<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043456</url>
  </required_header>
  <id_info>
    <org_study_id>28806032102395</org_study_id>
    <nct_id>NCT03043456</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction and Microbial Changes in Complete Dentures.</brief_title>
  <official_title>Evaluation of Patient Satisfaction and Microbiological Changes in Injectable Thermoplastic Resin and Conventional Acrylic Resin Complete Dentures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this research, the investigators are comparing the new thermoplastic material side by side&#xD;
      with the conventional poly methyl methacrylate for fully edentulous patients measuring their&#xD;
      satisfaction and microbiological count.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The restoration of masticatory function and aesthetics is an important aim in dentistry&#xD;
      mainly when patients present with extensive tooth loss. The loss of tooth in elderly patients&#xD;
      not only impairs the stomatognathic system but also their psychological status and quality of&#xD;
      life.so an important criteria's for the success of dentures are patient's expectations and&#xD;
      the ability of the denture to replace the lost masticatory efficiency.&#xD;
&#xD;
      The acrylic resin was first used in 1936; it was in that time the best alternative for&#xD;
      vulcanized rubber. Where it is characterized by superior characteristics and became the most&#xD;
      popular material used since then. Nonetheless, it has some problems such as polymerization&#xD;
      shrinkage, weak flexural, lower impact strength, and low fatigue resistance. These often lead&#xD;
      to denture failure during chewing or when fall out of the patient's hand. In order to enhance&#xD;
      some properties of PMMA, various efforts have been taken including addition of metal wires or&#xD;
      plates, fibers, metal inserts, and modification of chemical structure. In recent years, nylon&#xD;
      polymer has attracted attention as a denture base material.&#xD;
&#xD;
      Thermoplastic nylon like materials or polyamides were introduced and first used in dentistry&#xD;
      in 1950. The polyamide are uniquely characterized by high esthetics especially in removable&#xD;
      partial dentures, where retentive components are recommended anteriorly by this material&#xD;
      which provide high elasticity we can make the retentive components using the same material&#xD;
      and eliminate the metallic clasps.&#xD;
&#xD;
      Polyamides are characterized by low weight and flexibility make it more patient satisfactory&#xD;
      and fortunately it has no monomer remnants that may affect patient health and causes allergy.&#xD;
      Thermoplastic polyamides have almost no porosity which eliminates water sorption. The&#xD;
      technique used for its fabrication is injection molding technique which is more dimension&#xD;
      accurate than packing mold technique.&#xD;
&#xD;
      Valplast was initially used just over 50 years ago and has been used in modern dentistry&#xD;
      since the mid-fifties. A variation of nylon, which is far more flexible and stronger than&#xD;
      poly methyl methacrylate resin, is used in many alternative partial dentures. Valplast&#xD;
      flexible dentures are used for full sets of dentures especially in cases of acrylic allergy&#xD;
      which represent 20% of the population.&#xD;
&#xD;
      Comparative Evaluation of Impact and Flexural Strength is done to four types of Four&#xD;
      Commercially Available Flexible Denture Base Materials. Valplast had the maximum impact&#xD;
      strength, so these materials should be used in less undercut areas for long-term interim&#xD;
      removable partial dentures.&#xD;
&#xD;
      A study done by investigators who evaluated the surface roughness of four thermoplastic&#xD;
      (polyamide: Valplast, Lucitone FRS, polyethylene terephthalate: EstheShot, and polyester:&#xD;
      EstheShot Bright) and two conventional acrylic (Heat-polymerizing: Urban, and Pour type&#xD;
      auto-polymerizing: Pro-Cast DSP) denture bases by using scratch test. The results showed that&#xD;
      the surface of thermoplastic denture base resins was easily damaged compared with polymethyl&#xD;
      methacrylate which can cause discomfort to patients and also discoloration.&#xD;
&#xD;
      Complete Dentures Made with High Impact and Flexible Resins were evaluated. There was&#xD;
      statistically significant difference for masticatory performance in wet and dry weight values&#xD;
      of hard food, but there was no statistically significant difference for masticatory&#xD;
      performance in wet and dry weight values of soft food between the conventional and flexible&#xD;
      dentures. Though masticatory efficiency and performance were found to be better for patient's&#xD;
      dentures made with Polymethyl methacrylate (PMMA), a statistically significant number of&#xD;
      patients reported that the flexible dentures were more satisfying than the conventional&#xD;
      dentures.&#xD;
&#xD;
      Another study was done to evaluate the patients inflamatory response. patients received&#xD;
      acrylic complete denture were associated with significant high levels of proinflammatory&#xD;
      salivary cytokines (TNF-α and IL-6) in comparison to their corresponding levels in the&#xD;
      thermoplastic polyamide complete denture patients. The high levels of pro-inflammatory&#xD;
      salivary cytokines (TNF-α and IL-6) that were found in saliva of control group patients may&#xD;
      be linked to their protective effect against tissue inflammation caused by release of&#xD;
      residual monomer.&#xD;
&#xD;
      Adherence of Candida albicans to Flexible Denture Base Material was studied and concluded C.&#xD;
      albicans has lesser opportunities to adhere on flexible denture than on acrylic resin denture&#xD;
