Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749953
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-01-21
Brief Title:
Maxillary Sinus Floor Augmentation With Different Grafting Materials
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Maxillary Sinus Floor Augmentation With Autogenous Bone Graft Alone or in Combination With Symbios Biphasic Bone Graft Material or Symbios Xenograft Granules A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Implant placement in the posterior maxilla is compromised due to atrophy of the alveolar process and maxillary sinus pneumatisation Bone augmentation is frequently necessary before or in conjunction with implant placement The most commonly used method to augment the posterior maxillary involves maxillary sinus floor augmentation MSFA with autogenous bone graft or bone substitute Autogenous bone graft harvesting is associated with risk of donor site morbidity and unpredictable resorption of graft Thus bone substitutes alone or in combination with autogenous bone are used increasingly to simplify the surgical procedure
Symbios biphasic biomaterial is a resorbable inorganic bone forming material derived from red algae consisting of 20 hydroxylapatite and 80 β-tricalciumphosphate with osteoconductive properties Histologic and radiographic examinations indicate that β-tricalciumphosphate is slowly resorbed and replaced with bone MSFA with β-tricalciumphosphate alone or in combination with autogenous bone or other bone substitutes have demonstrated high implant survival and new bone
Symbios xenograft granules is a porcine bone mineral with osteoconductive properties Histologic and radiographic examinations indicate that xenograft is a non-resorbable graft material MSFA with xenograft alone or in combination with autogenous bone have shown high implant survival and new bone
The objective is to test the H0-hypothesis of no difference in implant outcome after MSFA with autogenous bone graft or in combination with Symbios biphasic biomaterial or Symbios xenograft 60 consecutively healthy patients with a missing posterior maxillary toothteeth will be randomly allocated to 1 MSFA with autogenous bone graft 2 MSFA with mixture of 50 autogenous bone graft and 50 Symbios biphasic biomaterial 3 MSFA with mixture of 50 autogenous bone graft and 50 Symbios xenograft Implants will be inserted simultaneously with MSFA Clinical andor radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography will be performed preoperatively immediate postoperatively before abutment connection after prosthetic rehabilitation and after one year to assess the treatment outcome and volumetric changes of the augmented area Outcome include survival of suprastructures and implants volumetric stability of graft peri-implant marginal bone level oral health related quality of life and complications
Symbios biphasic biomaterial is a resorbable inorganic bone forming material derived from red algae consisting of 20 hydroxylapatite and 80 β-tricalciumphosphate with osteoconductive properties Histologic and radiographic examinations indicate that β-tricalciumphosphate is slowly resorbed and replaced with bone MSFA with β-tricalciumphosphate alone or in combination with autogenous bone or other bone substitutes have demonstrated high implant survival and new bone
Symbios xenograft granules is a porcine bone mineral with osteoconductive properties Histologic and radiographic examinations indicate that xenograft is a non-resorbable graft material MSFA with xenograft alone or in combination with autogenous bone have shown high implant survival and new bone
The objective is to test the H0-hypothesis of no difference in implant outcome after MSFA with autogenous bone graft or in combination with Symbios biphasic biomaterial or Symbios xenograft 60 consecutively healthy patients with a missing posterior maxillary toothteeth will be randomly allocated to 1 MSFA with autogenous bone graft 2 MSFA with mixture of 50 autogenous bone graft and 50 Symbios biphasic biomaterial 3 MSFA with mixture of 50 autogenous bone graft and 50 Symbios xenograft Implants will be inserted simultaneously with MSFA Clinical andor radiographical evaluation using periapical radiographs and Cone Beam Computer Tomography will be performed preoperatively immediate postoperatively before abutment connection after prosthetic rehabilitation and after one year to assess the treatment outcome and volumetric changes of the augmented area Outcome include survival of suprastructures and implants volumetric stability of graft peri-implant marginal bone level oral health related quality of life and complications
Detailed Description:
Maxillary sinus floor augmentation MSFA is the most frequently used method to enhance the alveolar bone of the posterior maxilla before or in conjunction with implant placement Autogenous bone is considered as the preferred graft material due to its osteoinductive osteogenic and osteoconductive characteristics However autogenous bone grafts is associated with risk of donor site morbidity and unpredictable graft resorption Hence various bone substitutes are used increasingly to simplify the surgical procedure by diminishing the need for bone harvesting From a clinical and patient perspective it would be an advantage if autogenous bone grafts could partially or totally be replaced with bone substitutes
