scholarly journals Safety and feasibility study of using polyphosphate (PolyP) in alveolar cleft repair: a pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Salem A. Alkaabi ◽  
Diandra Sabrina Natsir Kalla ◽  
Ghamdan A. Alsabri ◽  
Abul Fauzi ◽  
Nova Jansen ◽  
...  
Keyword(s):  
Pilot Study ◽  
Calcium Phosphate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
High Energy ◽  
Close Monitoring ◽  
Code Number ◽  
Alveolar Cleft ◽  
Safety Parameters

Abstract Background Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in the blood, primarily in platelets. PolyP plays a role as a phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs, alone or in combination with BCP, in a first-in-human clinical trial. Methods This single-blinded, parallel, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13–34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was 6 months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations. Osteoinductivity evaluation using histomorphometric analysis of biopsies was not possible due to COVID restrictions. Results Due to surgical and feasibility reasons, eventually, only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day 180). Three out of eight were unable to reach the hospital due to COVID-19 restrictions. One patient decided not to continue with the study. None of the patients showed any allergic reactions or any remarkable local or systematic side effects. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients who got the BCP/Ca-polyP MPs combination had scores ranging from I to III. Conclusions Our results indicate that Ca-polyP MPs and the BCP/Ca-polyP MPs combination appear to be safe graft materials; however, in the current setting, Ca-polyP MPs alone may not be a sufficiently stable defect-filling scaffold to be used in alveolar cleft repair. Trial registration Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019.

scholarly journals Safety and feasibility study of using Polyphosphate (PolyP) in alveolar cleft repair, A Pilot study.

2021 ◽  
Author(s):  
Salem Alkaabi ◽  
Natsir Kalla ◽  
Alsabri GA ◽  
A Fauzi ◽  
Jansen NA ◽  
...  
Keyword(s):  
Pilot Study ◽  
Calcium Phosphate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
High Energy ◽  
Close Monitoring ◽  
Code Number ◽  
Alveolar Cleft ◽  
Safety Parameters

Abstract Background: Bone grafting is an important surgical procedure to reconstruct alveolar bone defects in patients with cleft lip and palate. Polyphosphate (PolyP) is a physiological polymer present in blood, primarily in platelets. PolyP is playing a role as phosphate source in bone calcium phosphate deposition. Moreover, the cleavage of high-energy bonds to release phosphates provides local energy necessary for regenerative processes. In this study, polyP is complexed with calcium to form Calcium polyP microparticles (Ca-polyP MPs), which were shown to have osteoinductive properties in preclinical studies. The aim of this study was to evaluate the feasibility, safety and osteoinductivity of Ca-polyP MPs in-first human clinical trial.Methods: This single blinded, randomized, prospective clinical pilot study enrolled eight adolescent patients (mean age 18.1: range 13 - 34 years) with residual alveolar bone cleft. Randomization in two groups (four receiving Ca-polyP MPs only, four a combination of Ca-polyP MPs and biphasic calcium phosphate (BCP)) was performed. Patient follow-up was six months. Outcome parameters included safety parameters and close monitoring of possible adverse effects using radiographic imaging, regular blood tests, and physical examinations.Results: Due to surgical and technical reasons, eventually only 2 patients received Ca-polyP MPs, and the others the combination graft. All patients were assessed up to day 90. Four out of eight were able to continue with the final assessment day (day180). Three out eight were unable to reach the hospital due to Covid-19 restrictions. One patient decided not to continue with the study.No allergies or remarkable local or systematic reaction were noticed in all patients. Radiographically, patients receiving Ca-polyP MPs only were scored grade IV Bergland scale, while patients received combination Ca-polyP MPs and BCP were ranged from score I to III.Conclusions: Ca-polyP MPs and combination of Ca-polyP MPs/BCP are safe graft materials, however, Ca-polyP MPs alone are not sufficiently stable defect-filling scaffolds to be used in alveolar cleft repair.Trial registration: Indonesian Trial Registry under number INA-EW74C1N by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019

Polyphosphate (PolyP) for alveolar cleft repair, study protocol for a pilot randomized controlled trial.

