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Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

ABSTRACT: Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling.A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements.The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement.ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

SUBMITTER: Rignon-Bret C

PROVIDER: S-EPMC4875593 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

Rignon-Bret Christophe C Hadida Alain A Aidan Alexis A Nguyen Thien-Huong TH Pasquet Gerard G Fron-Chabouis Helene H Wulfman Claudine C

Trials 20160520 1

<h4>Background</h4>Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to ev ...[more]

PMID: 27206923

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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:BACKGROUND/AIM:The present study investigates the in vivo tissue reaction and the integration behavior of an injectable bone substitute material (IBS) composed of a water-based gel combined with nano hydroxyapatite particles and biphasic calcium phosphate granules. The results of the IBS were compared to biphasic bone substitute granules (BBSM) of the same chemical composition. MATERIALS AND METHODS:The subcutaneous implantation model in 40 female 5-week-old CD-1 mice up to 60 days after implantation was used for conduction of the in vivo experiments. Moreover, established histological, histopathological and histomorphometrical methods were applied. RESULTS:The results showed that the IBS was gradually invaded by cells and complex tissue elements. Thus, the implant bed could be distinguished in two areas, i.e. an outer and inner region. While the outer region started to interact with the peri-implant tissue by evoking multinucleated giant cells and at earlier time points by undergoing a continuous high vascularization, the inner part was free of peri-implant cells for at least 30 days, starting to undergo a similar tissue reaction at a later time point. The bone substitute granules allowed for a fast tissue influx between the interspaces of the granules starting at day 10. While the vessel density did not differ in both groups up to the end of the study, the amount of vascularization was significantly higher over the entire observation period in the BBSM group. Moreover, the amount of biomaterial-associated multinucleated giant cells (BMGCs) was significantly higher in the IBS group in the period of between 15 to 30 days after implantation, while comparable BMGC numbers were found in both groups towards the end of the study. CONCLUSION:IBS can build a barrier-like structure that is able to control the soft tissue influx into the central regions of the implantation bed, which could not be observed in other bone substitute granules of the same chemical composition. This directed integration behavior is assumed to be in accordance with the concept of Guided Bone Regeneration (GBR). Furthermore, BMGCs can significantly influence the process of angiogenesis within an implant bed of a biomaterial but not the maturity of blood vessels.

Project description:OBJECTIVE:To explore the feasibility of immediate implantation after tooth extraction in the maxillary molar socket with poor bone quality beneath the sinus. METHODS:We collected the data from the patients undergoing extraction of maxillary molars with poor bone quality between the sockets and sinuses. Sinus lifting and immediate implant following the extraction were performed simultaneously in these cases, and the primary stability of the implants, wound healing, and changes of the sinus were observed. At 6 months after the operations, the crowns were installed on the implants. The masticatory function was observed, and the growth of the alveolar bones and their changes after the operations were examined using microcomputed tomography (MCT). RESULTS:We analyzed 32 extraction cases with immediate implantation in the maxillary molar sockets with poor bone quality beneath the sinus. The average age of the patients was 59.8 years, and the length and diameter of the implant ranged from 8.5 to 10 mm and from 4.5 to 5.5 mm, respectively. The torque force of the implants varied from the minimum (in which cases the implants remained fixed after insertion with fingers) to the maximum of 30 N·cm. The postoperative recovery was uneventful in all the cases and no failed or movable implants were found. At 6 months after the operation, none of the patients showed abnormalities in the sinus, and in all the cases the crowns were successfully installed on the implants with good recovery of the masticatory functions. Follow-up of the patients for 12 to 96 months after the operation showed successful immediate implantation in all the cases. After the operation, the changes of the mean alveolar ridge heights on the buccal, palatal, mesial, and distal sides of the patients were 0.8069±0.6253 mm (t=1.2904, P>0.1), 0.5272± 0.3331 mm (t=1.5836, P>0.05), 0.5416±0.4048 mm (t=1.3379, P>0.05), and 0.5172±0.3874 mm (t=1.3351, P>0.05), respectively; the change of the alveolar ridge width was 0.5522±0.4381 mm (t=1.2604, P>0.1) mm. The dimension of the alveolar bone underwent no significant changes after the operation in these patients. CONCLUSIONS:Immediate implantation in the maxillary extraction socket with a poor bone quality can avoid damages to the sinus and achieve good outcomes with such advantages of less trauma, full use of the innate gingiva and alveolar ridge, and well preserved morphology of the alveolar ridge as compared with delayed implantation.

