Randomized Study For Minimally Invasive Splinted Implants

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02107612

Enrollment

Registered

2014-04-08

Start date

2004-07-31

Completion date

2007-07-31

Last updated

2014-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaw, Edentulous

Keywords

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

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.

Interventions

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

OTHERDenture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Other

Measure	Time frame
Average marginal bone loss in the peri-implant zone	Two years
Average of maximal bite force	Fifteen months
Mini-implant survival rate	Two years

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026