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Randomized Study For Minimally Invasive Splinted Implants

Primary Purpose

Jaw, Edentulous

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

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

Denture

About this trial

This is an interventional treatment trial for Jaw, Edentulous focused on measuring Mini-Dental Implant, Implant-Supported Dental Prosthesis, Minimally Invasive Surgical procedures, Overdentures, Aged

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Concepción

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated system to insert two splinted (bar) miniimplants

Denture

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Quality of Life

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

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

Full Information

NCT ID

NCT02107612

First Posted

April 4, 2014

Last Updated

April 8, 2014

Sponsor

University of Concepcion, Chile

Collaborators

Public Health Service of Chile

1. Study Identification

Unique Protocol Identification Number

NCT02107612

Brief Title

Randomized Study For Minimally Invasive Splinted Implants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Concepcion, Chile

Collaborators

Public Health Service of Chile

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaw, Edentulous

Keywords

Mini-Dental Implant, Implant-Supported Dental Prosthesis, Minimally Invasive Surgical procedures, Overdentures, Aged

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Integrated system to insert two splinted (bar) miniimplants

Arm Type

Experimental

Arm Description

Arm Title

Denture

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

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

Other Intervention Name(s)

Easy2Fix

Intervention Type

Other

Intervention Name(s)

Denture

Primary Outcome Measure Information:

Title

Change in Quality of Life

Description

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.

Time Frame

One year

Secondary Outcome Measure Information:

Title

Incidence of complications

Description

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

Time Frame

Two years

Other Pre-specified Outcome Measures:

Title

Average marginal bone loss in the peri-implant zone

Time Frame

Two years

Title

Average of maximal bite force

Time Frame

Fifteen months

Title

Mini-implant survival rate

Time Frame

Two years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jorge Jofre, DDS, PhD

Organizational Affiliation

University of Concepcion

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Concepción

City

Concepción

State/Province

Región del Bio Bio

ZIP/Postal Code

4070420

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

22762359

Citation

Jofre J, Castiglioni X, Lobos CA. Influence of minimally invasive implant-retained overdenture on patients' quality of life: a randomized clinical trial. Clin Oral Implants Res. 2013 Oct;24(10):1173-7. doi: 10.1111/j.1600-0501.2012.02529.x. Epub 2012 Jul 4.

Results Reference

result

PubMed Identifier

21197490

Citation

Jofre J, Cendoya P, Munoz P. Effect of splinting mini-implants on marginal bone loss: a biomechanical model and clinical randomized study with mandibular overdentures. Int J Oral Maxillofac Implants. 2010 Nov-Dec;25(6):1137-44.

Results Reference

result

PubMed Identifier

20369095

Citation

Jofre J, Conrady Y, Carrasco C. Survival of splinted mini-implants after contamination with stainless steel. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):351-6.

Results Reference

result

PubMed Identifier

20070758

Citation

Jofre J, Hamada T, Nishimura M, Klattenhoff C. The effect of maximum bite force on marginal bone loss of mini-implants supporting a mandibular overdenture: a randomized controlled trial. Clin Oral Implants Res. 2010 Feb;21(2):243-9. doi: 10.1111/j.1600-0501.2009.01834.x.

Results Reference

result

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Randomized Study For Minimally Invasive Splinted Implants

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