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

Primary Purpose

Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Implant placement
immediate loading
conventional loading
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw focused on measuring Dentistry, Mandibular Atrophy, Mandibular Overdenture

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional loading

Immediate Loading

Arm Description

Loading of 4 interforaminal implants three months after surgery.

Loading of 4 interforaminal implants immediately after surgery.

Outcomes

Primary Outcome Measures

Change of Implant stability
Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration
Change of Implant stability
Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
February 28, 2020
Sponsor
Medical University of Graz
Collaborators
Neoss Ltd., Harrogate, UK
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1. Study Identification

Unique Protocol Identification Number
NCT04292132
Brief Title
Two Interforaminal Implants in an Immediate or Delayed Loading Protocol for the Elderly
Official Title
Prospektive Langzeitstudie Zur Implantatprothetischen Versorgung
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2012 (Actual)
Primary Completion Date
September 28, 2015 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Neoss Ltd., Harrogate, UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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®.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw
Keywords
Dentistry, Mandibular Atrophy, Mandibular Overdenture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional loading
Arm Type
Active Comparator
Arm Description
Loading of 4 interforaminal implants three months after surgery.
Arm Title
Immediate Loading
Arm Type
Experimental
Arm Description
Loading of 4 interforaminal implants immediately after surgery.
Intervention Type
Procedure
Intervention Name(s)
Implant placement
Intervention Description
interforaminal placement of 2 implants
Intervention Type
Procedure
Intervention Name(s)
immediate loading
Intervention Description
immediate loading with a locator retained mandibular overdenture
Intervention Type
Procedure
Intervention Name(s)
conventional loading
Intervention Description
conventional loading with a locator retained mandibular overdenture 3 months postoperatively
Primary Outcome Measure Information:
Title
Change of Implant stability
Description
Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration
Time Frame
0,3,6,12,24,36 months
Title
Change of Implant stability
Description
Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration
Time Frame
0,3,6,12,24,36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan Acham, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8051
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

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

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