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Retention of Metal Reinforced Polyamide Denture Base and Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03385746
Recruitment Status : Unknown
Verified December 2017 by Ahmed Mostafa Hassan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : December 28, 2017
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mostafa Hassan, Cairo University

Brief Summary:
The trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases

Condition or disease Intervention/treatment Phase
Anodontia of Permanent Dentition Other: polyamide Other: heat cured acrylic resin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Retention of Metal Reinforced Polyamide Denture Base Compared to Conventional Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 1, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: polyamide
metal reinforced polyamide denture base material
Other: polyamide
metal reinforced polyamide denture base material
Other Name: Nylon

Active Comparator: heat cured acrylic resin
conventional heat cured acrylic resin denture base
Other: heat cured acrylic resin
conventional heat cured acrylic resin denture base material




Primary Outcome Measures :
  1. Retention assessed by digital forcemeter [ Time Frame: 6 weeks ]
    Retention of mandibular denture



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
  2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
  3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  4. Free from any tempro-mandibular disease.
  5. Good oral hygiene.

Exclusion Criteria:

  1. Neuromuscular disorder and orofacial disease.
  2. Tempromandibular joint and muscle pain
  3. xerostomia or excessive salivation.
  4. Limited mouth opening

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): NCT03385746


Contacts
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Contact: Ahmed Mostafa, B.D.S 00201111839610 a7medostafa7assan@gmail.com
Contact: Amal Kaddah

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Ahmed Mostafa Hassan, Dentist, Cairo University
ClinicalTrials.gov Identifier: NCT03385746    
Other Study ID Numbers: re inforced complete denture
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: December 28, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anodontia
Tooth Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Congenital Abnormalities