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

Primary Purpose

Missing Teeth

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)
Sponsored by
Università degli Studi di Sassari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missing Teeth focused on measuring Platform Switching vs Regular Platform

Eligibility Criteria

24 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    Implant outcome

    Implant outome

    Arm Description

    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)

    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)

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Change in marginal bone levels
    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.

    Full Information

    First Posted
    April 16, 2014
    Last Updated
    April 23, 2014
    Sponsor
    Università degli Studi di Sassari
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02123420
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    February 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Sassari

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missing Teeth
    Keywords
    Platform Switching vs Regular Platform

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Implant outcome
    Arm Type
    Other
    Arm Description
    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)
    Arm Title
    Implant outome
    Arm Type
    Other
    Arm Description
    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)
    Intervention Type
    Device
    Intervention Name(s)
    Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)
    Other Intervention Name(s)
    Nobel Replace Tapered Groovy PS implant; (Nobel Biocare®, Sweden), Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Implant Survival
    Description
    implant survival: The removal of implants was dictated by instability, progressive marginal bone loss, infection or implant fracture.
    Time Frame
    Up to 12 months
    Secondary Outcome Measure Information:
    Title
    Change in marginal bone levels
    Description
    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.
    Time Frame
    Baseline, 12 months
    Other Pre-specified Outcome Measures:
    Title
    Change in peri-implant mucosal response parameters.
    Description
    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.
    Time Frame
    Baseline, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    24 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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