Project description:ObjectiveTo assess the efficacy of using a bone substitute material (BSM) in the fixture-socket gap in patients undergoing tooth extraction and immediate implant placement.Materials and methodsMEDLINE, EMBASE, and CENTRAL databases were searched for randomized controlled trials (RCTs). RCTs were screened for eligibility, and data were extracted by two authors independently. Risk of bias (ROB) was assessed using Cochrane's ROB tool 2.0. Primary outcomes were implant failure, overall complications, and soft-tissue esthetics. Secondary outcomes were vertical buccal bone resorption, vertical interproximal bone resorption, horizontal buccal bone resorption, and mid-buccal mucosal recession. Meta-analysis was performed using random-effects model with generic inverse variance weighing. GRADE was used to grade the certainty of the evidence.ResultsAfter screening 19 544 potentially eligible references, 20 RCTs were included in this review, with a total of 848 patients (916 sites). Most included RCTs were deemed of some concerns (53%) or at low (38%) risk of bias, except for overall complications (high ROB). Implant failure did not differ significantly RR = 0.92 (confidence intervals [CI] 0.34 to 2.46) between using a BSM compared with not using a BSM (NoBSM). BSM use resulted in less horizontal buccal bone resorption (MD = -0.52 mm [95% CI -0.74 to -0.30]), a higher esthetic score (MD = 1.49 [95% CI 0.46 to 2.53]), but also more complications (RR = 3.50 [95% CI 1.11 to 11.1] compared with NoBSM. Too few trials compared types of BSMs against each other to allow for pooled analyses. The certainty of the evidence was considered moderate for all outcomes except implant failure (low), overall complications (very low), and vertical interproximal bone resorption (very low).ConclusionBSM use during immediate implant placement reduces horizontal buccal bone resorption and improves the periimplant soft-tissue esthetics. Although BSM use increases the risk of predominantly minor complications.

Project description:Background: Treatment of large bone defects represents a major clinical problem worldwide. Suitable bone substitute materials are commonly required to achieve successful bone regeneration, and much effort has been spent to optimize their chemical compositions, 3D architecture and mechanical properties. However, material-immune system interactions are increasingly being recognized as a crucial factor influencing regeneration. Here, we envisioned an accurate and proactive immunomodulation strategy via delivery of IL-4 (key regulator of macrophage polarization) to promote bone substitute material-mediated regeneration. Methods: Four different IL-4 doses (0 ng, 10 ng, 50 ng and 100 ng) were delivered into rat large cranial bone defects at day 3 post-operation of decellularized bone matrix (DBM) material implantation, and the osteogenesis, angiogenesis and macrophage polarization were meticulously evaluated. Results: Micro-CT analysis showed that immunomodulation with 10 ng IL-4 significantly outperformed the other groups in terms of new bone formation (1.23-5.05 fold) and vascularization (1.29-6.08 fold), achieving successful defect bridging and good vascularization at 12 weeks. Histological analysis at 7 and 14 days showed that the 10 ng group generated the most preferable M1/M2 macrophage polarization profile, resulting in a pro-healing microenvironment with more IL-10 and less TNF-α secretion, a reduced apoptosis level in tissues around the materials, and enhanced mesenchymal stem cell migration and osteogenic differentiation. Moreover, in vitro studies revealed that M1 macrophages facilitated mesenchymal stem cell migration, while M2 macrophages significantly increased cell survival, proliferation and osteogenic differentiation, explaining the in vivo findings. Conclusions: Accurate immunomodulation via IL4 delivery significantly enhanced DBM-mediated osteogenesis and angiogenesis via the coordinated involvement of M1 and M2 macrophages, revealing the promise of this accurate and proactive immunomodulatory strategy for developing new bone substitute materials.

Dataset Information

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

Publications

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

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