Randomized Study For Minimally Invasive Splinted Implants

Not Applicable

Completed

• Conditions: Jaw, Edentulous
• Interventions: Device: Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture; Other: Denture

• Registration Number: NCT02107612
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2006-04
• Study Completion: 2007-07
• Status Verified: 2014-04
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-08
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated system to insert two splinted (bar) miniimplants	Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture	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.
Denture	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of complications	Two years	Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis.

Trial Locations

Locations (1)

University of Concepción; 🇨🇱 Concepción, Región del Bio Bio, Chile