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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011842

Enrollment

Registered

2017-03-13

Start date

2015-01-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Edentulous maxilla

Interventions

Group 1: After successful healing of the implants within a period of 6 months, the patients will be allocated to one treatment group (anterior Locator =Option A) or (posterior Locator=OptionB). Then

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
The objective of this studie was to evaluate the masticatory performance in edentulous patients with Locator- attached overdentures. 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 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). The assesment will be after loding of the first implants and after 3 and 6 month.	—

Measure

Time frame

The objective of this studie was to evaluate the masticatory performance in edentulous patients with Locator- attached overdentures. 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 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). The assesment will be after loding of the first implants and after 3 and 6 month.

—

Secondary

Measure	Time frame
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. 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 . 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. All examinations will be assessed at baseline (loading of the implants), after 3 and after 6 month.	—

Measure

Time frame

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. 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 . 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. All examinations will be assessed at baseline (loading of the implants), after 3 and after 6 month.

—

Countries

Germany

Contacts

Public ContactStefanie Kappel

Poliklinik für zahnärztliche Prothetik, Universitätsklinikum Heidelberg

stefanie.kappel@med.uni-heidelberg.de0049 6221 566052

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026