Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

OBJECTIVES: To compare the clinical effects of concentrated growth factor (CGF) membrane and Bio-Gide ^® collagen membrane, combined with Bio-Oss ^® sticky bone respectively in alveolar ridge preservation (ARP) of maxillary anterior teeth. METHODS: Thirty patients who needed alveolar ridge preservation after maxillary anterior tooth extraction were selected and randomly assigned to the Bio-Gide group and the CGF group. In both groups, the extraction sockets were tightly filled with the Bio-Oss^® sticky bone. In the Bio-Gide group used Bio-Gide^® collagen membrane to cover the upper edge of the Bio-Oss^® sticky bone and closed the wound. The CGF group, the CGF membrane was covered on the upper edge of the Bio-Oss^® sticky bone and the wound was closed. The soft tissue wound healing status at 10 days after ARP, the changes in alveolar ridge height and width immediately after ARP and at 6 months after ARP, and the doctor-patient satisfaction at 6 months after ARP were compared and evaluated between the two groups. RESULTS: At 6 months after ARP, there was no statistically significant difference in the changes of alveolar bone width and height between the two groups (P>0.05). However, the CGF group showed better performance in soft tissue healing after ARP and doctor-patient satisfaction, and the differences were statistically significant (P<0.05). CONCLUSIONS Compared with the Bio-Gide^® collagen membrane, the combined application of CGF membrane and Bio-Oss^® sticky bone can lead to better soft tissue healing after ARP of maxillary anterior teeth and higher doctor-patient satisfaction, showing obvious advantages in ARP of maxillary anterior teeth.
Humans ; Maxilla/surgery* ; Tooth Extraction ; Alveolar Process/surgery* ; Membranes, Artificial ; Alveolar Ridge Augmentation/methods* ; Intercellular Signaling Peptides and Proteins/therapeutic use* ; Minerals/therapeutic use* ; Collagen ; Wound Healing ; Tooth Socket/surgery* ; Bone Substitutes/therapeutic use* ; Male ; Female ; Middle Aged ; Alveolar Bone Loss/prevention & control* ; Adult

BACKGROUNDRegenerative techniques help promote the formation of new attachment and bone filling in periodontal defects. However, the dimensions of intraosseous defects are a key determinant of periodontal regeneration outcomes. In this study, we evaluated the efficacy of use of anorganic bovine bone (ABB) graft in combination with collagen membrane (CM), to facilitate healing of noncontained (1-wall) and contained (3-wall) critical size periodontal defects.

METHODSThe study began on March 2013, and was completed on May 2014. One-wall (7 mm × 4 mm) and 3-wall (5 mm × 4 mm) intrabony periodontal defects were surgically created bilaterally in the mandibular third premolars and first molars in eight beagles. The defects were treated with ABB in combination with CM (ABB + CM group) or open flap debridement (OFD group). The animals were euthanized at 8-week postsurgery for histological analysis. Two independent Student's t-tests (1-wall [ABB + CM] vs. 1-wall [OFD] and 3-wall [ABB + CM] vs. 3-wall [OFD]) were used to assess between-group differences.

RESULTSThe mean new bone height in both 1- and 3-wall intrabony defects in the ABB + CM group was significantly greater than that in the OFD group (1-wall: 4.99 ± 0.70 mm vs. 3.01 ± 0.37 mm, P < 0.05; 3-wall: 3.11 ± 0.59 mm vs. 2.08 ± 0.24 mm, P < 0.05). The mean new cementum in 1-wall intrabony defects in the ABB + CM group was significantly greater than that in their counterparts in the OFD group (5.08 ± 0.68 mm vs. 1.16 ± 0.38 mm; P < 0.05). Likewise, only the 1-wall intrabony defect model showed a significant difference with respect to junctional epithelium between ABB + CM and OFD groups (0.67 ± 0.23 mm vs. 1.12 ± 0.28 mm, P < 0.05).

CONCLUSIONSOne-wall intrabony defects treated with ABB and CM did not show less periodontal regeneration than that in 3-wall intrabony defect. The noncontained 1-wall intrabony defect might be a more discriminative defect model for further research into periodontal regeneration.