Symbios xenograft is a new porcine bone mineral characterized as an anorganic bone matrix with an interconnecting macro- and microscopic pore structure that supports formation and in-growth of new bone Porcine xenograft have previously been used for various augmentation procedures disclosing new bone formation Studies comparing autogenous bone graft with porcine bone alone or a mixture of autogenous bone and porcine bone have demonstrated high implant survival and new bone
Synthetic biomaterials including calcium phosphate calcium sulphate polymers and bioactive glass represent a large group of inorganic diverse biomaterials with variating structures chemical composition and physical properties Symbios biphasic biomaterials is a resorbable inorganic bone forming material derived from red algae consisting of 20 hydroxylapatite and 80 β-tricalciumphosphate Studies assessing MSFA with β-tricalciumphosphate have demonstrated that it is a safe grafting material with osteoconductive properties Histologic and radiographic examinations indicate that β-tricalciumphosphate is slowly resorbed and replaced with bone MSFA with β-tricalciumphosphate alone or in combination with autogenous bone or other bone substitutes have demonstrated high implant survival and new bone
The study purpose is to increase our knowledge about MSFA with autogenous bone alone or in combination with Symbios biphasic biomaterials or Symbios xenograft granules and to simplified the procedure Evaluation will include survival of suprastructures and implants peri-implant marginal bone level volumetrical stability of the graft and complications after an observation period of one year Furthermore oral health related quality of life using OHIP-14 self-administrated and patient satisfaction using visual analogue scales VAS will be evaluated
The objective is to test the H0 hypothesis of no differences in 1 Survival of suprastructures and implants 2 Volumetrical stability of the graft 3Peri-implant marginal bone level 4 Implantat stability quotient 5 Patient-reported outcome measures and 6 Biologic and technical complications
Materials and methods Study population 60 consecutively healthy patients with a missing posterior maxillary tooth will be included and randomly allocated to 1 MSFA with autogenous bone graft alone control group 2 mixture of 50 autogenous bone graft and 50 Symbios biphasic biomaterial test group I and 3 mixture of 50 autogenous bone and 50 Symbios xenograft test group II The study will be conducted at the Departments of Oral and Maxillofacial Surgery Aalborg University Hospital Denmark and Oral and Maxillofacial Surgery and Oral Medicine Malmö University Malmö Sweden
Patients will be included to the study by using a Facebook posting through the Universitys Facebook page the local dental association website or patients that are referred to the Departments for treatment of one or more missing teeth in the posterior maxilla All patients will be offered participation in the study if they meet the inclusion criteria Prior to patients first visit they will receive a notice informing about their rights and informed consent form will be signed
Inclusion criteria involves 1 20 years 2 Missing one or more posterior maxillary teeth 3 Residual bone height of the maxillary alveolar process between 3 to 7 mm 4 Width of the alveolar process 65 mm and 5 Mandibular occluding teeth Exclusion criteria involves 1 Contraindications to implant therapy 2 Full mouth plaque score 25 3 Progressive marginal periodontitis 4 Acute infection in the area intended for implant placement 5Parafunction bruxism or clenching 6 Psychiatric problems or unrealistic expectations 7 Heavy tobacco use define as 10 cigarettes per day and 8Pregnancy
The study is approved by the local ethical Committee on Health Research and the Danish Data Protection Agency and The Ethical Review Board in Lund Sweden and will be performed according to the Declaration of Helsinki on clinical research All patients will be given verbal and written information about the study at a clinical visit prior to surgery Written informed consent is mandatory for inclusion in the study and will be obtained by the investigators
The initial examination of the patient will include 1 Clinical examination and screening of the parodontal health 2 Radiographical examination of the residual alveolar bone height based on CBCT and Orthopantomography and 3 Patient will fill out the OHIP-14 questionnaire
