Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

Abstract Background The aim of this multicenter, randomized, open-label, comparative, investigator-blinded study was to investigate the efficacy and safety of recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with β-TCP (rhBMP-2/β-TCP) in alveolar ridge preservation. Materials and methods Eighty-four subjects from three centers were enrolled in this clinical trial. After tooth extraction, rhBMP-2/β-TCP (n = 41, test group) or β-TCP (n = 43, control group) were grafted to the extraction socket with an absorbable barrier membrane for alveolar ridge preservation. Using computed tomography images obtained immediately after and 12 weeks after surgery, changes in the alveolar bone height and width were analyzed for each group and compared between the two groups. Results Both the test and control groups showed a significant decrease in alveolar bone height in the 12 weeks after surgery (both groups, p < 0.0001). However, the test group exhibited a significantly lower decrease in alveolar bone height than the control group (p = 0.0004). Alveolar bone width also showed significantly less resorption in the test group than in the control group for all extraction socket levels (ESL) (p = 0.0152 for 75% ESL; p < 0.0001 for 50% ESL; p < 0.0001 for 25% ESL). There were no statistically significant differences in the incidence of adverse events between the two groups. No severe adverse events occurred in either group. Conclusions The results of this study suggest that rhBMP-2/β-TCP is a safe graft material that provides a high alveolar bone preservation effect in patients receiving dental extraction. Trial registration Clinicaltrials.gov, NCT02714829, Registered 22 March 2016

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Calcium Phosphate Modified with Silicon vs. Bovine Hydroxyapatite for Alveolar Ridge Preservation: Densitometric Evaluation, Morphological Changes and Histomorphometric Study

Materials ◽

10.3390/ma14040940 ◽

2021 ◽

Vol 14 (4) ◽

pp. 940

Author(s):

Guillermo Cadenas-Vacas ◽

Natalia Martínez-Rodríguez ◽

Cristina Barona-Dorado ◽

Luis Sánchez-Labrador ◽

Jorge Cortés-Bretón Brinkmann ◽

...

Keyword(s):

Calcium Phosphate ◽

Bone Density ◽

Bone Loss ◽

Alveolar Bone ◽

Morphological Changes ◽

Test Group ◽

Control Group ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Alveolar Ridge Preservation

After tooth extraction, the alveolar bone undergoes a physiological resorption that may compromise the future placement of the implant in its ideal position. This study evaluated bone density, morphological changes, and histomorphometric results undergone by alveolar bone after applying a new biomaterial composed of calcium phosphate modified with silicon (CAPO-Si) compared with hydroxyapatite of bovine origin (BHA). Alveolar ridge preservation (ARP) was performed in 24 alveoli, divided into a test group filled with CAPO-Si and a control group filled with BHA. Three months later, the mineral bone density obtained by the biomaterials, horizontal and vertical bone loss, the degree of alveolar corticalization, and histomorphometric results were evaluated. Both biomaterials presented similar behavior in terms of densitometric results, vertical bone loss, and degree of alveolar corticalization. Alveoli treated with CAPO-Si showed less horizontal bone loss in comparison with alveoli treated with BHA (0.99 ± 0.2 mm vs. 1.3 ± 0.3 mm), with statistically significant difference (p = 0.017). Histomorphometric results showed greater bone neoformation in the test group than the control group (23 ± 15% vs. 11 ± 7%) (p = 0.039) and less residual biomaterial (5 ± 10% vs. 17 ± 13%) (p = 0.043) with statistically significant differences. In conclusion, the ARP technique obtains better results with CAPO-Si than with BHA.

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Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial

Journal of Dental Research ◽

10.1177/0022034520905660 ◽

2020 ◽

Vol 99 (4) ◽

pp. 402-409 ◽

Cited By ~ 7

Author(s):

G. Avila-Ortiz ◽

M. Gubler ◽

M. Romero-Bustillos ◽

C.L. Nicholas ◽

M.B. Zimmerman ◽

...

