Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture

January 4, 2018 updated by: Mahmoud Abdallah Abdelmottaleb, Cairo University

Evaluation Of Chewing Efficiency Of Metal-Reinforced PolyAmide Denture Base In Comparison To Conventional Heat Cured Acrylic Resin Denture Base For Mandibular Complete Denture (A Randomized Clinical Trial)

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)

38

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.

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:

  1. Male or female patient with age range (45-55) completely edentulous and in good medical condition.
  2. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient interarch distance.
  3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.
  4. Free from any tempro-mandibular joint disorder.
  5. The patients have good oral hygiene.
  6. The edentulous ridges should be covered by firm healthy mucosa.
  7. Healthy and co-operative patients.

Exclusion Criteria:

  1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
  2. Previous history of radiotherapy or chemotherapy.
  3. Any skeletal problem dictates surgical intervention.
  4. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.
  5. Patient with xerostomia or excessive salivation.
  6. No intraoral soft and hard tissue pathosis.
  7. Psychiatric problems.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: reinforced polyamide denture base
metal reinforced polyamide denture base
Other: polyamide
metal reinforced polyamide denture base material
Other Names:
  • nylon
Active Comparator: conventional acrylic resin denture base
conventional heat cured acrylic resin denture base
Other: heat cured acrylic resin
conventional heat cured acrylic resin denture base material

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
chewing efficiency assessed using sieving method
Time Frame: 6 weeks
chewing efficiency of the mandibular complete denture
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

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

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 29, 2017

First Submitted That Met QC Criteria

January 4, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 4, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reinforced 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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