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Comparative Study Between Acrylic and Flexible Dentures

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ClinicalTrials.gov Identifier: NCT03184883
Recruitment Status : Unknown
Verified June 2017 by Marianne Azer, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Marianne Azer, Cairo University

Brief Summary:
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction

Condition or disease Intervention/treatment Phase
Health Knowledge, Attitudes, Practice Procedure: single conventional denture Procedure: single flexible denture Not Applicable

Detailed Description:
comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue by keratinization index through PAP stain and patient's satisfaction through a questionnaire

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: single conventional denture
patients with mandibular edentulous arch by using acrylic resin denture with soft linner
Procedure: single conventional denture
mandibular conventional denture with soft liner

Active Comparator: single flexible denture
patients with mandibular edentulous arch by using flexible lower denture
Procedure: single flexible denture
mandibular flexible compete denture




Primary Outcome Measures :
  1. Cytological changes manifested as keratinization index [ Time Frame: 6 months ]
    Objective Outcome: measuring the cytological changes manifested as keratinization index



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mandibular flat ridge
  2. Patient with opposing natural teeth or satisfactory fixed prostheses
  3. Angle class I Maxillimandibular relationship
  4. No intraoral soft and hard tissue pathosis
  5. Non smokers
  6. Patients with no previous denture experience
  7. Patients having last extraction at least 6 month before denture construction

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03184883


Contacts
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Contact: Marianne Azer, Bachelor 01227243531 marianne.fouad@dentistry.cu.edu.eg
Contact: Ahmed Fayad, lecturer 01005185211

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Essam Aziz, professor supervisor
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Responsible Party: Marianne Azer, Comparative Study of Conventional versus Flexible Mandibular Single Complete Denture, Cairo University
ClinicalTrials.gov Identifier: NCT03184883    
Other Study ID Numbers: evidence committee
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No