In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampeling of 15 participent that will be signed informed consent and theire latest teeth was extracted 3 month ago, will be selected. For each participent, it will be maded 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participents can leave it.
In this randomized clinical trial to compare the patients' satisfaction of complete dentures with different occlusal forms, after simple randomized sampeling of 15 participent that will be signed informed consent and theire latest teeth was extracted 3 month ago, will be selected. For each participent, it will be maded 3 set of complete dentures that are variable in occlusion only. During the study, dissatisfied participents can leave it. Each set will be inserted for 1month in 5 participent randomly. The participents will be examined in two stages, after a day and after a week. At the end of month the questinaire will be filled out and the pressure under the mandibular denture base will be measured with the pressure sensors in invitro study. Then the second and third denture will be inserted simultaneousely.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110097749N1
Registration date:2011-11-04, 1390/08/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-04, 1390/08/13
Registrant information
Name
ramin mosharraf
Name of organization / entity
university
Country
Iran (Islamic Republic of)
Phone
+98 31 1624 8238
Email address
mosharraf@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical University of Isfehan
Expected recruitment start date
2011-10-31, 1390/08/09
Expected recruitment end date
2012-03-29, 1391/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Public title
Comparing Patient Satisfaction & Stress Distribution on lower jaw by Three Posterior Teeth Closure Scheme in Complete Denture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion citeria: edentulous patients ; atleast 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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Regional Bioethics Committee
Street address
Department of Research and Technology, Building number4, central organ of university, Medical Uuniversity of Isfehan, Iran
City
Isfehan
Postal code
81745-319
Approval date
2011-09-26, 1390/07/04
Ethics committee reference number
190052
Health conditions studied
1
Description of health condition studied
Edentulous
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
Description
Patients' Satisfaction
Timepoint
After 1 month
Method of measurement
Questionair
2
Description
Pressure Ditribution Under Mandibular Denture Bases
Timepoint
After 1 month
Method of measurement
Pressure sensor
Secondary outcomes
1
Description
Pateints' Dissatisfaction
Timepoint
During the Study
Method of measurement
Examination and Questionair
Intervention groups
1
Description
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.
Category
Other
2
Description
Making a set of complete denture with lingualized Occlusion that is different from current occlusion in my country. This type are using in japan. In this type just lingual casps of maxillary teeth will be connect to the central fossa of mandibular teeth and buccal casps have not contact.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Prosthodontics in Faculty of Dentistry of Medical University of Isfahan
Full name of responsible person
Mohammad Javad Shirani
Street address
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan, Iran
City
Isfehan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Doctor Fallah
Street address
Department of Research and Technology, Building number4, central organ of university, Medical Uuniversity of Isfehan, Iran
City
Isfehan
Grant name
دانشگاه علوم پزشکی اصفهان 1244003
Grant code / Reference number
190052
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Medical University of Isfahan
Full name of responsible person
Mohammad Javad Shirani
Position
Under graduated Student of Dentistry
Other areas of specialty/work
Street address
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan, Iran
City
Isfehan
Postal code
81745-319
Phone
+98 38 2422 5600
Fax
+98 31 1668 7898
Email
javaad.sh_f@yahoo.com
Web page address
www.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical University of Isfahan
Full name of responsible person
Ramin Mosharraf
Position
Prosthodontics Specialist
Other areas of specialty/work
Street address
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan, Iran
City
Isfehan
Postal code
81745-319
Phone
+98 31 1624 8238
Fax
+98 31 1624 8238
Email
mosharraf@dnt.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Medical University of Isfehan
Full name of responsible person
Mohammad Javad Shirani
Position
Under graduated Student of Dentistry
Other areas of specialty/work
Street address
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan, Iran
City
Isfehan
Postal code
81745-319
Phone
+98 38 2422 5600
Fax
+98 31 1668 7898
Email
javaad.sh_f@yahoo.com
Web page address
www.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)