The surgical procedure will be performed in local anesthesia Implant installation and fabrication of the subsequently prosthetic solution will be performed according to manufacturers recommendations The maxillary sinus wall is exposed by an intraoral marginal incision from tuber maxillae to the first premolar with a vertical releasing incision A 1 x 1 cm window to the maxillary sinus is created with metal and diamond burrs maintaining an intact Schneiderian membrane The Schneiderian membrane is elevated from the sinus floor as well as the lateral sinus wall and displaced dorsocranially with blunt dissector An implant bed is successively prepared on the top of the alveolar crest following manufactorys recommendations at 1500 rpm A straight implant ASTRA TECH Implant System EV 36 42 or 48 13 mm is inserted with a cover screw The implant stability quotient is measured for all inserted implants A sealed randomization envelope is opened in order to allocate the patient to 1 MSFA with particulated autogenous bone graft alone control group 2 a mixture of 50 particulated autogenous bone graft and 50 Symbios biphasic bone graft material 10 mm to 20 mm test group I 3 a mixture of 50 particulated autogenous bone graft and 50 Symbios xenograft granules 10 mm to 20 mm test group II The autogenous bone graft is harvested with a curved SafeScraper from the zygomatic buttress area Specially prepared stainless steel cups 05 cm3 and 1 cm3 are used to estimate 1 cm3 of graft material for each inserted implant The graft material will be soaked in autogenous blood from the surgical site until use The sinus around the implant is packed with 1 cm3 graft material The created window to the maxillary sinus is covered by a Symbios Collagen Membrane 15 x 20 mm Periosteum and mucosa are sutured with Vicryl 4-0 Minor perforations of sinus membrane will be covered with a Symbios Collagen Membrane If the sinus membrane is largely perforated the procedure will be cancelled and the patient will be withdrawn from the study No provisional restoration is inserted during the healing period After six months of healing the inserted implants in the three treatment groups are exposed via a crestal incision Mucosa and periosteum are elevated and the cover screw is removed The implant stability quotient is measured for all inserted implants The implant is rinsed with saline and a prefabricated healing abutment is placed The implants are manually tested for mobility and osseointegration by percussion Mucosa is adapted and sutured with Vicryl 4-0 The prosthetic restoration will be initiated three weeks after the healing abutment has been placed
Prosthetic restoration will include an individualized abutment and a fixed restoration performed by experienced prosthodontists with extensive clinical experience with implant-based prosthetics
Patients will be scheduled for a postoperative clinical examination at baseline and one year after loading The following parameters will be recorded at each visit 1 Plaque and gingival index probing pocket depth and probing attachment level 2 Oral health related quality of life - OHIP-14 and 3 Patient satisfaction VAS
Radiographical evaluation will include seven sets of periapical radiographs and CBCT obtained preoperatively immediately postoperatively after abutment connection at baseline and one year after loading To provide blinding of the radiographical evaluation the CBCT-scans are coded Volumetrical changes of the grafts are estimated by point counting and the method described originally by Cavalieri To obtain an equivalent starting point for the systematic uniform random sampling of the CBCT-scans images involving the maxillary sinus all images from the neighboring teeth to the implant bed are selected The first CBCT images after the distal surface of the anterior neighboring tooth is sampled randomly using a random number table for each maxillary sinus Every second CBCT image is selected to ensure an equal mutual distance between the selected 5-10 images The original outline of the maxillary sinus before implant installation is recorded and superimposed on the corresponding images A point grid test system is superimposed at random on all images allowing 100-200 points to hit the graft of each maxillary sinus The numbers of intersections over the graft are counted on each selected image Cavalieri volume estimation principle is used to estimate the total volume of the graft
V t x ap x ΣP
Where V is volume t is the distance between the sampled images ap is the area associated with each test point corrected for magnification and ΣP is the total number of points hitting the graft
Peri-implant marginal bone changes are evaluated by linear measurements on digital periapical radiographs and will be done on radiographs obtained at implant placement baseline and one year after loading The distance from the implant-abutment connection to the marginal bone level will be measured mesially and distally parallel with the long-axis of the implant
Data management and analysis including calculation of descriptive statistics are done using STATA A power calculation are based on differences in marginal bone level changes preformed in a previous study involving replacement of a single tooth with 2 different protocols of implant treatment The calculation is based on the observed changes in marginal bone level from insertion of the implant to abutment connection a change of 065 mm and a standard deviation of 065 17 patients in each group reaches a power of 97 at the 5-level With 15 to cover drop-outs each treatment group should include 20 patients The statistical evaluation is performed by analysis of variance Scheffes multiple comparison test is used post hoc to determine the relative effect of the various graft types Level of significance is 005
