Randomized Study For Minimally Invasive Splinted Implants
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|ClinicalTrials.gov Identifier: NCT02107612|
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : April 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous||Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture Other: Denture||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Development of Minimally Invasive Splinted Dental Implants to Stabilize Mandibular Overdentures, a Randomized Clinical Trial|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||April 2006|
|Actual Study Completion Date :||July 2007|
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 Name: 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.
- 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.
- Incidence of complications [ Time Frame: Two years ]Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.
- Average marginal bone loss in the peri-implant zone [ Time Frame: Two years ]
- Average of maximal bite force [ Time Frame: Fifteen months ]
- Mini-implant survival rate [ Time Frame: Two years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107612
|University of Concepción|
|Concepción, Región del Bio Bio, Chile, 4070420|
|Principal Investigator:||Jorge Jofre, DDS, PhD||University of Concepcion|