      base materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 1, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>prospective , parallel, randomized clinical trial</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The study will be blinded regarding the statistician who is responsible for data analysis.&#xD;
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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Patient satisfaction</measure>
    <time_frame>0 months , 3 months , 6 months</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in Microbial count</measure>
    <time_frame>0 months , 3 months , 6 months</time_frame>
    <description>CFU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Satisfaction</condition>
  <condition>Microbial Colonization</condition>
  <arm_group>
    <arm_group_label>Thermoplastic Resin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional acrylic resin group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Thermoplastic complete denture</intervention_name>
    <description>A device used to substitute the teeth for edentulous patients made of thermoplastic resin</description>
    <arm_group_label>Thermoplastic Resin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional acrylic resin complete denture</intervention_name>
    <description>A device used to substitute the teeth for edentulous patients made of acrylic resin</description>
    <arm_group_label>conventional acrylic resin group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Completely edentulous&#xD;
&#xD;
          -  No bone irregularities, no bone specules, mild to moderate undercut.&#xD;
&#xD;
          -  Good oral hygiene&#xD;
&#xD;
          -  Should be co-operative&#xD;
&#xD;
          -  No serious systemic disease&#xD;
&#xD;
          -  No TMJ Problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bone irregularities , soft tissue ulcerations , severe undercuts&#xD;
&#xD;
          -  Serious systemic problem&#xD;
&#xD;
          -  Patient with xerostomia&#xD;
&#xD;
          -  Severely resorbed ridge&#xD;
&#xD;
          -  Logistic or physical reasons that could affect follow-up,&#xD;
&#xD;
          -  Psychiatric problems&#xD;
&#xD;
          -  Medically compromised patients &amp; those with neuromascular disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amal A Rekaby, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Azza A Farahat, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed A Gazzar, MSc</last_name>
    <phone>00201001537371</phone>
    <email>gazar_fantasy@yahoo.com</email>
  </overall_contact>
  <reference>
    <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.</citation>
    <PMID>24298532</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23718997</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20339724</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18050582</PMID>
  </reference>
  <reference>
    <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.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16161124</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19135715</PMID>
  </reference>
  <reference>
    <citation>NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.</citation>
    <PMID>14785900</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>287797</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>6985962</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed Ahmed Abdel Hamid</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043456
org study id: 28806032102395
nct id: NCT03043456
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective , parallel, randomized clinical trial
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes 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.
measure: Changes in Patient satisfaction
time frame: 0 months , 3 months , 6 months
description: Questionnaire
measure: changes in Microbial count
time frame: 0 months , 3 months , 6 months
description: CFU
arm group label: Thermoplastic Resin group
arm group type: Active Comparator
description: Thermoplastic complete denture placement is done (Thermoplastic Comfort Systems, inc.)
arm group label: conventional acrylic resin group
arm group type: Placebo Comparator
description: Conventional acrylic resin complete denture placement is done. (Acrostone, inc.)
intervention type: Device
intervention name: Thermoplastic complete denture
description: A device used to substitute the teeth for edentulous patients made of thermoplastic resin
arm group label: Thermoplastic Resin group
intervention type: Device
intervention name: Conventional acrylic resin complete denture
description: A device used to substitute the teeth for edentulous patients made of acrylic resin
arm group label: conventional acrylic resin group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amal A Rekaby, Ph.D.
role: Study Chair
affiliation: Cairo University
last name: Azza A Farahat, Ph.D.
role: Study Director
affiliation: Cairo University
last name: Mohamed A Gazzar, MSc
phone: 00201001537371
email: gazar_fantasy@yahoo.com
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.
PMID: 24298532
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.
PMID: 23718997
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.
PMID: 20339724
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.
PMID: 18050582
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.
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.
PMID: 16161124
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.
PMID: 19135715
citation: NIRONEN P. Some possible uses for acrylic resins in dentistry. Odontol Tidskr. 1950;58(2):118-25. No abstract available.
PMID: 14785900
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.
PMID: 287797
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.
PMID: 6985962
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed Ahmed Abdel Hamid
investigator title: Dr.
mesh term: Communicable Diseases
mesh term: Infections
sharing ipd: No
ipd description: Data will be available through contact by email of the principle investigator. (gazar_fantasy@yahoo.com)