2021 ◽  
Author(s):  
Salem Alkaabi ◽  
Diandra S Natsir Kalla ◽  
Abul Fauzi ◽  
Andi Tajrin ◽  
WEG Müller ◽  
...  
Keyword(s):  
Bone Formation ◽  
Cleft Lip ◽  
Controlled Trial ◽  
High Energy ◽  
Graft Material ◽  
Radiographic Imaging ◽  
Code Number ◽  
Alveolar Cleft ◽  
Cleft Lip Palate ◽  
Safety Parameters

Abstract Objective: Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of maxillary segments by inducing new bone formation, and in bilateral cleft cases also to stabilize the pre- maxilla. Polyphosphate (PolyP), a physiological polymer composed of orthophosphate units linked together with high-energy phosphate bonds, is a naturally existing compound in platelets which, when complexed with calcium as Ca-polyP microparticles (Ca-polyP MPs), was proven to have osteoinductive properties in preclinical studies. Aim: To evaluate the feasibility, safety and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in humans. Methods: This prospective non-blinded first-in-man clinical pilot study shall consist of 8 alveolar cleft patients of 13 years or older to evaluate the feasibility and safety of Ca-PolyP MPs as a bone-inducing graft material. Patients will receive Ca-polyP graft material only, or Ca-polyP in combination with biphasic calcium phosphate (BCP) as a bone substitute carrier. During the trial, the participants will be investigated closely for safety parameters using radiographic imaging, regular blood tests, and physical examinations. After 6 months, a hollow drill will be used to prepare the implantation site to obtain a biopsy. The radiographic imaging will be used for clinical evaluation; the biopsy will be processed for histological/histomorphometric evaluation of bone formation. Discussion: This is the first-in-man study evaluating the safety and feasibilty of the polyP as well as the potential regenerative capacity of polyP using an alveolar cleft model.Trial registration {31a} The clinical trial protocol received a written approval by the ethical committee of Faculty of Medicine, Hasanuddin University, Makassar, Indonesia with code number 1063/UN4.6.4.5.31/PP36/2019. On completion of the trial, the results on safety, feasibility and bone formation with polyP as graft material will published.

Transporte óseo alveolar intraoral en pacientes con hendiduras alveolares: serie de casos Intraoral alveolar bone transportation in alveolar cleft patients: case series

2018 ◽  
Vol 45 (4) ◽  
pp. 255-260
Author(s):  
Luis Gonzalez ◽  
Alberto Pedraza
Keyword(s):  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Average Distance ◽  
Case Series ◽  
Retrospective Case ◽  
Alveolar Cleft ◽  
Fixed Dental Prosthesis ◽  
Case Series Study ◽  
Bone Transportation

Introducción: El tratamiento de la hendidura alveolar, del paciente fisurado, permite un adecuado crecimiento facial. Los injertos óseos han sido el tratamiento ideal. Sin embargo la técnica de distracción osteogénica mediante transporte óseo alveolar intraoral ha demostrado ser muy predecible. Objetivo: Describir los resultados del cierre de la Hendidura alveolar, con la técnica de transporte óseo alveolar intraoral bifocal y trifocal en pacientes labio fisurados. Diseño: Estudio retrospectivo de serie de casos. Materiales y métodos: Fueron tratados 4 pacientes con hendidura alveolar unilateral, manejados con la técnica de transporte óseo alveolar intraoral bifocal y trifocal en el año 2008 al 2009, con un seguimiento hasta el año 2014. Todos los pacientes fueron tratados con un aparato Hyrax® (Dentaurum, Alemania) modificado. Resultados: El promedio de distancia del transporte óseo requerido fue de 9,75mm (rango de 15 mm a 9 mm). Se colocaron 5 implantes dentales rehabilitados con prótesis dental fija. Conclusión: El estudio de los casos clínicos demuestra una predictibilidadelevada así como un rango de éxito alto, en los individuos tratados conesta técnica. Por tal motivo el transporte óseo alveolar intraoral es una alternativa eficaz para el tratamiento de hendiduras alveolares extensas.Introduction: The management of alveolar cleft patients, allows an adequate facial growth in cleft lip and palate patients. Bone grafts have been the gold standard treatment. However, the technique of osteogenic distraction by intraoral alveolar bone transportation has proven to be highly predictable. Objective: To describe the results of alveolar cleft management with the intraoral bifocal and trifocal alveolar bone transportation technique in cleft palate patients. Design of study: Retrospective case series study. Materials and methods: 4 patients with unilateral alveolar cleft were treated with the bifocal and trifocal intraoral alveolar bone transportation technique from 2008 to 2009. The cases were followed up until 2014. All patients were treated with a modified Hyrax® (Dentaurum, Germany) device. Results: The average distance of bone transportation required was 9.75mm (range from 15mm to 9mm). 5 dental implants with fixed dental prosthesis were placed. Conclusion: Clinical cases study demonstrated a high predictability, as well as a high success ratein individuals treated with this technique. Therefore, intraoral alveolar bone transportation is an effective alternative for the management of extensive alveolar clefts.

