Trial Outcomes & Findings for Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge (NCT NCT02359955)

Results Overview

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".

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

three months

Results posted on

2015-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Zero-degree Teeth, Then Anatomic Teeth edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture	Anatomic Teeth, Then Zero-degree Teeth edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=10 Participants 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	Group 2 n=10 Participants 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	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	58.9 years STANDARD_DEVIATION 5.9 • n=5 Participants	58.4 years STANDARD_DEVIATION 5.29 • n=7 Participants	58.65 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Group 1 Zero Degree Teeth n=20 Participants edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture	Group 2 Anatomic Teeth n=20 Participants edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture	Group 1 Anatomic Teeth n=20 Participants	Group 2 Zero Degree Teeth n=20 Participants
EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)	0.72 microvolts Standard Deviation 0.53	0.87 microvolts Standard Deviation 0.49	1.07 microvolts Standard Deviation 0.66	1.21 microvolts Standard Deviation 1.00

PRIMARY outcome

Timeframe: three month

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".

Outcome measures

Outcome measures
Measure	Group 1 Zero Degree Teeth n=20 Participants edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture	Group 2 Anatomic Teeth n=20 Participants edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture	Group 1 Anatomic Teeth n=20 Participants	Group 2 Zero Degree Teeth n=20 Participants
EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)	247 millisecond Standard Deviation 72	314 millisecond Standard Deviation 82	306 millisecond Standard Deviation 114	368 millisecond Standard Deviation 102

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 Zero Degree Teeth n=10 Participants edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture	Group 2 Anatomic Teeth n=10 Participants edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture	Group 1 Anatomic Teeth n=10 Participants	Group 2 Zero Degree Teeth n=10 Participants
Masticatory Efficiency Index	0.327 index score Standard Deviation 0.0714	0.334 index score Standard Deviation 0.072	0.3364 index score Standard Deviation 0.0996	0.329 index score Standard Deviation 0.0862

Adverse Events

Zero Degree Teeth,Then Anatomic Teeth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Anatomic Teeth, Then Zero-degree Teeth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Haixin Qian

Shanghai No. 9 People's Hospital

Phone: 13501961651

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place