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Patient Satisfaction and Microbial Changes in Complete Dentures.

Primary Purpose

Satisfaction, Microbial Colonization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermoplastic complete denture
Conventional acrylic resin complete denture
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Satisfaction

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Thermoplastic Resin group

    conventional acrylic resin group

    Arm Description

    Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)

    Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)

    Outcomes

    Primary Outcome Measures

    Changes in Patient satisfaction
    Questionnaire

    Secondary Outcome Measures

    changes in Microbial count
    CFU

    Full Information

    First Posted
    January 31, 2017
    Last Updated
    February 7, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03043456
    Brief Title
    Patient Satisfaction and Microbial Changes in Complete Dentures.
    Official Title
    Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2017 (Anticipated)
    Primary Completion Date
    August 1, 2017 (Anticipated)
    Study Completion Date
    September 1, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Satisfaction, Microbial Colonization

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective , parallel, randomized clinical trial
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    The study will be blinded regarding the statistician who is responsible for data analysis. The participant patients will be blinded. The outcome assessor for patient satisfaction can be blinded during the questionnaire. On the other hand, Microbial count assessor will not be blinded during swab taking while the lab technician can be blinded. but The operator cannot be blinded.
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Thermoplastic Resin group
    Arm Type
    Active Comparator
    Arm Description
    Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
    Arm Title
    conventional acrylic resin group
    Arm Type
    Placebo Comparator
    Arm Description
    Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)
    Intervention Type
    Device
    Intervention Name(s)
    Thermoplastic complete denture
    Intervention Description
    A device used to substitute the teeth for edentulous patients made of thermoplastic resin
    Intervention Type
    Device
    Intervention Name(s)
    Conventional acrylic resin complete denture
    Intervention Description
    A device used to substitute the teeth for edentulous patients made of acrylic resin
    Primary Outcome Measure Information:
    Title
    Changes in Patient satisfaction
    Description
    Questionnaire
    Time Frame
    0 months , 3 months , 6 months
    Secondary Outcome Measure Information:
    Title
    changes in Microbial count
    Description
    CFU
    Time Frame
    0 months , 3 months , 6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed A Gazzar, MSc
    Phone
    00201001537371
    Email
    gazar_fantasy@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Amal A Rekaby, Ph.D.
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Azza A Farahat, Ph.D.
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)
    Citations:
    PubMed Identifier
    24298532
    Citation
    Singh K, Aeran H, Kumar N, Gupta N. Flexible thermoplastic denture base materials for aesthetical removable partial denture framework. J Clin Diagn Res. 2013 Oct;7(10):2372-3. doi: 10.7860/JCDR/2013/5020.3527. Epub 2013 Oct 5.
    Results Reference
    background
    PubMed Identifier
    23718997
    Citation
    Osada H, Shimpo H, Hayakawa T, Ohkubo C. Influence of thickness and undercut of thermoplastic resin clasps on retentive force. Dent Mater J. 2013;32(3):381-9. doi: 10.4012/dmj.2012-284.
    Results Reference
    background
    PubMed Identifier
    20339724
    Citation
    Goiato MC, Santos DM, Haddad MF, Pesqueira AA. Effect of accelerated aging on the microhardness and color stability of flexible resins for dentures. Braz Oral Res. 2010 Jan-Mar;24(1):114-9. doi: 10.1590/s1806-83242010000100019.
    Results Reference
    background
    PubMed Identifier
    18050582
    Citation
    Samet N, Tau S, Findler M, Susarla SM, Findler M. Flexible, removable partial denture for a patient with systemic sclerosis (scleroderma) and microstomia: a clinical report and a three-year follow-up. Gen Dent. 2007 Nov-Dec;55(6):548-51.
    Results Reference
    background
    Citation
    León BL, Del Bel Cury AA, Rodrigues Garcia RC. Loss of residual monomer from resilient lining materials processed by different methods. Rev Odontol Ciêc. 2008;23:215-9.
    Results Reference
    background
    PubMed Identifier
    16161124
    Citation
    Bayraktar G, Guvener B, Bural C, Uresin Y. Influence of polymerization method, curing process, and length of time of storage in water on the residual methyl methacrylate content in dental acrylic resins. J Biomed Mater Res B Appl Biomater. 2006 Feb;76(2):340-5. doi: 10.1002/jbm.b.30377.
    Results Reference
    background
    PubMed Identifier
    19135715
    Citation
    Urban VM, Machado AL, Vergani CE, Giampaolo ET, Pavarina AC, de Almeida FG, Cass QB. Effect of water-bath post-polymerization on the mechanical properties, degree of conversion, and leaching of residual compounds of hard chairside reline resins. Dent Mater. 2009 May;25(5):662-71. doi: 10.1016/j.dental.2008.10.017. Epub 2009 Jan 10.
    Results Reference
    background
    PubMed Identifier
    14785900
    Citation
    NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.
    Results Reference
    background
    PubMed Identifier
    287797
    Citation
    Giunta JL, Grauer I, Zablotsky N. Allergic contact stomatitis caused by acrylic resin. J Prosthet Dent. 1979 Aug;42(2):188-90. doi: 10.1016/0022-3913(79)90173-2. No abstract available.
    Results Reference
    background
    PubMed Identifier
    6985962
    Citation
    Weaver RE, Goebel WM. Reactions to acrylic resin dental prostheses. J Prosthet Dent. 1980 Feb;43(2):138-42. doi: 10.1016/0022-3913(80)90176-6.
    Results Reference
    background

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