Clinical trail to evaluate the masticatory performance in patients with a Locator® supported overdenture of the maxilla according to implant position and number.

Not Applicable

Conditions: Edentulous maxilla

Registration Number: DRKS00011842

Lead Sponsor: ITI Headquarters

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 25

Inclusion Criteria

The inclusion criteria will be: male and female adults, decleration for agreement, adapted two implant-supported mandibular denture,
edentulous maxilla with adapted complete denture, wish of patient to receive four implants in the
anterior and posterior region of the maxilla, adequate vertical or horizontal bone dimensions and
quality. Alternatives, costs and pro- and contra has to be explained by a dentist and the participant has to decide against all alternatives.

Exclusion Criteria

Exclusion criteria will be: missing declaration of agreement, intend of moving to an other city, drug or alcohol abuse, inadequate vertical or horizontal
bone dimensions and bone quality. Patients who, during the healing period, lost one or more
implants that could not be successfully replaced will also be excluded.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this studie was to evaluate the masticatory performance in edentulous patients with Locator- attached overdentures.<br><br>Masticatory performance will be assessed on the basis of the ability of the subjects to comminute standardized artificial test food (cubes from modified dental-impression silicone Optosil=Optocal) at their habitual chewing frequency. The chewed sample will <br>then be disinfected, scanned with a flatbed scanner, and processed by use of the validated image- analysis in accordance with a standardized procedure (Eberhard et al. 2011).<br>The assesment will be after loding of the first implants and after 3 and 6 month.

Secondary Outcome Measures

Name	Time	Method
Beside the masticatory performance changes of oral heath related quality of life, evaluated by use of the Oral health Impact Profile (OHIP), will be recorded.<br>Furthermore, masticatory muscle activity with two or four implants will be assessed by use of electromyography (EMG). Complications and aftercare of the implants and dentures will also be recorded .<br>Beside this Parameters the patient expectations about the prosthetic restoration and self-assessment of chewing ability will be assessed by questionnaires. The taste accuracy with and without palate resin will be recorded by use of questionnaires.<br>All examinations will be assessed at baseline (loading of the implants), after 3 and after 6 month.<br>