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

This study is currently recruiting participants.
Verified December 2011 by Isfahan University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Mohammad Javad Shirani, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01493232
First received: December 12, 2011
Last updated: December 17, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Edentulous
 Other: buccalized occlusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Patient Satisfaction & Stress Distribution on Mandibular Ridge by Three Posterior Occlusal Scheme in Complete Denture

Resource links provided by NLM:

MedlinePlus related topics: Dentures
U.S. FDA Resources

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Patients' Satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    method of measurement is Questionair


Secondary Outcome Measures:
  • Patients' Dissatisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    method of measurement Examination and Questionair


Estimated Enrollment: 15
Study Start Date: October 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denture, edentulous patient, treatment
Dentures with different type of occlusion
 Other: buccalized 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:
  • K06.9
  • Disorder of gingiva and edentulous alveolar ridge, unspecified
Experimental: Denture, Edentulous patient, treatment
Dentures with different type of occlusion
 Other: buccalized 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:
  • K06.9
  • Disorder of gingiva and edentulous alveolar ridge, unspecified

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493232

Contacts
Contact: Mohammad Javad Shirani, Under graduated Student 00989356039479 javaad.sh_f@yahoo.com

Locations
Iran, Islamic Republic of
Department of Prosthodontics, Faculty of Dentistry, Medical University of Isfahan Recruiting
Isfehan, Iran, Islamic Republic of, 81745-319
Contact: Mohammad Javad Shirani, Under graduated Student     00989356039479     javaad.sh_f@yahoo.com    
Principal Investigator: Mohammad Javad Shirani, Under graduated Student            
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Chair: Ramin Mosharraf, Prosthodontics Specialist Medical University of Isfahan
  More Information

Additional Information:
Department of Research and Technology, Medical University of Isfahan, Iran  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Mohammad Javad Shirani, Mohammad Javad Shirani, Isfahan University of Medical Sciences, Faculty of dentistry,Dnt.mui.ac.ir, Perincipal investigator, Dental student., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01493232     History of Changes
Other Study ID Numbers: 190052, IRCT201110097749N1
Study First Received: December 12, 2011
Last Updated: December 17, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
Lingualized occlusion
Complete denture occlusion
Fully bilateral balanced occlusion
Patient satisfaction of complete denture

Additional relevant MeSH terms:
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on May 21, 2013