Symbios xenograft is a new porcine bone mineral characterized as an anorganic bone matrix with an interconnecting macro- and microscopic pore structure that supports formation and in-growth of new bone Porcine xenograft have previously been used for various augmentation procedures disclosing new bone formation Studies comparing autogenous bone graft with porcine bone alone or a mixture of autogenous bone and porcine bone have demonstrated high implant survival and new bone
Synthetic biomaterials including calcium phosphate calcium sulphate polymers and bioactive glass represent a large group of inorganic diverse biomaterials with variating structures chemical composition and physical properties Symbios biphasic biomaterials is a resorbable inorganic bone forming material derived from red algae consisting of 20 hydroxylapatite and 80 β-tricalciumphosphate Studies assessing MSFA with β-tricalciumphosphate have demonstrated that it is a safe grafting material with osteoconductive properties Histologic and radiographic examinations indicate that β-tricalciumphosphate is slowly resorbed and replaced with bone MSFA with β-tricalciumphosphate alone or in combination with autogenous bone or other bone substitutes have demonstrated high implant survival and new bone
The study purpose is to increase our knowledge about MSFA with autogenous bone alone or in combination with Symbios biphasic biomaterials or Symbios xenograft granules and to simplified the procedure Evaluation will include survival of suprastructures and implants peri-implant marginal bone level volumetrical stability of the graft and complications after an observation period of one year Furthermore oral health related quality of life using OHIP-14 self-administrated and patient satisfaction using visual analogue scales VAS will be evaluated
The objective is to test the H0 hypothesis of no differences in 1 Survival of suprastructures and implants 2 Volumetrical stability of the graft 3Peri-implant marginal bone level 4 Implantat stability quotient 5 Patient-reported outcome measures and 6 Biologic and technical complications
Materials and methods Study population 60 consecutively healthy patients with a missing posterior maxillary tooth will be included and randomly allocated to 1 MSFA with autogenous bone graft alone control group 2 mixture of 50 autogenous bone graft and 50 Symbios biphasic biomaterial test group I and 3 mixture of 50 autogenous bone and 50 Symbios xenograft test group II The study will be conducted at the Departments of Oral and Maxillofacial Surgery Aalborg University Hospital Denmark and Oral and Maxillofacial Surgery and Oral Medicine Malmö University Malmö Sweden
Patients will be included to the study by using a Facebook posting through the Universitys Facebook page the local dental association website or patients that are referred to the Departments for treatment of one or more missing teeth in the posterior maxilla All patients will be offered participation in the study if they meet the inclusion criteria Prior to patients first visit they will receive a notice informing about their rights and informed consent form will be signed
Inclusion criteria involves 1 20 years 2 Missing one or more posterior maxillary teeth 3 Residual bone height of the maxillary alveolar process between 3 to 7 mm 4 Width of the alveolar process 65 mm and 5 Mandibular occluding teeth Exclusion criteria involves 1 Contraindications to implant therapy 2 Full mouth plaque score 25 3 Progressive marginal periodontitis 4 Acute infection in the area intended for implant placement 5Parafunction bruxism or clenching 6 Psychiatric problems or unrealistic expectations 7 Heavy tobacco use define as 10 cigarettes per day and 8Pregnancy
The study is approved by the local ethical Committee on Health Research and the Danish Data Protection Agency and The Ethical Review Board in Lund Sweden and will be performed according to the Declaration of Helsinki on clinical research All patients will be given verbal and written information about the study at a clinical visit prior to surgery Written informed consent is mandatory for inclusion in the study and will be obtained by the investigators
The initial examination of the patient will include 1 Clinical examination and screening of the parodontal health 2 Radiographical examination of the residual alveolar bone height based on CBCT and Orthopantomography and 3 Patient will fill out the OHIP-14 questionnaire
