Clinical trial NCT02123420: Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Official title: Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Missing Teeth
Keywords: Platform Switching vs Regular Platform
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 18
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* need for single bilateral fixed implant-supported prosthesis in molar area
* stable interocclusal contacts
* ≥18 years of age
* provided written informed consent
* residual bone height ≥10 mm
* residual bone thickness ≥6 mm with at least 5 mm of keratinised gingiva crestally

Exclusion Criteria:

* general contraindications to implant surgery
* lack of occluding dentition in the area intended for immediate loading
* periodontitis
* bruxism
* immunosuppression
* previous history of irradiation of the head and neck area
* uncontrolled diabetes
* heavy smoker (\>10 cigarettes/day)
* poor oral hygiene
* current or past treatment with bisphosphonates
* substance abuse
* psychiatric disorder
* inability to complete follow-up ≥1 year
* lactation
* implant insertion torque less than 35 Ncm

Primary outcomes:
measure: Implant Survival
timeFrame: Up to 12 months
Secondary outcomes:
measure: Change in marginal bone levels
timeFrame: Baseline, 12 months
Other outcomes:
measure: Change in peri-implant mucosal response parameters.
timeFrame: Baseline, 12 months
Locations:
Study officials:
References: