Protocol summary
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Study aim
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The aim of this study was to compare patient satisfaction with four types of denture occlusion.
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Design
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En In this study, 120 patients edentulous and criteria of the study referred to dental school Kermanshah are selected . The participants were randomly selected. The test was carried out in Phase2-3.
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Settings and conduct
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En Patients referring to Kermanshah Dentistry School are classified in four group.In each group a set of complete dentures was made for each patient. 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.4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of 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.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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
4-canin guidance occlusion teeth are arranged that during side movements there is contact only on worker side of canine and premolar teeth and molar teeth of worker side and all teeth of balance side are out of contact.
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Main outcome variables
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En Increasing patients' satisfaction and obtaining more complete information about this occlusion to increase the performance of artificial teeth.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2016021326538N1
Registration date:
2016-05-12, 1395/02/23
Registration timing:
registered_while_recruiting
Last update:
2018-01-05, 1396/10/15
Update count:
1
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Registration date
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2016-05-12, 1395/02/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Kermanshah University of Medical Sciences
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Expected recruitment start date
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2015-09-27, 1394/07/05
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Expected recruitment end date
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2017-11-11, 1396/08/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing satisfaction level of edentulous patients with bilateral balanced, lingualized and buccalized denture articulations and canine guidance nonbalanced denture articulations
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Public title
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Comparing satisfaction level of edentulous patients by four types of occlusal scheme in complete denture
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old to 80 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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En The sampling method is simplified randomly. A line is generated and 120 people are randomly selected by numbers. According to Cochran's formula, a probability error of 5% was calculated for a sample size of 120.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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En 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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2017-09-06, 1396/06/15
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Ethics committee reference number
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IR.KUMS.REC.1396.300
Health conditions studied
1
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Description of health condition studied
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Edentulous
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ICD-10 code
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k06.9
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ICD-10 code description
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Disorder of gingiva and edentulous alveolar ridge, unspecified
Primary outcomes
1
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Description
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Patients' Satisfaction
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Timepoint
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After 1 Month
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
3
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Description
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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.
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Category
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Treatment - Other
4
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Description
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Making a set of complete denture with canine guidance occlusion that can be contacted during sidewalks only on the side of the worker of the canines and the molars, and the molar teeth of the worker side and all the teeth on the balancing side are out of.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kermanshah University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available