Keyword(s):

Tooth Extraction ◽

Alveolar Bone ◽

Controlled Trial ◽

Control Group ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Bone Augmentation ◽

Randomized Controlled ◽

Implant Placement ◽

Alveolar Ridge Preservation

Alveolar ridge preservation (ARP) therapy is indicated to attenuate the physiologic resorptive events that occur as a consequence of tooth extraction with the purpose of facilitating tooth replacement therapy. This randomized controlled trial was primarily aimed at testing the efficacy of ARP as compared with unassisted socket healing. A secondary objective was to evaluate the effect that local phenotypic factors play in the volumetric reduction of the alveolar bone. A total of 53 subjects completed the study. Subjects were randomized into either the control group, which involved only tooth extraction (EXT n = 27), or the experimental group, which received ARP using a combination of socket grafting with a particulate bone allograft and socket sealing with a nonabsorbable membrane (dPTFE) following tooth extraction (ARP n = 26). A set of clinical, linear, volumetric, implant-related, and patient-reported outcomes were assessed during a 14-wk healing period. All linear bone assessments (horizontal, midbuccal, and midlingual reduction) revealed that ARP is superior to EXT. Likewise, volumetric bone resorption was significantly higher in the control group (mean ± SD: EXT = −15.83% ± 4.48%, ARP = −8.36% ± 3.81%, P < 0.0001). Linear regression analyses revealed that baseline buccal bone thickness is a strong predictor of alveolar bone resorption in both groups. Interestingly, no significant differences in terms of soft tissue contour change were observed between groups. Additional bone augmentation to facilitate implant placement in a prosthetically acceptable position was deemed necessary in 48.1% of the EXT sites and only 11.5% of the ARP sites ( P < 0.004). Assessment of perceived postoperative discomfort at each follow-up visit revealed a progressive decrease over time, which was comparable between groups. Although some extent of alveolar ridge remodeling occurred in both groups, ARP therapy was superior to EXT as it was more efficacious in the maintenance of alveolar bone and reduced the estimated need for additional bone augmentation at the time of implant placement (ClinicalTrials.gov NCT01794806).

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Efficacy of Alveolar Ridge Preservation after Maxillary Molar Extraction in Reducing Crestal Bone Resorption and Sinus Pneumatization: A Multicenter Prospective Case-Control Study

BioMed Research International ◽

10.1155/2018/9352130 ◽

2018 ◽

Vol 2018 ◽

pp. 1-9 ◽

Cited By ~ 33

Author(s):

Teresa Lombardi ◽

Fabio Bernardello ◽

Federico Berton ◽

Davide Porrelli ◽

Antonio Rapani ◽

...

Keyword(s):

Bone Resorption ◽

Alveolar Bone ◽

Test Group ◽

Control Group ◽

Ridge Preservation ◽

Alveolar Ridge Preservation ◽

Maxillary Molar ◽

Socket Healing ◽

Maxillary Molar Extraction ◽

Molar Extraction

Aim. To evaluate, with three-dimensional analysis, the effectiveness of alveolar ridge preservation (ARP) after maxillary molar extraction in reducing alveolar bone resorption and maxillary sinus pneumatization when compared to unassisted socket healing. Methods. Patients were included in the study following inclusion criteria and underwent minimally traumatic maxillary molar extraction followed by ARP using synthetic nanohydroxyapatite (Fisiograft Bone, Ghimas, Italy) (test group) or unassisted socket healing (control group). Cone-beam computerized tomographies (CBCT) were performed immediately after tooth extraction (T0) and 6 months postoperatively (T1). CBCTs were superimposed by using a specific software (Amira, Thermo Fisher Scientific, USA) and the following items were analyzed in both groups: (i) postextractive maxillary sinus floor expansion in coronal direction and (ii) postextractive alveolar bone dimensional changes (both vertical and horizontal). All data were tested for normality and equality of variance and subsequently analyzed by independent samples T-test and Mann–Whitney test. Results. Thirty patients were treated by three centers and twenty-six (test n=13; control n=13) were included in the final analysis. Mean sinus pneumatization at T1 was 0.69±0.48 mm in the test group and 1.04±0.67 mm in the control group (p=0.15). Mean vertical reduction of the alveolar bone at T1 was 1.62±0.49 mm in the test group and 2.01±0.84 mm in the control group (p=0.08). Mean horizontal resorption of crestal bone at T1 was 2.73±1.68 mm in test group and 3.63±2.24 mm in control group (p=0.24). Conclusions. It could be suggested that ARP performed after maxillary molar extraction may reduce the entity of sinus pneumatization and alveolar bone resorption, compared to unassisted socket healing. This technique could decrease the necessity of advanced regenerative procedures prior to dental implant placement in posterior maxilla.

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Clinical application of concentrate growth factors combined with bone substitute in Alveolar ridge preservation of anterior teeth

10.21203/rs.3.rs-1174819/v1 ◽

2021 ◽

Author(s):

Dilinuer Keranmu ◽

Nijiati Nuermuhanmode ◽

Ailimaierdan Ainiwaer ◽

Adili Moming ◽

Gu Li ◽

...

