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Trial record 8 of 6376 for:    zero

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

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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

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.

Condition or disease Intervention/treatment Phase
Edentulous Device: zero degree teeth Device: anatomic teeth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2014
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: Zero-Degree Teeth, then Anatomic Teeth
edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
Device: 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

Device: 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

Experimental: Anatomic Teeth, then Zero-Degree Teeth
edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
Device: 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

Device: 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




Primary Outcome Measures :
  1. EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) [ Time Frame: 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".

  2. EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) [ Time Frame: 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".


Secondary Outcome Measures :
  1. Masticatory Efficiency Index [ Time Frame: 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • complete edentulism for at least three months class Ⅳ ridge

Exclusion Criteria:

  • neuromuscular dysfunction, psychiatric disorder,

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Responsible Party: Haixin Qian, fellow, clinic research, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02359955     History of Changes
Other Study ID Numbers: 201395
First Posted: February 10, 2015    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: May 20, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases