EdentulousNCT02359955
Comparison of Masticatory Efficiency Between Complete Denture With Zero-degree Teeth and Anatomic Teeth in Patients With Severely Resorbed Ridge
A study testing zero degree teeth and anatomic teeth in people with Edentulous, run by Haixin Qian.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Edentulous
- What is being tested?
- zero degree teeth and anatomic teeth
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- complete edentulism for at least three months class Ⅳ ridge
Who cannot join
- neuromuscular dysfunction, psychiatric disorder,
About this study
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
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.
- Conditions
- Edentulous
- Being tested
- zero degree teeth, anatomic teeth
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zero degree teethDevice
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 teethDevice
when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: zero degree teeth; Device: 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 Receives: Device: zero degree teeth; Device: anatomic teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: three month
Secondary outcomes (1)
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haixin Qian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haixin Qian, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359955
- Sponsor's protocol ID
- 201395
- Status last verified
- May 2015
- First submitted
- 23 Jan 2015
- Last updated
- 20 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02359955
- Acronym / sponsor ID
- 201395
- Conditions
- Edentulous
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Haixin QianUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Posted 9 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zero-Degree Teeth, then Anatomic Teeth | Experimental | Device: zero degree teeth, Device: anatomic teethedentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture |
| Anatomic Teeth, then Zero-Degree Teeth | Experimental | Device: zero degree teeth, Device: anatomic teethedentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- complete edentulism for at least three months class Ⅳ ridge
Key exclusion criteria (1 listed)
- neuromuscular dysfunction, psychiatric disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zero degree teethzero 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, then Zero-Degree Teeth, Zero-Degree Teeth, then Anatomic Teeth |
| anatomic teethwhen anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture | Device | Anatomic Teeth, then Zero-Degree Teeth, Zero-Degree Teeth, then Anatomic Teeth |
Primary outcome
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".
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".
1 secondary outcome
Masticatory Efficiency Index
Time frame: three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing zero degree teeth and anatomic teeth in people with Edentulous, run by Haixin Qian.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG (Masseters EMG Are Recorded After Patient Wears Complete Denture for Three Months) (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.