Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-26 @ 12:20 AM
Study NCT ID:
NCT02123420
Status:
COMPLETED
Last Update Posted:
2014-04-25
First Post:
2014-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Sponsor:
Università degli Studi di Sassari
Organization:
Study Overview
Official Title:
Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Status:
COMPLETED
Status Verified Date:
2014-04
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 present study tested the hypothesis that Platform Switching (PS) and Regular Platform (RP) implants would have different outcomes in the bilateral single tooth replacements against the alternative hypothesis of no difference.
Detailed Description:
This study was designed as a randomised, controlled, split-mouth trial. Eighteen patients, with bilaterally missing single bicuspid or molar had one of the sites to be restored randomly assigned to be treated according to the platform-switching concept with (PS group), or with matching implant-abutment diameters, (RP group). A total of 36 implants, (18 Nobel Replace Tapered Groovy PS, 18 Nobel Replace Tapered Groovy), were bilaterally installed. All the implants were inserted with an insertion torque between 35 and 45 Ncm, in healed healthy bone and the healing abutment was connected at the same time. Both implants were delayed loaded with screw retained temporary crowns 3 months after implant insertion and with screw retained definitive crowns 2 months later. Outcome measures were implant survival, biological and prosthetic complications, radiographic marginal bone-level changes, soft tissue parameters (PPD and BOP). Clinical data were collected at baseline 6 and 12 months. Statistical analyses were conducted using computational program SAS (version 9.2), with 1-away ANOVA and F-test. Statistical significance was tested at the 0.05 probability level, and all values were presented as mean and standard deviation with 95% confidence intervals.
Study Oversight
Has Oversight DMC:
False
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?: