Randomized Study For Minimally Invasive Splinted Implants

Study Overview
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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.

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

Conditions
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Jaw, Edentulous

Intervention / Treatment
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* Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture
* Other: Denture


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated system to insert two splinted (bar) miniimplants<br>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<br> <br> * Other names: Easy2Fix;|
| Active Comparator: Denture<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life | 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 | Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis. | Two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini-Dental Implant, Implant-Supported Dental Prosthesis, Minimally Invasive Surgical procedures, Overdentures, Aged