Randomized Study For Minimally Invasive Splinted Implants

Sponsor

University of Concepcion, Chile (Other)

Overall Status

Completed

CT.gov ID

NCT02107612

Collaborator

Public Health Service of Chile (Other)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2004

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

Change in Quality of Life [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

Incidence of complications [Two years]
Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.

Other Outcome Measures

Average marginal bone loss in the peri-implant zone [Two years]
Average of maximal bite force [Fifteen months]
Mini-implant survival rate [Two years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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