The surgical procedure will be performed in local anesthesia Implant installation and fabrication of the subsequently prosthetic solution will be performed according to manufacturers recommendations The maxillary sinus wall is exposed by an intraoral marginal incision from tuber maxillae to the first premolar with a vertical releasing incision A 1 x 1 cm window to the maxillary sinus is created with metal and diamond burrs maintaining an intact Schneiderian membrane The Schneiderian membrane is elevated from the sinus floor as well as the lateral sinus wall and displaced dorsocranially with blunt dissector An implant bed is successively prepared on the top of the alveolar crest following manufactorys recommendations at 1500 rpm A straight implant ASTRA TECH Implant System EV 36 42 or 48 13 mm is inserted with a cover screw The implant stability quotient is measured for all inserted implants A sealed randomization envelope is opened in order to allocate the patient to 1 MSFA with particulated autogenous bone graft alone control group 2 a mixture of 50 particulated autogenous bone graft and 50 Symbios biphasic bone graft material 10 mm to 20 mm test group I 3 a mixture of 50 particulated autogenous bone graft and 50 Symbios xenograft granules 10 mm to 20 mm test group II The autogenous bone graft is harvested with a curved SafeScraper from the zygomatic buttress area Specially prepared stainless steel cups 05 cm3 and 1 cm3 are used to estimate 1 cm3 of graft material for each inserted implant The graft material will be soaked in autogenous blood from the surgical site until use The sinus around the implant is packed with 1 cm3 graft material The created window to the maxillary sinus is covered by a Symbios Collagen Membrane 15 x 20 mm Periosteum and mucosa are sutured with Vicryl 4-0 Minor perforations of sinus membrane will be covered with a Symbios Collagen Membrane If the sinus membrane is largely perforated the procedure will be cancelled and the patient will be withdrawn from the study No provisional restoration is inserted during the healing period After six months of healing the inserted implants in the three treatment groups are exposed via a crestal incision Mucosa and periosteum are elevated and the cover screw is removed The implant stability quotient is measured for all inserted implants The implant is rinsed with saline and a prefabricated healing abutment is placed The implants are manually tested for mobility and osseointegration by percussion Mucosa is adapted and sutured with Vicryl 4-0 The prosthetic restoration will be initiated three weeks after the healing abutment has been placed
Prosthetic restoration will include an individualized abutment and a fixed restoration performed by experienced prosthodontists with extensive clinical experience with implant-based prosthetics
Patients will be scheduled for a postoperative clinical examination at baseline and one year after loading The following parameters will be recorded at each visit 1 Plaque and gingival index probing pocket depth and probing attachment level 2 Oral health related quality of life - OHIP-14 and 3 Patient satisfaction VAS
Radiographical evaluation will include seven sets of periapical radiographs and CBCT obtained preoperatively immediately postoperatively after abutment connection at baseline and one year after loading To provide blinding of the radiographical evaluation the CBCT-scans are coded Volumetrical changes of the grafts are estimated by point counting and the method described originally by Cavalieri To obtain an equivalent starting point for the systematic uniform random sampling of the CBCT-scans images involving the maxillary sinus all images from the neighboring teeth to the implant bed are selected The first CBCT images after the distal surface of the anterior neighboring tooth is sampled randomly using a random number table for each maxillary sinus Every second CBCT image is selected to ensure an equal mutual distance between the selected 5-10 images The original outline of the maxillary sinus before implant installation is recorded and superimposed on the corresponding images A point grid test system is superimposed at random on all images allowing 100-200 points to hit the graft of each maxillary sinus The numbers of intersections over the graft are counted on each selected image Cavalieri volume estimation principle is used to estimate the total volume of the graft
V t x ap x ΣP
Where V is volume t is the distance between the sampled images ap is the area associated with each test point corrected for magnification and ΣP is the total number of points hitting the graft
Peri-implant marginal bone changes are evaluated by linear measurements on digital periapical radiographs and will be done on radiographs obtained at implant placement baseline and one year after loading The distance from the implant-abutment connection to the marginal bone level will be measured mesially and distally parallel with the long-axis of the implant
Data management and analysis including calculation of descriptive statistics are done using STATA A power calculation are based on differences in marginal bone level changes preformed in a previous study involving replacement of a single tooth with 2 different protocols of implant treatment The calculation is based on the observed changes in marginal bone level from insertion of the implant to abutment connection a change of 065 mm and a standard deviation of 065 17 patients in each group reaches a power of 97 at the 5-level With 15 to cover drop-outs each treatment group should include 20 patients The statistical evaluation is performed by analysis of variance Scheffes multiple comparison test is used post hoc to determine the relative effect of the various graft types Level of significance is 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None