Alveolar Bone Loss ; surgery ; Animals ; Biocompatible Materials ; therapeutic use ; Bone Regeneration ; physiology ; Bone Substitutes ; therapeutic use ; Cattle ; Dogs ; Guided Tissue Regeneration, Periodontal ; methods ; Male ; Wound Healing ; physiology

Bone is a unique organ composed of mineralized hard tissue, unlike any other body part. The unique manner in which bone can constantly undergo self-remodeling has created interesting clinical approaches to the healing of damaged bone. Healing of large bone defects is achieved using implant materials that gradually integrate with the body after healing is completed. Such strategies require a multidisciplinary approach by material scientists, biological scientists, and clinicians. Development of materials for bone healing and exploration of the interactions thereof with the body are active research areas. In this review, we explore ongoing developments in the creation of materials for regenerating hard tissues.
Animals ; Bone Regeneration/*drug effects ; Bone Substitutes/*therapeutic use ; Bone and Bones/*drug effects/pathology/physiopathology ; Ceramics/therapeutic use ; Diffusion of Innovation ; Fracture Healing/drug effects ; Humans ; Hydrogels ; Polymers/therapeutic use ; Regenerative Medicine/*trends ; Tissue Engineering/*trends ; Treatment Outcome

BACKGROUND: Bioactive glass-ceramics have the ability to directly bind to bones and have been widely used as bone graft substitutes due to their high osteoconductivity and biocompatibility. CaO-SiO2-P2O5-B2O3 glass-ceramics are known to have good osteoconductivity and are used as bone graft extenders. METHODS: This study aimed to evaluate the effects of the resorbing properties of glass-ceramics in bone fusion after producing and analyzing three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with high osteoconductivity that had enhanced resorption by having an increased B2O3 content. The three types of CaO-SiO2-P2O5-B2O3 glass-ceramics with B2O3 contents of 8.0, 9.0, and 9.5 weight % were designated and grouped as P20B80, P10B90, and P5B95, respectively. Glass-ceramic types were tested for fusion rates and bone formation by employing the lumbar 5-6 intertransverse process fusion model in 51 New Zealand male rabbits. Bioactivity was assessed by soaking in simulated body fluid (SBF). RESULTS: In vitro study results showed sufficient hydroxycarbonate apatite layer formation occurred for P20B80 in1 day, for P10B90 in 3 days, and for P5B95 in 5 days after soaking in SBF. For the rabbit lumbar spine posterolateral fusion model, the autograft group recorded a 100% fusion rate with levels significantly higher than those of P20B80 (29.4%), P10B90 (0%), and P5B95 (14.3%), with high resorbing properties. Resorbing property differences among the three glass-ceramic groups were not significant. Histological results showed new bone formation confirming osteoconductivity in all three types of glass-ceramics. Radiomorphometric results also confirmed the resorbing properties of the three glass-ceramic types. CONCLUSIONS: The high resorbing properties and osteoconductivity of porous glass-ceramics can be advantageous as no glass-ceramics remain in the body. However, their relatively fast rate of resorption in the body negatively affects their role as an osteoconductive scaffold as glass-ceramics are resorbed before bony fusion.
Animals ; Bone Resorption ; Bone Substitutes/adverse effects/*therapeutic use ; Ceramics/adverse effects/*therapeutic use ; Electric Conductivity ; Lumbosacral Region/*surgery ; Male ; Rabbits ; Spinal Fusion/*methods

Biomechanical Phenomena ; Bone Substitutes ; therapeutic use ; Child ; Facial Bones ; physiology ; Fracture Fixation, Internal ; Fracture Healing ; Humans ; Skull ; physiology ; Skull Fractures ; therapy ; Stress, Mechanical

Alveolar Bone Loss ; diagnostic imaging ; etiology ; prevention & control ; surgery ; Alveolar Process ; diagnostic imaging ; pathology ; Bone Substitutes ; therapeutic use ; Cone-Beam Computed Tomography ; Dental Implantation ; methods ; Guided Tissue Regeneration, Periodontal ; methods ; Humans

Animals ; Biocompatible Materials ; therapeutic use ; Bone Regeneration ; Bone Substitutes ; therapeutic use ; Bone Transplantation ; Collagen ; therapeutic use ; Guided Tissue Regeneration, Periodontal ; methods ; Humans ; Membranes, Artificial ; Periodontal Diseases ; surgery ; Polytetrafluoroethylene ; therapeutic use

OBJECTIVETo evaluate the long-term clinical outcome of delayed implant placements after maxillary sinus floor augmentation with autologous bone or Bio-Oss grafting.

