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Randomized Study For Minimally Invasive Splinted Implants

U

University of Concepcion, Chile

Status

Completed

Conditions

Jaw, Edentulous

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02107612
FONDEF V09E0007

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

45 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

43 participants in 2 patient groups

Integrated system to insert two splinted (bar) miniimplants
Experimental group
Description:
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.
Treatment:
Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture
Denture
Active Comparator group
Description:
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.
Treatment:
Other: Denture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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