Edentulous
Conditions
Brief summary
This study aims to evaluate masticatory efficiency of the zero-degree teeth complete denture in treatment of edentulous patients of severely resorbed ridge.Patients will be crossed over to be treated with zero-degree teeth complete denture and anatomic teeth complete denture. For each patient, the masticatory efficiency and electromyography with different denture will be recorded and analysis.
Interventions
DEVICEzero degree teeth
zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
DEVICEanatomic teeth
when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture
Sponsors
Haixin Qian
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* complete edentulism for at least three months class Ⅳ ridge
Exclusion criteria
* neuromuscular dysfunction, psychiatric disorder,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | three months | the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Masticatory Efficiency Index | three months | the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture | 10 |
| Group 2 edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 58.9 years STANDARD_DEVIATION 5.9 | 58.4 years STANDARD_DEVIATION 5.29 | 58.65 years STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration,amplitude is reported here as the average value from 20 chewing strokes in units of microvolts.
Time frame: three months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Zero Degree Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 0.72 microvolts | Standard Deviation 0.53 |
| Group 2 Anatomic Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 0.87 microvolts | Standard Deviation 0.49 |
| Group 1 Anatomic Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 1.07 microvolts | Standard Deviation 0.66 |
| Group 2 Zero Degree Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 1.21 microvolts | Standard Deviation 1 |
Primary
EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
the masseters EMG are recorded after patient wears complete denture for three months,EMGs of masseters of 20 chewing strokes were recorded in term of value of amp and duration, duration here is reporteds the average value from 20 chewing strokes in units of millisecond.
Time frame: three month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Zero Degree Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 247 millisecond | Standard Deviation 72 |
| Group 2 Anatomic Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 314 millisecond | Standard Deviation 82 |
| Group 1 Anatomic Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 306 millisecond | Standard Deviation 114 |
| Group 2 Zero Degree Teeth | EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) | 368 millisecond | Standard Deviation 102 |
Secondary
Masticatory Efficiency Index
the masticatory efficiency is tested after patient wears complete denture for three months,each patient was given 4 gram dry peanuts, chewed for 20 seconds, then spat in the receptacle and rinsed mouth residue. The peanut particles were diluted to 1000 ml with distilled water, stirred for 1 minutes and standing for 2 minutes to suspension. Absorbance values(av) were measured at the wavelength of 590nm in a spectrophotometer. The higher the masticatory efficiency, the smaller the peanut particles, then the higher the av value, vice versa. Value of av was used to represent masticatory efficiency. For each patient, the test was conducted three times, and the average value of av was taken as the final result. A lower masticatory efficiency index indicates larger peanut particle size observed.
Time frame: three months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 Zero Degree Teeth | Masticatory Efficiency Index | 0.327 index score | Standard Deviation 0.0714 |
| Group 2 Anatomic Teeth | Masticatory Efficiency Index | 0.334 index score | Standard Deviation 0.072 |
| Group 1 Anatomic Teeth | Masticatory Efficiency Index | 0.3364 index score | Standard Deviation 0.0996 |
| Group 2 Zero Degree Teeth | Masticatory Efficiency Index | 0.329 index score | Standard Deviation 0.0862 |