Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial

<i>Background and Objectives</i>: Maxillary bone defects related to post-extraction alveolar ridge resorption are usual. These defects may lead to failure in further surgical implant phases given the lack of bone volume to perform the dental implant. The objective of this clinical assay...

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Main Authors: Javier Flores Fraile, Nansi López-Valverde, Arcadio García de Castro Andews, Juan Antonio Santos Marino, Juan M. Ramírez, Rafael Gómez de Diego, Javier Montero, Antonio López-Valverde, Leticia Alejandra Blanco Antona
Format: Article
Language:English
Published: MDPI AG 2020-01-01
Series:Medicina
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Online Access:https://www.mdpi.com/1010-660X/56/2/46
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author Javier Flores Fraile
Nansi López-Valverde
Arcadio García de Castro Andews
Juan Antonio Santos Marino
Juan M. Ramírez
Rafael Gómez de Diego
Javier Montero
Antonio López-Valverde
Leticia Alejandra Blanco Antona
author_facet Javier Flores Fraile
Nansi López-Valverde
Arcadio García de Castro Andews
Juan Antonio Santos Marino
Juan M. Ramírez
Rafael Gómez de Diego
Javier Montero
Antonio López-Valverde
Leticia Alejandra Blanco Antona
author_sort Javier Flores Fraile
collection DOAJ
description <i>Background and Objectives</i>: Maxillary bone defects related to post-extraction alveolar ridge resorption are usual. These defects may lead to failure in further surgical implant phases given the lack of bone volume to perform the dental implant. The objective of this clinical assay was to evaluate the safety and efficacy of an experimental synthetic bone substitute in the preservation of post-extraction maxillary alveoli. <i>Materials and Methods</i>: 33 voluntary patients who had at least one maxillary premolar tooth that was a candidate for exodontia (<i>n</i> = 39) and subsequent implant rehabilitation participated. The regenerated alveoli were monitored by means of periodic clinical examinations (days 9 &#177; 1, 21 &#177; 4, 42 &#177; 6, and 84 &#177; 6), measuring the height and width of the alveolar crest (days 0 and 180 &#177; 5), measurement of radiodensity using tomographic techniques (days 0&#8722;5 and 175 &#177; 5), and histological examination of biopsies collected at 180 &#177; 5 days. <i>Results</i>: No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied. A variation in width of &#8722;0.9 &#177; 1.3 mm and &#8722;0.6 &#177; 1.5 mm, and a variation in height of &#8722;0.1 &#177; 0.9 mm and &#8722;0.3 &#177; 0.7 mm was observed for experimental material Sil-Oss<sup>&#174;</sup> and Bio-Oss<sup>&#174;</sup>, respectively. The radiodensity of the alveoli regenerated with the experimental material was significantly lower than that corresponding to Bio-Oss<sup>&#174;</sup>. However, the histological study showed greater osteoid matrix and replacement of the material with newformed bone in the implanted beds with the experimental material. <i>Conclusions:</i> Both materials can be used safely and proved equally effective in maintaining alveolar flange dimensions, they are also histologically biocompatible, bioactive and osteoconductive. The experimental material showed the advantage of being resorbable and replaced with newformed bone, in addition to promoting bone regeneration.
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spelling doaj.art-c712324d36d7453fbf359c9eb838f3b32023-09-02T03:26:22ZengMDPI AGMedicina1010-660X2020-01-015624610.3390/medicina56020046medicina56020046Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic TrialJavier Flores Fraile0Nansi López-Valverde1Arcadio García de Castro Andews2Juan Antonio Santos Marino3Juan M. Ramírez4Rafael Gómez de Diego5Javier Montero6Antonio López-Valverde7Leticia Alejandra Blanco Antona8Department of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, SpainDepartment of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, SpainScience to Business Foundation, 28760 Madrid, SpainDepartment of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, SpainDepartment of Morphological Sciences, University of Cordoba, 14071 Cordoba, SpainDepartment of Oral Medicine, Rey Juan Carlos University, 28922 Madrid, SpainDepartment of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, SpainDepartment of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, SpainDepartment of Surgery, University of Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), 37007 Salamanca, Spain<i>Background and Objectives</i>: Maxillary bone defects related to post-extraction alveolar ridge resorption are usual. These defects may lead to failure in further surgical implant phases given the lack of bone volume to perform the dental implant. The objective of this clinical assay was to evaluate the safety and efficacy of an experimental synthetic bone substitute in the preservation of post-extraction maxillary alveoli. <i>Materials and Methods</i>: 33 voluntary patients who had at least one maxillary premolar tooth that was a candidate for exodontia (<i>n</i> = 39) and subsequent implant rehabilitation participated. The regenerated alveoli were monitored by means of periodic clinical examinations (days 9 &#177; 1, 21 &#177; 4, 42 &#177; 6, and 84 &#177; 6), measuring the height and width of the alveolar crest (days 0 and 180 &#177; 5), measurement of radiodensity using tomographic techniques (days 0&#8722;5 and 175 &#177; 5), and histological examination of biopsies collected at 180 &#177; 5 days. <i>Results</i>: No significant differences were observed during the entire follow-up period between the two groups with respect to the safety variables studied. A variation in width of &#8722;0.9 &#177; 1.3 mm and &#8722;0.6 &#177; 1.5 mm, and a variation in height of &#8722;0.1 &#177; 0.9 mm and &#8722;0.3 &#177; 0.7 mm was observed for experimental material Sil-Oss<sup>&#174;</sup> and Bio-Oss<sup>&#174;</sup>, respectively. The radiodensity of the alveoli regenerated with the experimental material was significantly lower than that corresponding to Bio-Oss<sup>&#174;</sup>. However, the histological study showed greater osteoid matrix and replacement of the material with newformed bone in the implanted beds with the experimental material. <i>Conclusions:</i> Both materials can be used safely and proved equally effective in maintaining alveolar flange dimensions, they are also histologically biocompatible, bioactive and osteoconductive. The experimental material showed the advantage of being resorbable and replaced with newformed bone, in addition to promoting bone regeneration.https://www.mdpi.com/1010-660X/56/2/46bone substitutepost-extraction socketalveolar preservationcontrolled clinical trial
spellingShingle Javier Flores Fraile
Nansi López-Valverde
Arcadio García de Castro Andews
Juan Antonio Santos Marino
Juan M. Ramírez
Rafael Gómez de Diego
Javier Montero
Antonio López-Valverde
Leticia Alejandra Blanco Antona
Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
Medicina
bone substitute
post-extraction socket
alveolar preservation
controlled clinical trial
title Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
title_full Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
title_fullStr Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
title_full_unstemmed Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
title_short Safety and Efficacy of a New Synthetic Material Based on Monetite, Silica Gel, PS-Wallastonite, and a Hydroxyapatite Calcium Deficient: A Randomized Comparative Clinic Trial
title_sort safety and efficacy of a new synthetic material based on monetite silica gel ps wallastonite and a hydroxyapatite calcium deficient a randomized comparative clinic trial
topic bone substitute
post-extraction socket
alveolar preservation
controlled clinical trial
url https://www.mdpi.com/1010-660X/56/2/46
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