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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02107612
Other study ID # FONDEF V09E0007
Secondary ID
Status Completed
Phase N/A
First received April 4, 2014
Last updated April 8, 2014
Start date July 2004
Est. completion date July 2007

Study information

Verified date April 2014
Source University of Concepcion, Chile
Contact n/a
Is FDA regulated No
Health authority Chile: Instituto de Salud Pública de ChileChile: Comisión Nacional de Investigación Científica y Tecnológica
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date July 2007
Est. primary completion date April 2006
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 90 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Other:
Denture


Locations

Country Name City State
Chile University of Concepción Concepción Región del Bio Bio

Sponsors (2)

Lead Sponsor Collaborator
University of Concepcion, Chile Public Health Service of Chile

Country where clinical trial is conducted

Chile, 

References & 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 — View 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. — View Citation

Jofré 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. — View Citation

Jofré 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.1600-05 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Average marginal bone loss in the peri-implant zone Two years No
Other Average of maximal bite force Fifteen months No
Other Mini-implant survival rate Two years No
Primary 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 No
Secondary Incidence of complications Complications: infection, implant failure, presence of signs and symptoms of peri-implant mucositis. Two years Yes
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