Keyword(s):

Growth Factors ◽

Alveolar Bone ◽

Gingival Tissue ◽

Control Group ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Anterior Teeth ◽

Alveolar Ridge Preservation ◽

Bone Powder ◽

Significant Difference

Abstract Objective: To investigate the clinical effect of concentrated growth factors (CGF) combined with Bio-oss bone powder on Alveolar ridge preservation (ARP) during implantology. Methods: A total of 38 patients were selected and randomly divided into 2 groups, with 19 cases in each group. The extraction sockets were filled with Bio-oss bone powder with or without CGF. VAS pain score was recorded within1 week and Landry wound healing index (LWHI) was recorded at 1, 2 and 3 weeks after operation. CBCT was taken 3 and 6 months after operation to measure and compare the changes of vertical height, width and gray value of alveolar bone at extraction site. The changes of alveolar bone contour were observed clinically and compared between the two groups. Results: The VAS score of CGF group was lower than control group on the 1st and 3rd day after operation (P < 0.05). The LWHI of CGF group was higher than control group 1 week after operation (P < 0.05). The absorption of the labial and palatal plates height and the width in the CGF group was significantly less than the control group at 3 months (P<0.05). The gray value of alveolar bone in CGF group was significantly higher than control group at 3 months (P < 0.05). There was no significant difference in new bone contour between the two groups (P > 0.05). 94.7% cases in CGF group did not undergo bone grafting, which was significantly higher than control group (78.9%). Conclusions: The use of CGF combined with Bio-oss bone powder can help to reduce postoperative pain at the early stage of healing, form sufficient keratinized gingival tissue, effectively maintain the height and width of alveolar bone in the three-dimensional direction and provide good conditions for implant repair in the future.

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The Efficacy and Safety of Indocyanine green- hyaluronic acid mixture (LuminoMarkTM) for Localization in Patients with Non-palpable Breast Lesions: A Multi-center Open-label Parallel Phase-2 Clinical trial

10.21203/rs.3.rs-24969/v3 ◽

2021 ◽

Author(s):

isaac kim ◽

Hee Jun Choi ◽

Jai Min Ryu ◽

Se Kyung Lee ◽

Jong Han Yu ◽

...

Keyword(s):

Clinical Trial ◽

Hyaluronic Acid ◽

Skin Pigmentation ◽

Test Group ◽

Acid Mixture ◽

Control Group ◽

Breast Lesions ◽

Efficacy And Safety ◽

Open Label ◽

Palpable Breast

Abstract Backgrounds With increasing screening for breast cancer, non-palpable breast lesions are detected more frequently. A preoperative localization is very important for a minimal but accurate excision of a non-palpable breast lesion. The purpose of this study was to evaluate the efficacy and safety of indocyanine green(ICG)-hyaluronic acid mixture injection as a novel material for localization. Methods We performed prospective clinical trial with female patients who underwent surgery for non-palpable breast lesion. All patients were sequentially assigned to the control group(localization with activated charcoal), test group 1(ICG-hyaluronic acid mixture 0.1ml), or test group 2(ICG-hyaluronic acid mixture 0.2ml) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (control group = 14, test 1 group = 15, test 2 group = 15 patients ). Among all patients, Fibroadenoma accounted for the largest share (38.6%, 17/44) and malignancy accounted for 11.4% (5/44). There was no difference in baseline characteristics in three groups. The marking rate was over 86% in all groups, and there was no difference. However, skin pigmentation was only in the control group and the accuracy of resection (the greatest length in cm of the excised specimen divided by the greatest length in cm on the pre-operation ultrasound image, the value closer to 1 meant resection as much as the size on ultrasound image) was different significantly. The average was 3.7 in control group and 2.2 in test 1 group and 2.1 in test 2 group. ( p-value was 0.037 between control and test 1 group, 0.744 between test 1 and test 2 group, 0.026 between control and test2 group respectively. ) Conclusion ICG-hyaluronic acid mixture injection is a new method for localization with non-palpable breast lesions, as well as a better method with higher accuracy of resection, lower skin pigmentation. Further research is required to apply this method to malignant breast lesions.Trial registration “A Multi-center Open-label Parallel Phase-2 Clinical trial to evaluate the efficacy and safety of LuminoMarkTM for Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259).

