NCT02107612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
Last Updated

April 9, 2014

Status Verified

April 1, 2014

Enrollment Period

1.8 years

First QC Date

April 4, 2014

Last Update Submit

April 8, 2014

Conditions

Jaw, Edentulous

Keywords

Mini-Dental ImplantImplant-Supported Dental ProsthesisMinimally Invasive Surgical proceduresOverdenturesAged

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (1)

  • Incidence of complications

    Two years

Other Outcomes (3)

  • Average marginal bone loss in the peri-implant zone

    Two years

  • Average of maximal bite force

    Fifteen months

  • Mini-implant survival rate

    Two years

Study Arms (2)

Integrated system to insert two splinted (bar) miniimplants

EXPERIMENTAL

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

Denture

ACTIVE COMPARATOR

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

Interventions

Integrated system to insert two splinted (bar) mini dental implants for mandibular overdentureDEVICE
Also known as: Easy2Fix
Integrated system to insert two splinted (bar) miniimplants
DentureOTHER
Denture

Eligibility Criteria

Age45 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Concepción

Concepción, Región Del Bio Bio, 4070420, Chile

Location

Related Publications (4)

  • 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.

    PMID: 22762359RESULT

  • 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.

    PMID: 21197490RESULT

  • 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.

    PMID: 20369095RESULT

  • 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.

    PMID: 20070758RESULT

MeSH Terms

Conditions

Jaw, Edentulous

Interventions

Dental ImplantsDentures

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jorge Jofre, DDS, PhD

    University of Concepcion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jorge Jofre DDs, PhD

Study Record Dates

First Submitted

April 4, 2014

First Posted

April 8, 2014

Study Start

July 1, 2004

Primary Completion

April 1, 2006

Study Completion

July 1, 2007

Last Updated

April 9, 2014

Record last verified: 2014-04

Locations

CL(1)