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Completed

NCT Number: NCT04292132

Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly

The study population comprises 20 completely edentulous patients aged 60 years and older with severe mandible resorption. Each patient receives two inter-foraminal implants (Neoss Ltd., Harrogate, UK). Following randomization, implants are loaded either immediately after dental implant surgery or three months after implant placement with the Locator®-abutment system. At follow-up visits 3, 6 12, 24 and 36 months after loading, implant stability is evaluated with Periotest® and Ostell®.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Graz

Graz, Styria, 8051, Austria

About this study

Hypothesis:

Especially for gerontoprosthetics, the Locator® abutment system offers the possibility of a minimally invasive retention of prosthetic total restorations of edentulous mandibles. The reduced number of 2 interforaminal implants is intended to ensure implantological anchoring with minimal surgical, technical, financial and time expenditure.

Research Question:

How safe is this minimally invasive and cost-effective implant and anchoring system in terms of long-term outcome? Are the two implant-prosthetic procedures (immediate versus late restoration) different in terms of implant survival time?

Materials and methods

Enrollment:

  • 20 patients without relevant pre-existing conditions, from the age of 60 years
  • edentulous mandible, alveolar ridge atrophy

Statistical Analysis:

When planning the study, it is estimated that bone resorption in the peri-implant area of the immediate-care implants is greater than in the late-treated implants. 10 patients per group are required with a t-test (α = 0.05) and a power of 80% if the null hypothesis is formulated as follows: -difference of means is 0 and the alternative - expected difference of means is 1mm, common standard deviation is 0.75.

Collective A (open healing - immediate loading): Insertion of a new, prefabricated total mandibular prosthesis on the day of the operation immediately postoperatively after screwing in the Locator® abutments.

Polymerization of the corresponding Locator® matrices in the newly incorporated lower jaw denture in the patient's mouth.

Collective B (closed implant healing - conventional loading): 3 months after implantation Exposure of the primary closed implants. Immediately following insertion of the prefabricated full-thickness UK prosthesis and retention by the implants using Locator® abutments.

Test parameters:

  • Intraoperative torque measurement in Ncm
  • Radiological measurement of periimplant bone height using orthopantomogram
  • 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant.
  • Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe.
  • Analysis of implant stability using the Periotest® and Osstell® measuring instruments according to a standardized scheme: The strength values are performed in a measuring range consisting of a straight line through the center of the implant and the resulting 180 ° circle sector anterior to this line results. After multiple measurements (5-fold) the lowest numerical value for the Periotest® and for the RFA (Osstell®) the lowest value documented.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 60 or older
  • edentulous lower jaw with advanced atrophy
  • poor fit and retention even with a new prosthesis

Exclusion criteria

  • poor general condition (ASA classification grade IV or more), or
  • high risk situations for implant therapy (e.g. disorders of bone metabolism due to antiresorptive therapy)

Treatment and study plan

implant placement

Procedure

interforaminal placement of 2 implants

Immediate loading

Procedure

immediate loading with a locator retained mandibular overdenture

Conventional Loading

Procedure

conventional loading with a locator retained mandibular overdenture 3 months postoperatively

Primary outcomes

  1. Change of Implant stability

    Time frame: 0,3,6,12,24,36 months

    Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration

  2. Change of Implant stability

    Time frame: 0,3,6,12,24,36 months

    Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Neoss Ltd., Harrogate, UK

Registry information

Official study title

Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung

Important dates

Study start
2012
Primary completion
2015
Study completion
2018
First posted
Mar 2, 2020
Registry last updated
Mar 2, 2020

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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