA with diminutive autogenous bone graft harvesting is associated with high patient satisfaction, limited postoperative discomfort and willingness to undergo similar surgery. Presurgical OHRQoL, gender or age seems not to be associated with impaired patient's perception of recovery.

Project description:ObjectivesTo evaluate the performances of six different bone substitute materials used as graft in maxillary sinus augmentation by means of histological and histomorphometric analysis of bone biopsies retrieved from human subjects after a 6-month healing period.Materials and methodsSix consecutive patients (3 males, 3 females, aged 50-72 years), healthy, nonsmokers, and with good oral hygiene, presenting edentulous posterior maxilla with a residual bone crest measuring ≤ 4 mm in vertical height and 3 to 5 mm in horizontal thickness at radiographic examination, were selected to receive sinus augmentation and delayed implant placement. Under randomized conditions, sinus augmentation procedures were carried out using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anorganic bovine bone (ABB), equine-derived bone (EB), synthetic micro-macroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyapatite (HA-β-TCP 30/70), or bioapatite-collagen (BC). After 6 months, bone core biopsies were retrieved and 13 implants were placed. Bone samples were processed for histological and histomorphometric analysis. CT scans were taken before and after surgery. After 4 months of healing, patients were restored with a provisional fixed acrylic resin prosthesis, as well as after further 2-4 months with a definitive cemented zirconia or porcelain-fused-to-metal crowns.ResultsThere were no postoperative complications or implant failures. The histological examination showed that all biomaterials were in close contact with newly formed bone, surrounding the graft granules with a bridge-like network. No signs of acute inflammation were observed. The histomorphometry revealed 20.1% newly formed bone for MCBA, 32.1% for FDBA, 16.1% for ABB, 22.8% for EB, 20.3% for HA-β-TCP 30/70, and 21.4% for BC.ConclusionsWithin the limitations of the present investigation, all the six tested biomaterials showed good biocompatibility and osteoconductive properties when used in sinus augmentation procedures, although the FDBA seemed to have a better histomorphometric result in terms of newly formed bone and residual graft material. This trial is registered with ClinicalTrials.gov Identifier (Registration Number): NCT03496688.

Dataset Information

Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.

Publications

Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.

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