Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 6407 for:    zero

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02359955
Recruitment Status : Unknown
Verified May 2015 by Haixin Qian, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2015
Results First Posted : April 9, 2015
Last Update Posted : May 20, 2015
Sponsor:
Information provided by (Responsible Party):
Haixin Qian, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Edentulous
Interventions Device: zero degree teeth
Device: anatomic teeth
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Zero-degree Teeth, Then Anatomic Teeth Anatomic Teeth, Then Zero-degree Teeth
Hide Arm/Group Description edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Group 1 Group 2 Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
58.9  (5.9) 58.4  (5.29) 58.65  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
5
  50.0%
11
  55.0%
Male
4
  40.0%
5
  50.0%
9
  45.0%
1.Primary Outcome
Title EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Amp Value of Right Masseter of Zero Degree Teeth Amp Value of Left Masseter of Zero Degree Teeth Amp Value of Right Master of Anatomic Teeth Amp Value of Left Masseter of Anatomic Teeth
Hide Arm/Group Description:
emg parameter of edentulous patients treated with zero-degree teeth complete denture
[Not Specified]
emg parameter of patients treated with anatomic teeth complete denture
[Not Specified]
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: microvolts
0.72  (0.53) 0.87  (0.49) 1.07  (0.66) 1.21  (1.00)
2.Primary Outcome
Title EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Duration of Right Masseter of Zero Degree Teeth Duration of Left Masseter of Zero Degree Teeth Duration of Right Masster of Anatomic Teeth Duration of Left Masseter of Anatomic Teeth
Hide Arm/Group Description:
emg parameter of patients treated with zero degree teeth
[Not Specified]
emg parameter of patients treated with anatomic teeth complete denture
[Not Specified]
Overall Number of Participants Analyzed 20 20 20 20
Mean (Standard Deviation)
Unit of Measure: millisecond
247  (72) 314  (82) 306  (114) 368  (102)
3.Secondary Outcome
Title Masticatory Efficiency Index
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Zero Degree Teeth Group 2 Anatomic Teeth Group 1 Anatomic Teeth Group 2 Zero Degree Teeth
Hide Arm/Group Description:
edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: index score
0.327  (0.0714) 0.334  (0.072) 0.3364  (0.0996) 0.329  (0.0862)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zero Degree Teeth,Then Anatomic Teeth Anatomic Teeth, Then Zero-degree Teeth
Hide Arm/Group Description edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
All-Cause Mortality
Zero Degree Teeth,Then Anatomic Teeth Anatomic Teeth, Then Zero-degree Teeth
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zero Degree Teeth,Then Anatomic Teeth Anatomic Teeth, Then Zero-degree Teeth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zero Degree Teeth,Then Anatomic Teeth Anatomic Teeth, Then Zero-degree Teeth
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Haixin Qian
Organization: Shanghai No. 9 People's Hospital
Phone: 13501961651
EMail: drqian8167@126.com
Layout table for additonal information
Responsible Party: Haixin Qian, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02359955     History of Changes
Other Study ID Numbers: 201395
First Submitted: January 23, 2015
First Posted: February 10, 2015
Results First Submitted: March 7, 2015
Results First Posted: April 9, 2015
Last Update Posted: May 20, 2015