NCT02359955

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

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

April 9, 2015

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Last Updated

May 20, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

January 23, 2015

Results QC Date

March 7, 2015

Last Update Submit

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

EXPERIMENTAL

edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture

Device: zero degree teethDevice: anatomic teeth

Anatomic Teeth, then Zero-Degree Teeth

EXPERIMENTAL

edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture

Device: zero degree teethDevice: anatomic teeth

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

Anatomic Teeth, then Zero-Degree TeethZero-Degree Teeth, then 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

Anatomic Teeth, then Zero-Degree TeethZero-Degree Teeth, then Anatomic Teeth

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

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