Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02405169
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2015-03-16
Brief Title:
4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti Cad-cam Framework
Sponsor:
Institute Franci
Organization:
Institute Franci
Study Overview
Official Title:
Four Versus Six Endosseous Implants to be Used in the Rehabilitation of Totally Edentulous Patient in the Maxilla With Titanium Milled Framework
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The primary objective of the present study is to evaluate the marginal bone level changes occurring in total edentulous patients treated with six or four implants
Secondary objective
overall survival rate
soft tissue status by assessment of bleeding on probing BoP and probing pocket depth PPD at baseline and after 135 years
prosthetic survival rates including screw or abutment loosening framework or veneer fractures
Secondary objective
overall survival rate
soft tissue status by assessment of bleeding on probing BoP and probing pocket depth PPD at baseline and after 135 years
prosthetic survival rates including screw or abutment loosening framework or veneer fractures
Detailed Description:
METHODSPROCEDURES A randomized controlled multi-center clinical study is designed to determine whether a difference exists between the outcome of treatment when Astra tech implants are placed according to a six or a four implants protocol The investigation will be performed in four centers three in Italy affiliated to Institute Franci and one affiliated to the Department of Prosthodontics Faculty of Odontology Malmö University In each center the clinician and the examiner will be the same person The study protocol will be approved by the Regional Human Review Board of Padova General Hospital
An investigators meeting will be arranged prior to the starting with the patients recruitment Following a screening examination subjects who will meet the inclusion criteria will sign the Informed Consent and will be enrolled in the study The period of patient enrollment will begin on January 1 2013 and ends December 31 2013
The patients will be randomized with a method based on the use of sealed opaque envelopes The cases will be assigned to two different treatment groups
Group A- four implants Test Group B- six implants Control
Pre-treatment Patient data medical history clinical and radiographic examination will be recorded for each patient Clinical photographs will be taken in frontal occlusal and lateral projections
Periodontal endodontic and open caries lesions will be treated prior to implant installation All patients will receive careful oral hygiene instructions and training in self-performed
plaque control measure CT scan computed exams will be carried out Plaster models and diagnostic wax-up will be carried out
First Surgical Phase Implant Installation The patient will receive antibiotic prophylaxis Amoxicillin 1gr one hour prior to surgery and after the completion of implant installation until suture removal with 1gr three times a day If the patient is allergic to amoxicillin the examiner prescribes antibiotics at his own discretion at the same posology
The surgical treatment will be performed under local anesthesia In case of remaining teeth they will be extracted with conventional technique before implants placement 13-14 Implants will be placed according to the guidelines described in the Astra Tech manual Surgical procedures using a two-stage protocol
Implant spinning during the positioning of the cover screw will be registered as positive if present or negative
The operation will be finalized by a careful adaption of the flaps by means of an accurate suture in order to obtain a full periosteal coverage
Intraoral clinical photographs before during and after surgery will be taken
Post-operative care The patients will be instructed to rinse with chlorhexidine 012 mouthrinse and will be told to rinse with the antiseptic solution three times a day for 2 weeks The patients will be advised to take NSAIDs for pain relief at their own discretion
Liquid and semisolid food will be prescribed for the first post-operative week after which the sutures will be removed
Two weeks after the operation the denture will be properly relined until the second stage surgery
Patients will be controlled at third and sixth weeks
Second surgical phase and Prosthetic procedures After eight weeks 2 of healing in both groups A and B Uni Abutment 45 connection procedure will be performed Impression with a customized spoon and Impregum material will be taken and the prosthetic procedure will be performed according to the Atlantis-Isus recommendations
After 6 weeks 2 from Uni Abutment connection the definitive full-arch fixed dental prostheses screw retained will be applied The prosthesis will be made to accomplish the normal hygienic procedures All prosthetic procedures will be made in accordance to the Astra Tech procedures products manuals
The length of bridge cantilevers will be duly calculated to minimize implant overloading according to the Atlantis-Isus recommendations 15
Post-prosthetic measurements Clinical measurements Clinical examinations will be performed immediately following the installation of the definitive prosthesis Baseline-Loading and after 1 3 and 5 years In particular plaque and soft-tissue inflammation will be registered Clinical photographs will be taken at each interval point
Plaque the presence of plaque will be scored at each implant site as well as at level of the remaining teeth on four surfaces buccal lingualpalatal mesial distal The mean percentage of plaque harboring surfaces will be calculated using the case as the unit