The Presurgical Status of the Alveolar Cleft and Success of Secondary Bone Grafting

2000 ◽  
Vol 37 (2) ◽  
pp. 179-184 ◽  
Author(s):  
Catherine Aurouze ◽  
Karlind T. Moller ◽  
Richard R. Bevis ◽  
Kelly Rehm ◽  
Joel Rudney
Keyword(s):  
Healthy Individual ◽  
Bone Grafting ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Alveolar Cleft ◽  
Satisfactory Outcome ◽  
Alveolar Bone Grafting ◽  
Study Population ◽  
Secondary Alveolar Bone Grafting

Objective The primary purpose of this study was to evaluate presurgical status of the alveolar cleft site and success of secondary alveolar bone grafting. Design Thirty patient records were retrospectively reviewed. Patients selected for inclusion had isolated cleft of at least the primary palate. Patients with additional anomalies were not selected. The study population consisted of 15 female sites and 16 male cleft sites. There were two bilateral cleft lip and palate (CLP) patients and 28 unilateral CLP patients. The age at the time of the secondary alveolar bone grafting ranged from 7 years to 14 years, 4 months. Setting The study was conducted at the Cleft Palate Clinic at the University of Minnesota, School of Dentistry. Method Presurgical radiographs taken at least 1 month prior to the secondary bone grafting and postsurgical radiographs taken at least 6 months after bone surgery were measured. Measurements included size of the cleft defect and bone support for distal and mesial teeth adjacent to the cleft. Evaluation of success was determined on the basis of postsurgical measurements of satisfactory, intermediate, and unsatisfactory outcomes. Results and Conclusion The size of the cleft defect was not correlated with the success rate of the secondary alveolar bone grafting. If the amount of distal bone support for the mesial tooth was the same as those in a periodontally healthy individual, a satisfactory outcome was 5.8 times more likely. If the amount of mesial bone support for the distal tooth was the same as those in a periodontally healthy individual, the satisfactory outcome was 3.8 times more likely. Although not a primary purpose of the study, it was found that in this study population, if the patient was female, a satisfactory outcome was 3.8 times more likely.

Segment Distraction to Reduce a Wide Alveolar Cleft before Alveolar Bone Grafting

2003 ◽  
Vol 40 (6) ◽  
pp. 561-565 ◽  
Author(s):  
Thomas Binger ◽  
Christos Katsaros ◽  
Martin Rücker ◽  
Wolfgang J. Spitzer
Keyword(s):  
Soft Tissue ◽  
Bone Grafting ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Soft Tissue Coverage ◽  
Alveolar Cleft ◽  
Attached Gingiva ◽  
Alveolar Bone Grafting ◽  
Keratinized Mucosa

Objective To demonstrate a method for reduction of wide alveolar clefts prior to bone grafting. This method aims to facilitate bone grafting and achieve adequate soft tissue coverage of the graft with attached gingiva. Case Report Treatment of a patient with bilateral cleft lip and palate with a severe alveolar defect on the left side is illustrated. Distraction osteogenesis was used to mesialize the left segment so that the alveolar cleft was reduced to a minimum. After a 10-week retention period, bone grafting of the reduced alveolar defect was successfully performed. After consolidation of the bone graft, the alveolar cleft was found to have an osseous closure with adequate soft tissue coverage. Conclusion In patients with a wide alveolar cleft, soft tissue coverage with keratinized mucosa can be more readily assured by reducing the alveolar cleft by callus distraction to mesialize the lateral segment prior to bone grafting.

scholarly journals Polyphosphate (PolyP) for alveolar cleft repair: study protocol for a pilot randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
S. A. Alkaabi ◽  
D. S. Natsir Kalla ◽  
G. A. Alsabri ◽  
A. Fauzi ◽  
A. Tajrin ◽  
...  
Keyword(s):  
Bone Formation ◽  
Cleft Lip ◽  
Controlled Trial ◽  
High Energy ◽  
Graft Material ◽  
Radiographic Imaging ◽  
Alveolar Cleft ◽  
Cleft Lip Palate ◽  
Safety Parameters ◽  
Physical Examinations

