Comparative Study Between Acrylic and Flexible Dentures

July 19, 2017 updated by: Marianne Azer, Cairo University

Comparative Study of Conventional Versus Flexible Mandibular Single Complete Denture

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

17

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

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: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytological changes manifested as keratinization index
Time Frame: 6 months
Objective Outcome: measuring the cytological changes manifested as keratinization index
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Essam Aziz, professor, supervisor

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)

September 1, 2017

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

June 2, 2017

First Submitted That Met QC Criteria

June 11, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • evidence committee

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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