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A retrospective cohort study of how alveolar ridge preservation affects the need of alveolar ridge augmentation at posterior tooth implant sites

Clinical Oral Investigations ◽

10.1007/s00784-021-03778-y ◽

2021 ◽

Author(s):

Kai-Fang Hu ◽

Ying-Chu Lin ◽

Yu-Ting Huang ◽

Yu-Hsiang Chou

Keyword(s):

Treatment Modality ◽

Alveolar Bone ◽

Dental Treatment ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Ridge Augmentation ◽

Posterior Tooth ◽

Alveolar Ridge Preservation ◽

Study Results ◽

Treatment Plans

Abstract Objectives The aim of this study was to assess whether alveolar ridge preservation (ARP) can reduce the need of ridge augmentation at posterior tooth sites. Material and methods This study enrolled patients who received dental implants at posterior tooth sites during 2013–2019. Demographic data and dental treatment histories were collected. Based on healing patterns after tooth extraction, patients were divided into ARP and spontaneous healing (SH) groups. Three surgical treatment plans were devised according to the alveolar bone volume on cone-beam computed tomography (CBCT). The three treatment plans were to perform implant alone, simultaneous guided bone regeneration (GBR) and implantation, and staged GBR before implantation. Statistical analyses were performed to determine relationships. Results There were 92 implant records in the ARP group and 249 implant records in the SH group. A significant intergroup difference was observed regarding the frequency distribution of the treatment modality of staged GBR before implant (χ2 = 15.07, p = 0.0005). Based on the implant alone treatment modality and simple logistic regression, the SH pattern was related to staged GBR before implant (SH vs. ARP: crude odds ratio (OR) = 4.65, 95% confidence interval (CI) = 2.15–11.61, p = 0.0003). After adjusting confounding factors, the risk was still significant (adjusted OR = 5.02, 95% CI = 2.26–12.85, p = 0.0002). Conclusions The study results suggested that ARP is more likely to lead to the treatment modality of implant alone and reduce the need for staged GBR before implantation. Clinical relevance This study describes ARP capable of minimizing the need for staged GBR before implantation and shortening the treatment duration.

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A randomized, controlled, multicentre clinical trial of post‐extraction alveolar ridge preservation

Journal Of Clinical Periodontology ◽

10.1111/jcpe.12623 ◽

2016 ◽

Vol 43 (12) ◽

pp. 1188-1199 ◽

Cited By ~ 22

Author(s):

Eric Todd Scheyer ◽

Rick Heard ◽

Jim Janakievski ◽

George Mandelaris ◽

Marc L. Nevins ◽

...

Keyword(s):

Clinical Trial ◽

Ridge Preservation ◽

Alveolar Ridge ◽

Multicentre Clinical Trial ◽

Randomized Controlled ◽

Alveolar Ridge Preservation

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Bone dehiscence formation during orthodontic tooth movement through atrophic alveolar ridges

The Angle Orthodontist ◽

10.2319/063019-443.1 ◽

2019 ◽

Vol 90 (3) ◽

pp. 321-329

Author(s):

Adilson Luiz Ramos ◽

Monique Cimão dos Santos ◽

Márcio Rodrigues de Almeida ◽

Carlos Flores Mir

Keyword(s):

Null Hypothesis ◽

Alveolar Bone ◽

Tooth Movement ◽

Linear Regression Analysis ◽

Orthodontic Tooth Movement ◽

Wilcoxon Test ◽

Control Group ◽

Multivariate Linear Regression Analysis ◽

Alveolar Ridge ◽

Bone Height

ABSTRACT Objectives To test the null hypothesis that there is no difference in bone dehiscence formation before and after orthodontic tooth movement through an atrophic alveolar ridge. Material and Methods This longitudinal retrospective study evaluated pretreatment and posttreatment cone-beam computed tomography imaging of 15 adult patients. Twenty-five teeth were moved through the atrophic alveolar bone, whereas 25 teeth not subjected to translational movement were considered controls. The distances between the cementoenamel junction and the alveolar bone crest were assessed at the mesial, distal, buccal, and lingual surfaces of all of these teeth. Data were compared using the Wilcoxon test. The Spearman correlation test and multivariate linear regression analysis were also performed. Results In general, crestal bone height was reduced around 0.5 mm in all groups in every direction. Median buccal dehiscence increased significantly (+2.25 mm) (P < .05) in teeth moved through the atrophic ridge. Control teeth also had buccal crest loss (+0.83 mm), but this was not statistically different from that of the experimental teeth. Lingual dehiscence increased significantly for the experimental (+0.17 mm) and control (+0.65 mm) groups. Mesial bone height decreased more in the control group (–0.44mm) than in the experimental group (–0.14mm). There was moderate correlation between amount of tooth movement and alveolar bone loss. Conclusions The null hypothesis was rejected as dehiscence increased after tooth movement through an atrophic alveolar ridge, mainly in the buccal plate.

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