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CC BY 4.0 · Eur J Dent 2023; 17(03): 727-734
DOI: 10.1055/s-0042-1753453
Original Article

Prospective Clinical Study with New Materials for Tissue Regeneration: A Study in Humans

Authors

  • Nathalie Jeannette Kollek 

    1   Department of Implant Dentistry, International Dental Research Institute, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain

  • Carlos Pérez-Albacete Martínez 

    2   Department of Integrated Clinic for Adults, International Dental Research Institute, Catholic University San Antonio of Murcia, Murcia, Spain

  • José Manuel Granero Marín

    3   Department of Restorative Dentistry, International Dental Research Institute, Catholic University San Antonio of Murcia (UCAM), Murcia, Spain

  • José Eduardo Maté Sánchez de Val 

    4   Department of Implant Dentistry and Periodontology, International Dental Research Institute, Catholic University San Antonio of Murcia, Murcia, Spain
    5   Department of Materials Science and Engineering, International Research Institute for Biomaterials, Catholic University San Antonio of Murcia, Murcia, Spain
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Abstract

Objective This study was performed to evaluate the clinical, radiographic, and histomorphometric outcomes of novel bone grafting materials and dental membranes and to compare the results with current data from the literature.

Materials and Methods New synthetic bone substitutes, consisting of biphasic calcium phosphate in the ratio of 60% hydroxyapatite and 40% β-tricalcium phosphate, were applied in bony defects and covered by either a novel synthetic poly(lactic-co-glycolic) acid (PLGA) or porcine collagen membrane. A sample of 51 biomaterials was placed in a total of 20 patients during different surgical protocols. Implants were simultaneously inserted, and in the case of sinus floor elevations 6 months later. Pre- and postoperative cone-beam computed tomographies were taken. Bone biopsies were harvested from augmented sides and processed for histomorphometric evaluation.

Statistical Analysis Averages and ranges were calculated for the percentage of newly formed bone, residual biomaterial, and connective tissue. Data were submitted to analyze the radiological mean differences in length, width, and density. Paired t-tests were deployed for the analysis of differences within each group between the baseline (preoperative) and the final (postoperative) measurements.

Results The mean bone gain in length and width were 0.96 ± 3.33 mm (+27.59%) and 1.22 ± 1.87 mm (+30.48%), respectively. The bone density was increased by a factor of 4, reaching an average of 387.47 ± 328.86 HU. Histomorphometric evaluations revealed new bone formation of 41.44 ± 5.37%, residual biomaterial of 24.91 ± 7.31%, and connective tissue of 33.64 ± 4.81%. The mean healing period was 8.32 ± 3.00 months.

Conclusions Data from this study confirmed the suitability of the tested materials in dental surgery. The biomaterials may be recommended for various clinical procedures. A satisfactory level of increase of new bone was reported in augmented sides. No significant differences were observed between the tested membranes. PLGA membranes might be superior to collagen membranes for their easier handling.

Keywords

bone graft substitute - calcium phosphate - biomaterials - PLGA membrane - collagen membrane - osteointegration

Ethical Approval

The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Ethics Committee of the Catholic University San Antonio of Murcia (protocol code CE061912 and date of approval: 07.06.2019).


Authors' Contributions

All authors gave their final approval and agreed to be accountable for all aspects of the work.




Publication History

Article published online:
04 October 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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