Masticatory performance, maximum bite force and maximum mouth opening in patients treated with Biomet microfixation total joint prostheses: a cross-sectional study

Masticatory performance, maximum bite force and maximum mouth opening in patients treated with Biomet microfixation total joint prostheses: a cross-sectional study - Oral function in patients treated with a total joint prosthesis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46696

Enrollment

Registered

2018-04-24

Start date

2018-07-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Biomet microfixation total joint prosthesis jaw joint prosthesis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: (1) unilateral or bilateral total joint reconstruction of the temporomandibular joint (2) absence of postsurgical trauma (3) signed an informed consent

Exclusion criteria

Exclusion criteria: (1) edentate (2) patients who don*t speak and understand Dutch or English.

Design outcomes

Primary

Measure	Time frame
The masticatory performance will be measured by the mixing ability test. It measures how well a subject can mixe a red-blue wax tablet (size of a peppermint) by chewing on it.	—

Secondary

Measure	Time frame
(1) The bite force transducer will be used to measure the maximum bite force (MBF). (2) To measure the maximum active and passive range of motion of the jaw opening, participants will be asked to open their mouth to the maximum and all measured values will be recorded between the front teeth with a metal ruler. (3) The Visual Anologue Scale (VAS) will be used to assess the pain level from score 0 mm 'no pain' to score 100 mm 'worst imaginable pain'. Before measurements and during chewing, maximum bite force, and maximum mouth opening. (4) Patients satisfaction with the replacement will be determined using a VAS. This will be rated between 0 mm 'absolutely dissatisfied' and 100 'completely satisfied'. (5) To evaluate subjective impression of daily oral function the mandibular function impairment questionnaire (MFIQ) will be used.	—

Measure

Time frame

(1) The bite force transducer will be used to measure the maximum bite force (MBF). (2) To measure the maximum active and passive range of motion of the jaw opening, participants will be asked to open their mouth to the maximum and all measured values will be recorded between the front teeth with a metal ruler. (3) The Visual Anologue Scale (VAS) will be used to assess the pain level from score 0 mm 'no pain' to score 100 mm 'worst imaginable pain'. Before measurements and during chewing, maximum bite force, and maximum mouth opening. (4) Patients satisfaction with the replacement will be determined using a VAS. This will be rated between 0 mm 'absolutely dissatisfied' and 100 'completely satisfied'. (5) To evaluate subjective impression of daily oral function the mandibular function impairment questionnaire (MFIQ) will be used.

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Countries

Netherlands

Outcome results