This is a second or third phase, unicenter, prospective, parallel, double blind, randomized clinical trial. The aim of this study was to compare patient satisfaction with three types of denture occlusion. The sample size was 90 patients of the school of dentistry in Kermanshah university of medical sciences with the last tooth being extracted 3 month ago. Patients with mental problems and dissatisfied to keep on the study were removed. Patients were randomly allocated into 3 groups with stratified randomization method. In each group a set of complete dentures was made for each patient with an occlusal relation different from the other groups. The studied occlusions were: 1- bilateral balanced occlusion in which the most number of the teeth are in contact with all mandible movements, 2- lingualized occlusion in which just lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contact, 3- buccalized occlusion, the newfound occlusion in this study, in which just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth but the lingual cusps do not have any contact. After denture delivery and examinations after a day and a week, the satisfaction level of the patient was assessed at the end of month using a questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021326538N1
Registration date:2016-05-12, 1395/02/23
Registration timing:prospective
Last update:
Update count:1
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Hedaiat Moradpoor
Name of organization / entity
Kermanshah University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 6910
Email address
h.moradpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing satisfaction level of edentulous patients with bilateral balanced, lingualized and buccalized denture articulations
Public title
Comparing satisfaction level of edentulous patients by three types of occlusal scheme in complete denture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: edentulous patients; at least 3 month past from the last teeth extraction; no sever resorbed ridge; angle class 1 or mild class 2/3 jaw relation; signing the informed consent
Exclusion criteria: uncontrolled systemic disease; mental problems; unwillingness to keep on the study
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this double blind study patients and researchers were not aware of the details and method of randomization. Stratified randomization was used in this study as a method of randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Ethics Committee, Department of Research and Technology, Central Building, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
kums.rec.1394.324
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
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Making a set of complete denture with new Buccalized occlusion in that in this type of occlusion just buccal cusps of mandibular teeth are in contact with the central fossa of maxillary teeth whereas the lingual cusps do not have any contacts.
Category
Treatment - Other
2
Description
Making a set of complete denture with Lingualized occlusion in that in this type of occlusion lingual cusps of maxillary teeth are the only ones in contact with the central fossa of mandibular teeth but the buccal cusps do not have any contacts.
Category
Treatment - Other
3
Description
Making a set of complete denture with Balanced bilateral occlusion in that in this type of occlusion the most number of the tooth must be in contact at the all of mandible movement.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The school of Dentistry, Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzade
Street address
The school of Dentistry, Kermanshah University of Medical Sciences, kermanshah, Iran
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Vice Chancellor for Research Kermanshah University of Medical Sciences, Central building, Shahid Beheshti Boulevard, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzadeh
Position
Under graduated Student of Dentistry
Other areas of specialty/work
Street address
The school of Dentistry, shariati Street, Kermanshah
City
Kermanshah
Postal code
Phone
+98 837277030
Fax
Email
arabzade.m50@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hedayat Moradpour
Position
Prosthodontics Specialist
Other areas of specialty/work
Street address
Department of Prosthodontics, The school of Dentistry, Kermanshah University of Medical Sciences , Iran
City
Kermanshah
Postal code
Phone
+98 83 3729 6910
Fax
Email
h.moradpour@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohaddese Arabzadeh
Position
Under graduated Student of Dentistry
Other areas of specialty/work
Street address
City
Kermanshah
Postal code
Phone
Fax
Email
arabzade.m50@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)