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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

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date July 21, 2017
Estimated Study Start Date  ICMJE September 1, 2017
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2017)
Cytological changes manifested as keratinization index [ Time Frame: 6 months ]
Objective Outcome: measuring the cytological changes manifested as keratinization index
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study Between Acrylic and Flexible Dentures
Official Title  ICMJE Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture
Brief Summary comparing the effect of conventional mandibular single denture with flexible mandibular single denture on tissue and patient's satisfaction
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Health Knowledge, Attitudes, Practice
Intervention  ICMJE
  • Procedure: single conventional denture
    mandibular conventional denture with soft liner
  • Procedure: single flexible denture
    mandibular flexible compete denture
Study Arms  ICMJE
  • Experimental: single conventional denture
    patients with mandibular edentulous arch by using acrylic resin denture with soft linner
    Intervention: Procedure: single conventional denture
  • Active Comparator: single flexible denture
    patients with mandibular edentulous arch by using flexible lower denture
    Intervention: Procedure: single flexible denture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2017)
17
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2017
Estimated Primary Completion Date October 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184883
Other Study ID Numbers  ICMJE evidence committee
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marianne Azer, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Essam Aziz, professor supervisor
PRS Account Cairo University
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP