NCT04292132

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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2015

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

June 26, 2019

Last Update Submit

February 28, 2020

Conditions

Edentulous Jaw

Keywords

DentistryMandibular AtrophyMandibular Overdenture

Outcome Measures

Primary Outcomes (2)

  • Change of Implant stability

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

    0,3,6,12,24,36 months

  • Change of Implant stability

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

    0,3,6,12,24,36 months

Study Arms (2)

Conventional loading

ACTIVE COMPARATOR

Loading of 4 interforaminal implants three months after surgery.

Procedure: Implant placementProcedure: conventional loading

Immediate Loading

EXPERIMENTAL

Loading of 4 interforaminal implants immediately after surgery.

Procedure: Implant placementProcedure: immediate loading

Interventions

Implant placementPROCEDURE

interforaminal placement of 2 implants

Conventional loadingImmediate Loading
immediate loadingPROCEDURE

immediate loading with a locator retained mandibular overdenture

Immediate Loading
conventional loadingPROCEDURE

conventional loading with a locator retained mandibular overdenture 3 months postoperatively

Conventional loading

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, Styria, 8051, Austria

Location

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Stephan Acham, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

March 2, 2020

Study Start

July 2, 2012

Primary Completion

September 28, 2015

Study Completion

December 30, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)