Randomized Study For Minimally Invasive Splinted Implants

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

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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