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Completed

NCT Number: NCT02123420

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

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.

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Key information

Conditions

Missing Teeth Anodontia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

24 year–72 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)

Device

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: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare®, Sweden), Nobel Replace Tapered Groovy implant with Replace Select connection (Nobel Biocare®, Sweden)

Primary outcomes

  1. 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

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2014
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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