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Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture

Primary Purpose

Edentulous

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
buccalized occlusion
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous focused on measuring Lingualized occlusion, Complete denture occlusion, Fully bilateral balanced occlusion, Patient satisfaction of complete denture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Prosthodontics, Faculty of Dentistry, Medical University of IsfahanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Denture, edentulous patient, treatment

Denture, Edentulous patient, treatment

Arm Description

Dentures with different type of occlusion

Dentures with different type of occlusion

Outcomes

Primary Outcome Measures

Patients' Satisfaction
method of measurement is Questionair

Secondary Outcome Measures

Patients' Dissatisfaction
method of measurement Examination and Questionair

Full Information

First Posted
December 12, 2011
Last Updated
December 17, 2011
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01493232
Brief Title
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Official Title
Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous
Keywords
Lingualized occlusion, Complete denture occlusion, Fully bilateral balanced occlusion, Patient satisfaction of complete denture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Denture, edentulous patient, treatment
Arm Type
Experimental
Arm Description
Dentures with different type of occlusion
Arm Title
Denture, Edentulous patient, treatment
Arm Type
Experimental
Arm Description
Dentures with different type of occlusion
Intervention Type
Other
Intervention Name(s)
buccalized occlusion
Other Intervention Name(s)
K06.9, Disorder of gingiva and edentulous alveolar ridge, unspecified
Intervention 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.
Primary Outcome Measure Information:
Title
Patients' Satisfaction
Description
method of measurement is Questionair
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Patients' Dissatisfaction
Description
method of measurement Examination and Questionair
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Javad Shirani, Under graduated Student
Phone
00989356039479
Email
javaad.sh_f@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin Mosharraf, Prosthodontics Specialist
Organizational Affiliation
Medical University of Isfahan
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan
City
Isfehan
ZIP/Postal Code
81745-319
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Javad Shirani, Under graduated Student
Phone
00989356039479
Email
javaad.sh_f@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammad Javad Shirani, Under graduated Student

12. IPD Sharing Statement

Citations:
PubMed Identifier
24138344
Citation
Shirani M, Mosharraf R, Shirany M. Comparisons of patient satisfaction levels with complete dentures of different occlusions: a randomized clinical trial. J Prosthodont. 2014 Jun;23(4):259-66. doi: 10.1111/jopr.12101. Epub 2013 Oct 19.
Results Reference
derived
Links:
URL
http://researches.mui.ac.ir
Description
Department of Research and Technology, Medical University of Isfahan, Iran

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Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture

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