Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292132
Other study ID # MUGraz Neoss1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2, 2012
Est. completion date December 30, 2018

Study information

Verified date February 2020
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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®.


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:

1. Intraoperative torque measurement in Ncm

2. Radiological measurement of periimplant bone height using orthopantomogram

3. 4-point measurement of peri-implant probing depth using WHO periodontal probe. The measurement is mesial, distal, buccal and lingual of the implant.

4. Measurement of bleeding on probing (parameters of peri-implant inflammation) using the WHO periodontal probe.

5. 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date December 30, 2018
Est. primary completion date September 28, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Implant placement
interforaminal placement of 2 implants
immediate loading
immediate loading with a locator retained mandibular overdenture
conventional loading
conventional loading with a locator retained mandibular overdenture 3 months postoperatively

Locations

Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (2)

Lead Sponsor Collaborator
Medical University of Graz Neoss Ltd., Harrogate, UK

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Implant stability Evaluation of Implant stability with Resonance frequency analysis (Ostell®) indicating quality of osseointegration 0,3,6,12,24,36 months
Primary Change of Implant stability Evaluation of implant stability with electromechanical tapping (Periotest®) indicating quality of osseointegration 0,3,6,12,24,36 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05082038 - Mandibular Full-arch Rehabilitation With Internal Hexagonal and Conical Connection Implants N/A
Completed NCT01411683 - Mandibular Overdentures Retained by Conventional or Mini Implants N/A
Completed NCT05924451 - Study of Hard and Soft Tissue Behavior Around Abutments on Implants. N/A
Completed NCT04851002 - Effects of Different Centrifuged Platelet Concentrates on Bone Remodelling Around Dental Implants N/A
Completed NCT01230320 - Simplified vs. Conventional Methods for Complete Denture Fabrication N/A
Active, not recruiting NCT05062863 - An Observational Clinical Study of the T3 Dental Implant System
Active, not recruiting NCT04354688 - T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD N/A
Not yet recruiting NCT06152432 - Maxillary Implant Overdentures Retained by Bars or Locator N/A
Completed NCT06209814 - Evaluation of Open-face Maxillary Complete Denture for Patients With Prominent Premaxilla N/A
Recruiting NCT04662333 - Adjunctive Benefit of Xenograft Plus a Membrane During Sinus Crestal Approach N/A
Active, not recruiting NCT04237545 - A Clinical Study of the T3 Short Dental Implant System N/A
Active, not recruiting NCT04236336 - A Clinical Study of the TSV Dental Implant System
Not yet recruiting NCT03674554 - Prosthetic Complications of Screw Retained Restoration N/A
Not yet recruiting NCT06155630 - 3D Printing for the Fabrication of Mandibular Implant Overdentures N/A
Recruiting NCT04429373 - Effect of Platelet-rich Plasm (PRF) on Two-implant Mandibular Overdenture: a Split Mouth N/A
Completed NCT06146153 - Intra Oral Scanning of Edentulous Arches
Completed NCT05777980 - Effect of Prosthetic Rehabilitation on Nutritional Status of Geriatric Patients
Completed NCT03992300 - Comparison of Full-arch Implant-supported Frameworks From an Intraoral Scanning or From a Conventional Impression N/A
Completed NCT03538184 - Molecular Content of Peri-implant Sulcus During Wound Healing and Osseointegration Following Drilling and Piezosurgery N/A
Not yet recruiting NCT06393582 - Accuracy Evaluation of Implant Impressions: A Prospective Study N/A