<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/NCT03234803</url>
  </required_header>
  <id_info>
    <org_study_id>polyamide_complete dentures</org_study_id>
    <nct_id>NCT03234803</nct_id>
  </id_info>
  <brief_title>Measuring Quality of Life of Poly-amide Complete Dentures</brief_title>
  <official_title>Metal-reinforced Flexible Poly-amide Complete Denture Versus Heat-cured Poly-methyl Methacrylate in Terms of Oral Health Related Quality of Life; Randomized Clinical Trial</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>
      Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base&#xD;
      material because of its several advantages as; good esthetics, adequate strength, easy repair&#xD;
      and simple processing techniques. As any material it has some problems as polymerization&#xD;
      shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was&#xD;
      introduced into dentistry to be used as a denture base material in order to solve these&#xD;
      problems. Polyamide denture base materials have some superior properties than PMMA as; High&#xD;
      impact &amp; flexural strength, excellent esthetics and less release of residual monomers4.&#xD;
      Although being an advantage from the point of patient satisfaction, flexural property&#xD;
      considered to be a contraindication for a denture base material.&#xD;
&#xD;
      The invistigators' trial is done in order to improve rigidity of a polyamide material as well&#xD;
      as to improve oral health related quality of life in comparison to heat cured polymethyl&#xD;
      methacrylate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oral health related quality of life</measure>
    <time_frame>one month</time_frame>
    <description>OHIP-49 questionnaire</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">18</enrollment>
  <condition>Denture, Complete</condition>
  <arm_group>
    <arm_group_label>poly-amide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>poly-methyl methacrylate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>poly-amide</intervention_name>
    <description>new denture base material</description>
    <arm_group_label>poly-amide</arm_group_label>
    <other_name>Nylon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>poly-methyl methacrylate</intervention_name>
    <description>gold standard for denture base materials</description>
    <arm_group_label>poly-methyl methacrylate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - i. Male or female patient with age range (45-55) and in good medical condition ii. All&#xD;
        patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient&#xD;
        inter-arch distance.&#xD;
&#xD;
        iii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency&#xD;
        of masticatory muscles.&#xD;
&#xD;
        iv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal&#xD;
        diseases were not included.&#xD;
&#xD;
        ii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue&#xD;
        behavior and/or size. iv. No intraoral soft and hard tissue pathosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amr Nasr, DDS</last_name>
    <phone>01285247060</phone>
    <email>denamr12@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maha El Kerdawy</last_name>
  </overall_contact_backup>
  <reference>
    <citation>Ali IL, Yunus N, Abu-Hassan MI. Hardness, flexural strength, and flexural modulus comparisons of three differently cured denture base systems. J Prosthodont. 2008 Oct;17(7):545-9. doi: 10.1111/j.1532-849X.2008.00357.x. Epub 2008 Aug 26.</citation>
    <PMID>18761582</PMID>
  </reference>
  <reference>
    <citation>Wadachi J, Sato M, Igarashi Y. Evaluation of the rigidity of dentures made of injection-molded materials. Dent Mater J. 2013;32(3):508-11. doi: 10.4012/dmj.2013-061.</citation>
    <PMID>23719015</PMID>
  </reference>
  <reference>
    <citation>Schwindling FS, Rammelsberg P, Stober T. Effect of chemical disinfection on the surface roughness of hard denture base materials: a systematic literature review. Int J Prosthodont. 2014 May-Jun;27(3):215-25. doi: 10.11607/ijp.3759.</citation>
    <PMID>24905261</PMID>
  </reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 27, 2017</last_update_submitted>
  <last_update_submitted_qc>July 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amr Magdy Ibrahim</investigator_full_name>
    <investigator_title>Internal resident at removable prosthodontic department</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03234803
org study id: polyamide_complete dentures
nct id: NCT03234803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base
      material because of its several advantages as; good esthetics, adequate strength, easy repair
      and simple processing techniques. As any material it has some problems as polymerization
      shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was
      introduced into dentistry to be used as a denture base material in order to solve these
      problems. Polyamide denture base materials have some superior properties than PMMA as; High
      impact & flexural strength, excellent esthetics and less release of residual monomers4.
      Although being an advantage from the point of patient satisfaction, flexural property
      considered to be a contraindication for a denture base material.

      The invistigators' trial is done in order to improve rigidity of a polyamide material as well
      as to improve oral health related quality of life in comparison to heat cured polymethyl
      methacrylate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: oral health related quality of life
time frame: one month
description: OHIP-49 questionnaire
arm group label: poly-amide
arm group type: Experimental
description: poly-amide is a thermoplastic material recently introduced to be used as a complete denture material, that provide excellent aesthetics and flexibility.
arm group label: poly-methyl methacrylate
arm group type: Active Comparator
description: poly-methyl methacrylate has been commonly used as a material for constructing complete dentures and proved to have high success rate and considered to be gold standard.
intervention type: Other
intervention name: poly-amide
description: new denture base material
arm group label: poly-amide
other name: Nylon
intervention type: Other
intervention name: poly-methyl methacrylate
description: gold standard for denture base materials
arm group label: poly-methyl methacrylate
criteria: 
gender: All
minimum age: 45 Years
maximum age: 55 Years
healthy volunteers: No
last name: Amr Nasr, DDS
phone: 01285247060
email: denamr12@gmail.com
last name: Maha El Kerdawy
citation: Ali IL, Yunus N, Abu-Hassan MI. Hardness, flexural strength, and flexural modulus comparisons of three differently cured denture base systems. J Prosthodont. 2008 Oct;17(7):545-9. doi: 10.1111/j.1532-849X.2008.00357.x. Epub 2008 Aug 26.
PMID: 18761582
citation: Wadachi J, Sato M, Igarashi Y. Evaluation of the rigidity of dentures made of injection-molded materials. Dent Mater J. 2013;32(3):508-11. doi: 10.4012/dmj.2013-061.
PMID: 23719015
citation: Schwindling FS, Rammelsberg P, Stober T. Effect of chemical disinfection on the surface roughness of hard denture base materials: a systematic literature review. Int J Prosthodont. 2014 May-Jun;27(3):215-25. doi: 10.11607/ijp.3759.
PMID: 24905261
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amr Magdy Ibrahim
investigator title: Internal resident at removable prosthodontic department
sharing ipd: Undecided