Randomized Study For Minimally Invasive Splinted Implants

April 8, 2014 updated by: Jorge Jofre, University of Concepcion, Chile

Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial

The purpose of this study was to evaluate the effect of a integrated system for inserting two splinted minimally-invasive implants, to retain mandibular over dentures, on the quality of life of edentulous patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Región del Bio Bio
      • Concepción, Región del Bio Bio, Chile, 4070420
        • University of Concepción

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Edentulous
  • Men and women
  • Between 45 and 90 years of age
  • Who had a persistent loss of stability and retention of their conventional mandibular dentures
  • Without temporomandibular disorders

Exclusion Criteria:

  • Uncontrolled systemic disease (eg, hypertension, diabetes)
  • Severe osteoporosis (bone mineral density > 2.5 SD below the young adult reference mean, plus 1 or more fragility fractures) and/or taking bisphosphonates
  • Mental disorders
  • Who had received radiotherapy in the 18 months prior to the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrated system to insert two splinted (bar) miniimplants
Participants were randomly assigned to experimental group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator.
Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture
Other Names:
  • Easy2Fix
Active Comparator: Denture
Participants were randomly assigned to comparator group following a simple randomization procedure (computer-generated list of random numbers). Allocation by telephone was carried out with an independent collaborator.
Other: Denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: One year
Quality of life was assessed using the Oral Health Impact Profile (OHIP) for assessing health-related quality of life in edentulous adults (EDENT) scale with 19 items.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: Two years
Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.
Two years

Other Outcome Measures

Outcome Measure
Time Frame
Average marginal bone loss in the peri-implant zone
Time Frame: Two years
Two years
Average of maximal bite force
Time Frame: Fifteen months
Fifteen months
Mini-implant survival rate
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Concepcion, Chile

Collaborators

Public Health Service of Chile

Investigators

  • Principal Investigator: Jorge Jofre, DDS, PhD, University of Concepción

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

April 9, 2014

Last Update Submitted That Met QC Criteria

April 8, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FONDEF V09E0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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