Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Missing Teeth
- Sponsor
- Università degli Studi di Sassari
- Enrollment
- 18
- Primary Endpoint
- Implant Survival
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Silvio Mario Meloni
DDS, Phd, MS
Università degli Studi di Sassari
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
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in marginal bone levels(Baseline, 12 months)