Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04369170
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2020-04-23
Brief Title:
Changes on the Interproximal Bone Level on Direct Prostheses or With Intermediate Abutments
Sponsor:
University of Santiago de Compostela
Organization:
University of Santiago de Compostela
Study Overview
Official Title:
Changes on the Interproximal Marginal Bone Level After CAD-CAM Designed Bridges Directly Placed on Bone-level Implants or With Intermediate Abutments A Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Study Title Changes on the Interproximal marginal bone level after CAD-CAM designed bridges directly placed on bone-level implants or with intermediate abutments A Randomized Clinical Trial
Objectives To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CADCAM designed prosthesis with an intermediate abutment 3mm long or directly placed to bonelevel implants Secondary objectives will be evaluate changes on the soft tissues and implant survival as well as patients satisfaction 3 6 and 12 months after the connection of the definitive prosthesis
Design and Outcomes Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed
Interventions and Duration Patients will be selected according to the inclusionexclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela After clinical and radiological implant planning implant surgical placement will be scheduled 2 MOZO GRAU INHEX ST implants with 375 mm or 425 mm of diameter and 8mm 10mm or 115mm length will be placed on each patient according to the bone availability After 8 weeks of submerged healing second stage surgery will be performed and definitive impression will be taken All groups patients will keep a heeling abutment until the definitive prosthesis is placed 3 weeks later test group direct to implant control group abutment 3 mm long Clinical and radiological assessment after 1 3 6 and 12 months will be performed Each participant will be on study about 15 months since the recruitment visit until the end of the study
Sample Size and Population Based on previous studies a sample size calculation determined that a group of 32 subjects considering possible dropouts will provide 80 power to detect a true radiographic difference of 080mm between groups after 12 months of observation since the definitive prosthesis connection Blanco et al 2017 Nóvoa et al 2017 A common standard deviation between groups was calculated SD0715268015 A p 005 value will be considered significant JM Domenech R Granero 2010 A balanced random permuted block will be applied to prepare the randomization tables stratifying for smoking habits yesno with a 11 ratio between test and control groups
Objectives To evaluate differences on changes on the interproximal marginal bone level 12 months after the connection of CADCAM designed prosthesis with an intermediate abutment 3mm long or directly placed to bonelevel implants Secondary objectives will be evaluate changes on the soft tissues and implant survival as well as patients satisfaction 3 6 and 12 months after the connection of the definitive prosthesis
Design and Outcomes Randomized double-blinded clinical trial with parallel design to asses the effect of CADCAM designed bridges directly placed
Interventions and Duration Patients will be selected according to the inclusionexclusion criteria among those who attend the Unit of Periodontology of the University of Santiago de Compostela After clinical and radiological implant planning implant surgical placement will be scheduled 2 MOZO GRAU INHEX ST implants with 375 mm or 425 mm of diameter and 8mm 10mm or 115mm length will be placed on each patient according to the bone availability After 8 weeks of submerged healing second stage surgery will be performed and definitive impression will be taken All groups patients will keep a heeling abutment until the definitive prosthesis is placed 3 weeks later test group direct to implant control group abutment 3 mm long Clinical and radiological assessment after 1 3 6 and 12 months will be performed Each participant will be on study about 15 months since the recruitment visit until the end of the study
Sample Size and Population Based on previous studies a sample size calculation determined that a group of 32 subjects considering possible dropouts will provide 80 power to detect a true radiographic difference of 080mm between groups after 12 months of observation since the definitive prosthesis connection Blanco et al 2017 Nóvoa et al 2017 A common standard deviation between groups was calculated SD0715268015 A p 005 value will be considered significant JM Domenech R Granero 2010 A balanced random permuted block will be applied to prepare the randomization tables stratifying for smoking habits yesno with a 11 ratio between test and control groups
Detailed Description:
Changes on the interproximal periimplant marginal bone level measured as the distance between the bone crest to the first implant to bone contact using periapical radiographs will be evaluated
Each patient will receive to implants that will be rehabilitated with an implant supported prosthesis being the test group a prosthesis connected directly to the implants while the control group will be a prosthesis connected to the implants through intermediate abutments
Each patient will receive to implants that will be rehabilitated with an implant supported prosthesis being the test group a prosthesis connected directly to the implants while the control group will be a prosthesis connected to the implants through intermediate abutments
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?:
False
Is an FDA AA801 Violation?:
None