- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03385746
Retention of Metal Reinforced Polyamide Denture Base and Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture
December 21, 2017 updated by: Ahmed Mostafa Hassan, Cairo University
Evaluation of Retention of Metal Reinforced Polyamide Denture Base Compared to Conventional Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed Mostafa, B.D.S
- Phone Number: 00201111839610
- Email: a7medostafa7assan@gmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition
- Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance.
- Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
- Free from any tempro-mandibular disease.
- Good oral hygiene.
Exclusion Criteria:
- Neuromuscular disorder and orofacial disease.
- Tempromandibular joint and muscle pain
- xerostomia or excessive salivation.
- Limited mouth opening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: polyamide
metal reinforced polyamide denture base material
|
metal reinforced polyamide denture base material
Other Names:
|
ACTIVE_COMPARATOR: heat cured acrylic resin
conventional heat cured acrylic resin denture base
|
conventional heat cured acrylic resin denture base material
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention assessed by digital forcemeter
Time Frame: 6 weeks
|
Retention of mandibular denture
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Vojdani M, Giti R. Polyamide as a Denture Base Material: A Literature Review. J Dent (Shiraz). 2015 Mar;16(1 Suppl):1-9.
- Soygun K, Bolayir G, Boztug A. Mechanical and thermal properties of polyamide versus reinforced PMMA denture base materials. J Adv Prosthodont. 2013 May;5(2):153-60. doi: 10.4047/jap.2013.5.2.153. Epub 2013 May 30.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
February 1, 2018
Primary Completion (ANTICIPATED)
May 1, 2018
Study Completion (ANTICIPATED)
July 1, 2018
Study Registration Dates
First Submitted
December 21, 2017
First Submitted That Met QC Criteria
December 21, 2017
First Posted (ACTUAL)
December 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 28, 2017
Last Update Submitted That Met QC Criteria
December 21, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- re inforced complete denture
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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