Soft-tissue inflammation the presence of soft-tissue inflammation bleeding on probing will be assessed on buccal lingualpalatal mesial distal aspects of each implant The mean percentage of inflamed sites will be calculated using the case as the unit
Radiographic measurements Peri-apical radiographs will be taken at prosthesis insertion Baseline and after 1 3 and 5 years
The radiographs will be taken with an X-ray apparatus supplied with a long cone by the examiner each visiting time Rinn centrators will be used to ensure reproducibility in the measurement of marginal bone level change
The radiographic images will be analysed at the Department of Radiology of Sahlgrenska Academy Gothenburg University by experienced radiologists who will be otherwise not involved in the study
An investigators meeting will be arranged prior to the starting with the patients recruitment Following a screening examination subjects who will meet the inclusion criteria will sign the Informed Consent and will be enrolled in the study The period of patient enrollment will begin on January 1 2013 and ends December 31 2013
The patients will be randomized with a method based on the use of sealed opaque envelopes The cases will be assigned to two different treatment groups
Group A- four implants Test Group B- six implants Control
Pre-treatment Patient data medical history clinical and radiographic examination will be recorded for each patient Clinical photographs will be taken in frontal occlusal and lateral projections
Periodontal endodontic and open caries lesions will be treated prior to implant installation All patients will receive careful oral hygiene instructions and training in self-performed
plaque control measure CT scan computed exams will be carried out Plaster models and diagnostic wax-up will be carried out
First Surgical Phase Implant Installation The patient will receive antibiotic prophylaxis Amoxicillin 1gr one hour prior to surgery and after the completion of implant installation until suture removal with 1gr three times a day If the patient is allergic to amoxicillin the examiner prescribes antibiotics at his own discretion at the same posology
The surgical treatment will be performed under local anesthesia In case of remaining teeth they will be extracted with conventional technique before implants placement 13-14 Implants will be placed according to the guidelines described in the Astra Tech manual Surgical procedures using a two-stage protocol
Implant spinning during the positioning of the cover screw will be registered as positive if present or negative
The operation will be finalized by a careful adaption of the flaps by means of an accurate suture in order to obtain a full periosteal coverage
Intraoral clinical photographs before during and after surgery will be taken
Post-operative care The patients will be instructed to rinse with chlorhexidine 012 mouthrinse and will be told to rinse with the antiseptic solution three times a day for 2 weeks The patients will be advised to take NSAIDs for pain relief at their own discretion
Liquid and semisolid food will be prescribed for the first post-operative week after which the sutures will be removed
Two weeks after the operation the denture will be properly relined until the second stage surgery
Patients will be controlled at third and sixth weeks
Second surgical phase and Prosthetic procedures After eight weeks 2 of healing in both groups A and B Uni Abutment 45 connection procedure will be performed Impression with a customized spoon and Impregum material will be taken and the prosthetic procedure will be performed according to the Atlantis-Isus recommendations
After 6 weeks 2 from Uni Abutment connection the definitive full-arch fixed dental prostheses screw retained will be applied The prosthesis will be made to accomplish the normal hygienic procedures All prosthetic procedures will be made in accordance to the Astra Tech procedures products manuals
The length of bridge cantilevers will be duly calculated to minimize implant overloading according to the Atlantis-Isus recommendations 15
Post-prosthetic measurements Clinical measurements Clinical examinations will be performed immediately following the installation of the definitive prosthesis Baseline-Loading and after 1 3 and 5 years In particular plaque and soft-tissue inflammation will be registered Clinical photographs will be taken at each interval point
Plaque the presence of plaque will be scored at each implant site as well as at level of the remaining teeth on four surfaces buccal lingualpalatal mesial distal The mean percentage of plaque harboring surfaces will be calculated using the case as the unit
Soft-tissue inflammation the presence of soft-tissue inflammation bleeding on probing will be assessed on buccal lingualpalatal mesial distal aspects of each implant The mean percentage of inflamed sites will be calculated using the case as the unit
Radiographic measurements Peri-apical radiographs will be taken at prosthesis insertion Baseline and after 1 3 and 5 years
The radiographs will be taken with an X-ray apparatus supplied with a long cone by the examiner each visiting time Rinn centrators will be used to ensure reproducibility in the measurement of marginal bone level change
The radiographic images will be analysed at the Department of Radiology of Sahlgrenska Academy Gothenburg University by experienced radiologists who will be otherwise not involved in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None