Patient Satisfaction and Microbial Changes in Complete Dentures.

February 7, 2017 updated by: Mohamed Ahmed Abdel Hamid, Cairo University

Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures

In this research, the investigators are comparing the new thermoplastic material side by side with the conventional poly methyl methacrylate for fully edentulous patients measuring their satisfaction and microbiological count.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The restoration of masticatory function and aesthetics is an important aim in dentistry mainly when patients present with extensive tooth loss. The loss of tooth in elderly patients not only impairs the stomatognathic system but also their psychological status and quality of life.so an important criteria's for the success of dentures are patient's expectations and the ability of the denture to replace the lost masticatory efficiency.

The acrylic resin was first used in 1936; it was in that time the best alternative for vulcanized rubber. Where it is characterized by superior characteristics and became the most popular material used since then. Nonetheless, it has some problems such as polymerization shrinkage, weak flexural, lower impact strength, and low fatigue resistance. These often lead to denture failure during chewing or when fall out of the patient's hand. In order to enhance some properties of PMMA, various efforts have been taken including addition of metal wires or plates, fibers, metal inserts, and modification of chemical structure. In recent years, nylon polymer has attracted attention as a denture base material.

Thermoplastic nylon like materials or polyamides were introduced and first used in dentistry in 1950. The polyamide are uniquely characterized by high esthetics especially in removable partial dentures, where retentive components are recommended anteriorly by this material which provide high elasticity we can make the retentive components using the same material and eliminate the metallic clasps.

Polyamides are characterized by low weight and flexibility make it more patient satisfactory and fortunately it has no monomer remnants that may affect patient health and causes allergy. Thermoplastic polyamides have almost no porosity which eliminates water sorption. The technique used for its fabrication is injection molding technique which is more dimension accurate than packing mold technique.

Valplast was initially used just over 50 years ago and has been used in modern dentistry since the mid-fifties. A variation of nylon, which is far more flexible and stronger than poly methyl methacrylate resin, is used in many alternative partial dentures. Valplast flexible dentures are used for full sets of dentures especially in cases of acrylic allergy which represent 20% of the population.

Comparative Evaluation of Impact and Flexural Strength is done to four types of Four Commercially Available Flexible Denture Base Materials. Valplast had the maximum impact strength, so these materials should be used in less undercut areas for long-term interim removable partial dentures.

A study done by investigators who evaluated the surface roughness of four thermoplastic (polyamide: Valplast, Lucitone FRS, polyethylene terephthalate: EstheShot, and polyester: EstheShot Bright) and two conventional acrylic (Heat-polymerizing: Urban, and Pour type auto-polymerizing: Pro-Cast DSP) denture bases by using scratch test. The results showed that the surface of thermoplastic denture base resins was easily damaged compared with polymethyl methacrylate which can cause discomfort to patients and also discoloration.

Complete Dentures Made with High Impact and Flexible Resins were evaluated. There was statistically significant difference for masticatory performance in wet and dry weight values of hard food, but there was no statistically significant difference for masticatory performance in wet and dry weight values of soft food between the conventional and flexible dentures. Though masticatory efficiency and performance were found to be better for patient's dentures made with Polymethyl methacrylate (PMMA), a statistically significant number of patients reported that the flexible dentures were more satisfying than the conventional dentures.

Another study was done to evaluate the patients inflamatory response. patients received acrylic complete denture were associated with significant high levels of proinflammatory salivary cytokines (TNF-α and IL-6) in comparison to their corresponding levels in the thermoplastic polyamide complete denture patients. The high levels of pro-inflammatory salivary cytokines (TNF-α and IL-6) that were found in saliva of control group patients may be linked to their protective effect against tissue inflammation caused by release of residual monomer.

Adherence of Candida albicans to Flexible Denture Base Material was studied and concluded C. albicans has lesser opportunities to adhere on flexible denture than on acrylic resin denture base materials.

Study Type

Interventional

Enrollment (Anticipated)

24

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completely edentulous
  • No bone irregularities, no bone specules, mild to moderate undercut.
  • Good oral hygiene
  • Should be co-operative
  • No serious systemic disease
  • No TMJ Problems

Exclusion Criteria:

  • Bone irregularities , soft tissue ulcerations , severe undercuts
  • Serious systemic problem
  • Patient with xerostomia
  • Severely resorbed ridge
  • Logistic or physical reasons that could affect follow-up,
  • Psychiatric problems
  • Medically compromised patients & those with neuromascular disorders

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thermoplastic Resin group
Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
Device: Thermoplastic complete denture
A device used to substitute the teeth for edentulous patients made of thermoplastic resin
Placebo Comparator: conventional acrylic resin group
Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)
Device: Conventional acrylic resin complete denture
A device used to substitute the teeth for edentulous patients made of acrylic resin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Patient satisfaction
Time Frame: 0 months , 3 months , 6 months
Questionnaire
0 months , 3 months , 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in Microbial count
Time Frame: 0 months , 3 months , 6 months
CFU
0 months , 3 months , 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Amal A Rekaby, Ph.D., Cairo University
  • Study Director: Azza A Farahat, Ph.D., 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)

March 1, 2017

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

January 31, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28806032102395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)

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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