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Completed

NCT Number: NCT02107612

Randomized Study For Minimally Invasive Splinted Implants

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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Key information

Conditions

Jaw, Edentulous Jaw Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Concepción

Concepción, Región Del Bio Bio, 4070420, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Other names: Easy2Fix

Denture

Other

Primary outcomes

  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 outcomes

  1. Incidence of complications

    Time frame: Two years

    Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Concepcion, Chile

Other

Collaborators

  • Public Health Service of Chile

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2007
First posted
Apr 8, 2014
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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