METHODSEighteen patients underwent maxillary sinus floor augmentation and delayed implant placements from January, 2002 to December, 2008. Bone grafting and sinus floor augmentation were performed in 21 sides of maxilla and 46 implants were placed 6 - 8 months later. Residual bone height was less than 4 mm. The cases were divided to 2 groups and different materials (autologous bone + Bio-Oss and Bio-Oss alone) were grafted relatively. The bone resorption was assessed by panoramic X-ray and the stability of the implant was reviewed postoperatively.

RESULTSThe average follow-up time was 54 months. Only one implant was lost and the implant survival rate was 98%. X-ray showed that the bone resorption was observed in both groups. The absorption ratio of autologous bone + Bio-Oss group was 18.65% and that of the Bio-oss group was 1.93%. The difference was significantly different.

CONCLUSIONSThe result of maxillary sinus floor augmentation with bone grafting was predictable. More bone absorption occurred in the Bio-Oss than in autologous bone + Bio-Oss.

Adult ; Bone Substitutes ; therapeutic use ; Bone Transplantation ; methods ; Collagen ; therapeutic use ; Dental Implantation, Endosseous ; methods ; Female ; Follow-Up Studies ; Humans ; Jaw, Edentulous, Partially ; diagnostic imaging ; surgery ; Male ; Maxilla ; diagnostic imaging ; Middle Aged ; Minerals ; therapeutic use ; Radiography, Panoramic ; Sinus Floor Augmentation ; methods ; Young Adult

OBJECTIVETo investigate the early outcome of vertical expandable prosthetic titanium rib (VEPTR) technique in treating early-onset scoliosis.

METHODSThis study recruited 11 early-onset scoliosis patients (8 boys and 3 girls) who received VEPTR treatment from December 2006 to July 2011 with a minimum follow-up of 12 months. The average age at initial surgery was (7 ± 3) years (range, 3.1 to 9.8 years). VEPTR device, either rib to rib or rib to lumbar, was implanted at initial surgery. During the regular post-operative follow-ups, expansion surgeries were scheduled at an interval of 6 to 12 months. Measurements of primary curve magnitude, apical vertebral translation, thoracic height and T(1)-S(1) height were performed on radiographs, and were compared between those of preoperatively, postoperatively, and at latest follow-up through paired-t tests.

RESULTSAll patients had a mean follow-up of (32 ± 11) months. Totally 41 surgeries were performed, averagely 3.7 surgeries per patient; and 30 expansion surgeries were carried out, averagely 2.7 surgeries per patient. The average interval for each expansion surgery was 8 months. From preoperatively to latest follow-up, the Cobb angle of primary curves was averagely corrected from 78° ± 18° to 55° ± 11° (t = 4.931, P < 0.05), and apical vertebral translation and thoracic kyphosis displayed slight improvement. Average thoracic height increased from (13.3 ± 2.0) cm to (17.2 ± 2.4) cm (t = 8.365, P < 0.001), and average T(1)-S(1) height from (24.4 ± 3.8) cm to (32.5 ± 5.3) cm (t = 9.080, P < 0.001). After initial surgery with VEPTR instrumented, gains in thoracic height and T(1)-S(1) height per expansion surgery averaged (0.8 ± 0.3) cm and (1.8 ± 0.4) cm, respectively. Eight complications occurred in 6 patients, including rib cradle dislodgements, displayed infection, intraoperative pleura rupture and loosening of lumbar pedicle screws.

CONCLUSIONSVEPTR technique proves to be an effective way of preventing curve progression in early-onset scoliosis patients while allowing growth of spine and chest. Yet, indications for such a technique need to be strictly selected because of the relatively high complication rate.

Age of Onset ; Bone Substitutes ; therapeutic use ; Child ; Child, Preschool ; Female ; Follow-Up Studies ; Humans ; Male ; Postoperative Complications ; epidemiology ; Ribs ; Scoliosis ; surgery ; Spine ; anatomy & histology ; surgery ; Titanium ; Treatment Outcome