Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at below P25 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 23, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedResults Posted
Study results publicly available
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedMay 20, 2015
May 1, 2015
11 months
January 23, 2015
March 7, 2015
May 1, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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".
three months
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".
three month
Secondary Outcomes (1)
Masticatory Efficiency Index
three months
Study Arms (2)
Zero-Degree Teeth, then Anatomic Teeth
EXPERIMENTALedentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
Anatomic Teeth, then Zero-Degree Teeth
EXPERIMENTALedentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
Interventions
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
when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture
Eligibility Criteria
You may qualify if:
- complete edentulism for at least three months class â…£ ridge
You may not qualify if:
- neuromuscular dysfunction, psychiatric disorder,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Haixin Qianlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Haixin Qian
- Organization
- Shanghai No. 9 People's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- fellow, clinic research
Study Record Dates
First Submitted
January 23, 2015
First Posted
February 10, 2015
Study Start
June 1, 2014
Primary Completion
May 1, 2015
Last Updated
May 20, 2015
Results First Posted
April 9, 2015
Record last verified: 2015-05