Abstract Objective Bone grafting is an important surgical procedure to restore missing bone in patients with alveolar cleft lip/palate, aiming to stabilize either sides of the maxillary segments by inducing new bone formation, and in bilateral cleft cases also to stabilize the pre-maxilla. Polyphosphate (PolyP), a physiological polymer composed of orthophosphate units linked together with high-energy phosphate bonds, is a naturally existing compound in platelets which, when complexed with calcium as Ca-polyP microparticles (Ca-polyP MPs), was proven to have osteoinductive properties in preclinical studies. Aim To evaluate the feasibility, safety, and osteoinductivity of Ca-polyP MPs as a bone-inducing graft material in humans. Methods This prospective non-blinded first-in-man clinical pilot study shall consist of 8 alveolar cleft patients of 13 years or older to evaluate the feasibility and safety of Ca-PolyP MPs as a bone-inducing graft material. Patients will receive Ca-polyP graft material only or Ca-polyP in combination with biphasic calcium phosphate (BCP) as a bone substitute carrier. During the trial, the participants will be investigated closely for safety parameters using radiographic imaging, regular blood tests, and physical examinations. After 6 months, a hollow drill will be used to prepare the implantation site to obtain a biopsy. The radiographic imaging will be used for clinical evaluation; the biopsy will be processed for histological/histomorphometric evaluation of bone formation. Discussion This is the first-in-man study evaluating the safety and feasibility of the polyP as well as the potential regenerative capacity of polyP using an alveolar cleft model. Trial registration Indonesian Trial Registry INA-EW74C1N. Registered on 12 June 2020

Micro-structured Beta-Tricalcium Phosphate for Repair of the Alveolar Cleft in Cleft Lip and Palate Patients: A Pilot Study

2015 ◽  
Vol 52 (3) ◽  
pp. 336-340 ◽  
Author(s):  
Ad De Ruiter ◽  
Nard Janssen ◽  
Robert Van Es ◽  
Michael Frank ◽  
Gert Meijer ◽  
...  
Keyword(s):  
Pilot Study ◽  
Tricalcium Phosphate ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Cleft ◽  
Beta Tricalcium Phosphate

scholarly journals Orthognathic Surgery Combined with Orthodontic Treatment in a Patient with Bilateral Cleft Lip, Palate and Alveolus, Without Alveolar Bone Graft: A Case Report

2021 ◽  
Vol 3 (1) ◽  
pp. 1
Author(s):  
Yudi Siswanto ◽  
Magda Rosalina Hutagalung ◽  
Indri Lakhsmi Putri ◽  
Jusuf Sjamsudin
Keyword(s):  
Bone Graft ◽  
Orthognathic Surgery ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Maxillary Hypoplasia ◽  
Le Fort ◽  
Alveolar Cleft ◽  
Bilateral Cleft Lip ◽  
Cleft Lip Palate

Background: The incidence of cleft lip and palate is 8 in every 10,000 live births. A patient with this condition experiences a deficiency in maxillary growth. Maxillary hypoplasia leads to malocclusion and skeletal disharmony. Orthognathic surgery at skeletal maturity is the standard procedure at the end of the protocol to correct maxillary hypoplasia resulting in malocclusion not correctable with orthodontics alone.Case Presentation and Operation Technique: We report the result of orthognathic surgery performed on a 23 year old male with complete bilateral cleft lip, palate, and alveolus. We proceeded with bimaxillary surgery despite the alveolar cleft. We also recorded a neglected alveolar cleft in which he should have had undergone alveolar bone graft prior to the current procedure. The pre-maxillary segment was stabilized with miniplate followed by Le Fort 1 advancement and mandibular setback guided by an occlusal wafer. Malar augmentation was done by onlay bone grafts. Mandibulo-maxillary fixation was maintained. Postoperatively, a good occlusion and better facial harmony were achieved. He was planned to undergo a septorhinoplasty in the near future.Discussion: Despite adequate treatments following the protocol recommended by many centres, some patients developed some degree of maxillary hypoplasia. A quarter of this population need osteotomies and Le Fort I maxillary osteotomy is the most common procedure to correct retrognathic maxilla.Conclusion: Orthognathic surgery combined with orthodontic treatment in a patient with bilateral cleft lip and palate provided good functional and aesthetic result. However, this procedure cannot replace the standard protocol of having an alveolar bone graft performed before permanent canine eruption to achieve optimal outcomes

