- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02123420
Platform Switching vs Regular Platform Implants. One Year Results From a RCT
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Implant outcome
This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area. A total of 18 consecutive patients were enrolled. In each eligible patient, the right molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP) |
Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group). Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).
Other Names:
|
Other: Implant outome
This study was designed as a randomised, controlled, split-mouth trial. all enrolled patients needed single bilateral fixed implant-supported prosthesis in molar area. A total of 18 consecutive patients were enrolled. In each eligible patient, the left molar was randomly selected to receive either Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Goteborg, Sweden) with Platform Switching (PS) or Regular Platform (RP) |
Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group). Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline, 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in peri-implant mucosal response parameters.
Time Frame: Baseline, 12 months
|
Peri-implant mucosal response: Probing pocket depth (PPD) and bleeding on probing (BOP) were measured by a blinded operator (A.D.) with a periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Chicago, IL, USA) at 6 and 12 months.
Three vestibular and 3 lingual values were collected for every implant by the same dentist.
|
Baseline, 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS vs RP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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