Randomized Study For Minimally Invasive Splinted Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Jaw, Edentulous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Denture

Intervention Type OTHER

Interventions

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Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture

Intervention Type DEVICE

Denture

Intervention Type OTHER

Other Intervention Names

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Easy2Fix

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No