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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
Sponsor:
Collaborator:
Public Health Service of Chile
Information provided by (Responsible Party):
Jorge Jofre, University of Concepcion, Chile

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

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 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.
Other: Denture



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of complications [ Time Frame: Two years ]
    Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.


Other Outcome Measures:
  1. Average marginal bone loss in the peri-implant zone [ Time Frame: Two years ]
  2. Average of maximal bite force [ Time Frame: Fifteen months ]
  3. Mini-implant survival rate [ Time Frame: Two years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Chile
University of Concepción
Concepción, Región del Bio Bio, Chile, 4070420
Sponsors and Collaborators
University of Concepcion, Chile
Public Health Service of Chile
Investigators
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Principal Investigator: Jorge Jofre, DDS, PhD University of Concepcion

Publications of Results:
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Responsible Party: Jorge Jofre, Jorge Jofre DDs, PhD, University of Concepcion, Chile
ClinicalTrials.gov Identifier: NCT02107612     History of Changes
Other Study ID Numbers: FONDEF V09E0007
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014
Keywords provided by Jorge Jofre, University of Concepcion, Chile:
Mini-Dental Implant
Implant-Supported Dental Prosthesis
Minimally Invasive Surgical procedures
Overdentures
Aged
Additional relevant MeSH terms:
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Jaw, Edentulous
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases