Randomized Study For Minimally Invasive Splinted Implants

Jaw, Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02107612
• Other study ID #: FONDEF V09E0007
• 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

• Jaw, Edentulous

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