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

Primary Purpose

Edentulous

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
zero degree teeth
anatomic teeth
Sponsored by
Haixin Qian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • complete edentulism for at least three months class Ⅳ ridge

Exclusion Criteria:

  • neuromuscular dysfunction, psychiatric disorder,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Zero-Degree Teeth, then Anatomic Teeth

    Anatomic Teeth, then Zero-Degree Teeth

    Arm 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

    Outcomes

    Primary Outcome Measures

    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".
    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".

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 23, 2015
    Last Updated
    May 1, 2015
    Sponsor
    Haixin Qian
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02359955
    Brief Title
    Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
    Official Title
    Comparison of Masticatory Efficiency and EMG Activity Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2014 (undefined)
    Primary Completion Date
    May 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Haixin Qian

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Edentulous

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Zero-Degree Teeth, then Anatomic Teeth
    Arm Type
    Experimental
    Arm Description
    edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
    Arm Title
    Anatomic Teeth, then Zero-Degree Teeth
    Arm Type
    Experimental
    Arm Description
    edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
    Intervention Type
    Device
    Intervention Name(s)
    zero degree teeth
    Intervention Description
    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
    Intervention Type
    Device
    Intervention Name(s)
    anatomic teeth
    Intervention Description
    when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture
    Primary Outcome Measure Information:
    Title
    EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
    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
    Title
    EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months)
    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
    Secondary Outcome Measure Information:
    Title
    Masticatory Efficiency Index
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: complete edentulism for at least three months class Ⅳ ridge Exclusion Criteria: neuromuscular dysfunction, psychiatric disorder,

    12. IPD Sharing Statement

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