Clinical Trial: Platform Switching vs Regular Platform Implants. One Year Results From a RCT

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Platform Switching vs Regular Platform Implants. One Year Results From a RCT

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 Summary: 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.
Sponsor: Università degli Studi di Sassari

Current Primary Outcome: Implant Survival [ Time Frame: Up to 12 months ]

implant survival: The removal of implants was dictated by instability, progressive marginal bone loss, infection or implant fracture.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in marginal bone levels [ Time Frame: Baseline, 12 months ]

Marginal bone levels: Peri-implant marginal bone levels were evaluated on intraoral digital radiographs taken with the parallel technique at the time of implant placement, at 6 months and 12 months.

If radiographs were inconclusive, they were repeated. A blinded radiologist (F.G.), unaffiliated with the study centre, interpreted all radiographs. The distances from the mesial and distal interproximal bone to the reference point (the horizontal interface between the implant and abutment) were measured with a software measurement tool (NIH Scion Image programme version 4.0.2, Frederick, MD, USA) calibrated against the space between two threads to the nearest 0.1 mm, and the mean of these two measurements was calculated for each implant. The measurements were recorded with reference to the implant axis.



Original Secondary Outcome: Same as current

Information By: Università degli Studi di Sassari

Dates:
Date Received: April 16, 2014
Date Started: November 2011
Date Completion:
Last Updated: April 23, 2014
Last Verified: April 2014