Preliminary Report of Two-Stage Secondary Alveolar Bone Grafting for Patients with Bilateral Cleft Lip and Palate

2003 ◽  
Vol 40 (5) ◽  
pp. 449-452 ◽  
Author(s):  
S. Kamakura ◽  
T. Yamaguchi ◽  
S. Kochi ◽  
A. Sato ◽  
K. Motegi
Keyword(s):  
Bone Grafting ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Contralateral Side ◽  
Two Stage ◽  
Alveolar Cleft ◽  
Alveolar Bone Grafting ◽  
Bilateral Cleft Lip ◽  
Secondary Alveolar Bone Grafting

Objective To overcome the difficulties of one-stage secondary alveolar bone grafting for patients with bilateral cleft lip and palate (BCLP) who have a broad alveolar cleft, the value of two-stage alveolar bone grafting was examined. Patients Three patients (2 girls and 1 boy) with BCLP were treated by two-stage alveolar bone grafting. The procedure consisted of a first-stage surgery (mean age 8 year 6 months ± 7.8 months), which consisted of alveolar bone grafting for one side of the BCLP, and second-stage surgery for the contralateral side several months later. For the postoperative assessment, radiographs of the operated site were examined. Results The average amount of implanted bone per operation and per patient was 6.8 ± 1.1 g and 13.7 ± 1.0 g, respectively. Postoperative clinical and radiographic examinations revealed that an appreciable alveolar bone ridge had formed, and there were no major complications. Conclusions Two-stage alveolar bone grafting, which makes it possible to reduce the amount of implanted bone, could be an optional surgical procedure for patients with BCLP and a broad alveolar cleft.

scholarly journals Comparative Volume Analysis of Alveolar Defects by 3D Simulation

2019 ◽  
Vol 8 (9) ◽  
pp. 1401 ◽  
Author(s):  
Pang-Yun Chou ◽  
Rafael Denadai ◽  
Rami R. Hallac ◽  
Sarayuth Dumrongwongsiri ◽  
Wei-Chuan Hsieh ◽  
...  
Keyword(s):  
Bone Graft ◽  
Cleft Lip ◽  
Cleft Lip And Palate ◽  
Alveolar Bone ◽  
Surgical Simulation ◽  
Intraclass Correlation ◽  
Simulation Methods ◽  
Alveolar Cleft ◽  
Surgical Method ◽  
Volumetric Assessment

A precise volumetric assessment of maxillary alveolar defects in patients with cleft lip and palate can reduce donor site morbidity or allow accurate preparation of bone substitutes in future applications. However, there is a lack of agreement regarding the optimal volumetric technique to adopt. This study measured the alveolar bone defects by using two cone-beam computed tomography (CBCT)-based surgical simulation methods. Presurgical CBCT scans from 32 patients with unilateral or bilateral clefts undergoing alveolar bone graft surgery were analyzed. Two hands-on CBCT-based volumetric measurement methods were compared: the 3D real-scale printed model-based surgical method and the virtual surgical method. Different densities of CBCT were compared. Intra- and inter-examiner reliability was assessed. For patients with unilateral clefts, the average alveolar defect volumes were 1.09 ± 0.24 and 1.09 ± 0.25 mL (p > 0.05) for 3D printing- and virtual-based models, respectively; for patients with bilateral clefts, they were 2.05 ± 0.22 and 2.02 ± 0.27 mL (p > 0.05), respectively. Bland–Altman analysis revealed that the methods were equivalent for unilateral and bilateral alveolar cleft defect assessment. No significant differences or linear relationships were observed between adjacent different densities of CBCT for model production to obtain the measured volumes. Intra- and inter-examiner reliability was moderate to good (intraclass correlation coefficient (ICC) > 0.6) for all measurements. This study revealed that the volume of unilateral and bilateral alveolar cleft defects can be equally quantified by 3D-printed and virtual surgical simulation methods and provides alveolar defect-specific volumes which can serve as a reference for planning and execution of alveolar bone graft surgery.

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