- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493232
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
December 17, 2011 updated by: Mohammad Javad Shirani, Isfahan University of Medical Sciences
In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampling of 15 participant that will be signed informed consent and their latest teeth was extracted 3 month ago, will be selected.
For each participant, it will be made 3 set of complete dentures that are variable in occlusion only.
During the study, dissatisfied participants can leave it.
Each set will be inserted for 1month in 5 participant randomly.
The participants will be examined in two stages, after a day and after a week.
At the end of month the questionaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors.
Then the second and third denture will be inserted simultaneously.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Isfehan, Iran, Islamic Republic of, 81745-319
- Recruiting
- Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan
-
Contact:
- Mohammad Javad Shirani, Under graduated Student
- Phone Number: 00989356039479
- Email: javaad.sh_f@yahoo.com
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Principal Investigator:
- Mohammad Javad Shirani, Under graduated Student
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- edentulous patients
- at least 3 month ago the latest teeth was extracted
- ideal jaw relation
- signing the informed consent
Exclusion Criteria:
- uncontrolled systemic disease
- mentally problem
- dissatisfaction for keeping on the study
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
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Denture, edentulous patient, treatment
Dentures with different type of occlusion
|
Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country.
In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.
Other Names:
|
|
EXPERIMENTAL: Denture, Edentulous patient, treatment
Dentures with different type of occlusion
|
Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country.
In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' Satisfaction
Time Frame: 1 year
|
method of measurement is Questionair
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' Dissatisfaction
Time Frame: 1 year
|
method of measurement Examination and Questionair
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ramin Mosharraf, Prosthodontics Specialist, Medical University of Isfahan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2011
Primary Completion (ANTICIPATED)
March 1, 2012
Study Completion (ANTICIPATED)
May 1, 2012
Study Registration Dates
First Submitted
December 12, 2011
First Submitted That Met QC Criteria
December 14, 2011
First Posted (ESTIMATE)
December 15, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 20, 2011
Last Update Submitted That Met QC Criteria
December 17, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190052
- IRCT201110097749N1 (OTHER_GRANT: Medical Uuniversity of Isfehan 1244003)
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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