Ad de Ruiter1, Eric Dik2, Robert van Es2, Andries van der Bilt2, Nard Janssen2, Gert Meijer3, Ron Koole2, Antoine Rosenberg2. 1. Department of Oral and Maxillofacial Surgery, (Head: Prof. Dr. R. Koole), University Medical Centre Utrecht, Heidelberglaan 100, G.05.129, PO Box 85500, NL 3508 GA Utrecht, The Netherlands. Electronic address: a.p.deruiter@umcutrecht.nl. 2. Department of Oral and Maxillofacial Surgery, (Head: Prof. Dr. R. Koole), University Medical Centre Utrecht, Heidelberglaan 100, G.05.129, PO Box 85500, NL 3508 GA Utrecht, The Netherlands. 3. Department of Oral and Maxillofacial Surgery, Department of Implantology and Periodontology, Radboud University Nijmegen Medical Centre, PO Box 9101, NL 6500 HB Nijmegen, The Netherlands.
Abstract
OBJECTIVES: The purpose of this study was to evaluate the use of synthetic bone graft material as a filling material at the mandibular symphysis donor site of autologous bone in children. MATERIALS AND METHODS: A blinded patient group comprised 20 patients withunilateral (UCLP) or bilateral (BCLP) cleft of lip and palate, all with an indication for alveolar cleft repair. The study took the form of a prospective randomized clinical trial. We used lateral cephalograms for the measurement of the symphyseal donor area defect both peroperatively and at 12 months postoperatively. The data obtained were digitalized and the treatment outcome expressed in numbers. Comparisons with a previous study were made. Histology of biopsies and CT scans were used for visualising bone formation. RESULTS: This study demonstrates that the micro-structured, resorbable calcium phosphate ceramic provides good regeneration properties for the repair of a critical size bony defect in children. One year postoperatively, the measurements taken from lateral cephalograms show that there is scarcely any visible residual defect. Histological investigations of the bone biopsies show solid, induced bone formation and almost complete resorption of the micro-structured calcium phosphate. CONCLUSIONS: The findings of this study (novel in children) indicate that micro-structured resorbable calcium phosphate is an excellent alternative to autologous bone. The digital findings showed a restored donor site defect significantly indicating the efficacy (i.e., osteoconductivity and resorbability) of this bone substitute. The biopsy histology demonstrated the overall presence of newly formed vital bone and the resorption of the bone substitute. Its use for grafting the alveolar cleft is currently researched and it may become the new standard. CLINICAL RELEVANCE: As co-morbidity and prolonged operation time at the donor operation site are inherent to the alveolar cleft repair procedure, the use of the described bone substitute is winning progress.
RCT Entities:
OBJECTIVES: The purpose of this study was to evaluate the use of synthetic bone graft material as a filling material at the mandibular symphysis donor site of autologous bone in children. MATERIALS AND METHODS: A blinded patient group comprised 20 patients with unilateral (UCLP) or bilateral (BCLP) cleft of lip and palate, all with an indication for alveolar cleft repair. The study took the form of a prospective randomized clinical trial. We used lateral cephalograms for the measurement of the symphyseal donor area defect both peroperatively and at 12 months postoperatively. The data obtained were digitalized and the treatment outcome expressed in numbers. Comparisons with a previous study were made. Histology of biopsies and CT scans were used for visualising bone formation. RESULTS: This study demonstrates that the micro-structured, resorbable calcium phosphate ceramic provides good regeneration properties for the repair of a critical size bony defect in children. One year postoperatively, the measurements taken from lateral cephalograms show that there is scarcely any visible residual defect. Histological investigations of the bone biopsies show solid, induced bone formation and almost complete resorption of the micro-structured calcium phosphate. CONCLUSIONS: The findings of this study (novel in children) indicate that micro-structured resorbable calcium phosphate is an excellent alternative to autologous bone. The digital findings showed a restored donor site defect significantly indicating the efficacy (i.e., osteoconductivity and resorbability) of this bone substitute. The biopsy histology demonstrated the overall presence of newly formed vital bone and the resorption of the bone substitute. Its use for grafting the alveolar cleft is currently researched and it may become the new standard. CLINICAL RELEVANCE: As co-morbidity and prolonged operation time at the donor operation site are inherent to the alveolar cleft repair procedure, the use of the described bone substitute is winning progress.
Authors: S A Alkaabi; D S Natsir Kalla; G A Alsabri; A Fauzi; A Tajrin; W E G Müller; H C Schröder; X G Wang; T Forouzanfar; M N Helder; M Ruslin Journal: Trials Date: 2021-06-14 Impact factor: 2.279