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

May 1, 2015 updated by: Haixin Qian

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • complete edentulism for at least three months class Ⅳ ridge

Exclusion Criteria:

  • neuromuscular dysfunction, psychiatric disorder,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
three months
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".
three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haixin Qian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 10, 2015

Study Record Updates

Last Update Posted (Estimate)

May 20, 2015

Last Update Submitted That Met QC Criteria

May 1, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201395

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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