<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/NCT03253510</url>
  </required_header>
  <id_info>
    <org_study_id>Poly-amide complete dentures</org_study_id>
    <nct_id>NCT03253510</nct_id>
  </id_info>
  <brief_title>Measuring Biting Force of Poly-amide Complete Dentures</brief_title>
  <official_title>Comparison Between Biting Force of Heat Cured Poly Methylmethacrylate and Metal Reinforced Polyamide for Mandibular Complete Denture</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>
      Randomized clinical trial to compare between biting force of mandibular complete denture&#xD;
      constructed from two different materials; metal reinforced polyamide and conventional&#xD;
      PMMA,The null hypothesis of the study that there will not be a difference between biting&#xD;
      force of the complete denture constructed from metal reinforced polyamide and PMMA&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and&#xD;
      chemical resistance and the exceedingly rare allergy response. Although flexural strength,&#xD;
      modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively&#xD;
      low, they demonstrate great impact strength, toughness, and resistance to fracture. It was&#xD;
      suggested that by adding glass fibers to polyamides, their stiffness and other mechanical&#xD;
      properties could be increased. The flexural properties of nylon denture base materials has&#xD;
      promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities,&#xD;
      tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and&#xD;
      PMMA when used as a denture base material and concluded that; the modulus of elasticity of&#xD;
      polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they&#xD;
      recommended that polyamide to be used as a denture base material it should be reinforced with&#xD;
      metal frame&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2017</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>
    <intervention_model_description>Participants are assigned to two more groups in parallel for the duration of the study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biting force</measure>
    <time_frame>One month</time_frame>
    <description>Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Complete Edentulism</condition>
  <arm_group>
    <arm_group_label>Poly-amide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>new thermoplastic material used as a denture base, that has excellent ethetics 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>Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Poly-amide</intervention_name>
    <description>New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response</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 denture base material</description>
    <arm_group_label>poly-methyl methacrylate</arm_group_label>
    <other_name>PMMA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patient with age range from fifty five to sixty five completely&#xD;
             edentulous and in good medical condition&#xD;
&#xD;
          2. Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient&#xD;
             inter arch distance.&#xD;
&#xD;
          3. Free from any systemic or neuromuscular disorder that might affect chewing efficiency&#xD;
             of masticatory muscles.&#xD;
&#xD;
          4. Free from any tempro-mandibular disease.&#xD;
&#xD;
          5. Good oral hygiene&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Neuromuscular disorder and orofacial disease.&#xD;
&#xD;
          2. Tempromandibular joint and muscle pain&#xD;
&#xD;
          3. xerostomia or excessive salivation.&#xD;
&#xD;
          4. Limited mouth opening&#xD;
&#xD;
          5. Abnormal tongue behavior and/or size.&#xD;
&#xD;
          6. Intraoral soft and hard tissue pathosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hadeer Abdel hadi Abd elhameed, master</last_name>
    <phone>01158834401</phone>
    <email>hadeerhadi1990@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>nadia abbas</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hadeer Hadi</name>
      <address>
        <city>Cairo</city>
        <zip>002</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>hadeer abdelhadi abdelhameed, master</last_name>
      <phone>01158834401</phone>
      <email>hadeerhadi1990@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hadeer Hadi</investigator_full_name>
    <investigator_title>Master degree candidate at removable prosthodontic department, Cairou</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/NCT03253510
org study id: Poly-amide complete dentures
nct id: NCT03253510
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Randomized clinical trial to compare between biting force of mandibular complete denture
      constructed from two different materials; metal reinforced polyamide and conventional
      PMMA,The null hypothesis of the study that there will not be a difference between biting
      force of the complete denture constructed from metal reinforced polyamide and PMMA
Polyamide resins used in dentistry exhibit high flexibility, physical strength, heat and
      chemical resistance and the exceedingly rare allergy response. Although flexural strength,
      modulus of elasticity and rigidity of nylon (polyamide) denture base materials are relatively
      low, they demonstrate great impact strength, toughness, and resistance to fracture. It was
      suggested that by adding glass fibers to polyamides, their stiffness and other mechanical
      properties could be increased. The flexural properties of nylon denture base materials has
      promoted their usage only in conditions like unyielding undercuts, pronounced tuberosities,
      tori and bulging alveolar ridges. In 2013 Wadachi etal compared rigidity of polyamide and
      PMMA when used as a denture base material and concluded that; the modulus of elasticity of
      polyamide was very low in comparison to PMMA and was lower than ISO standard, and so they
      recommended that polyamide to be used as a denture base material it should be reinforced with
      metal frame
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to two more groups in parallel for the duration of the study
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Biting force
time frame: One month
description: Bite force will be measured for both types of complete denture after one month of denture insertion . The recorded force during maximal clenching was obtained with I-load sensor placed between pairs of opposing teeth at one side and wood tongue depressor at the other side. The meter and depressor were located at the area of premolar/molar where there is more number of occlusal contacts with strong determinant of muscle action and subsequent great bite force.
arm group label: Poly-amide
arm group type: Experimental
description: new thermoplastic material used as a denture base, that has excellent ethetics and flexibility
arm group label: poly-methyl methacrylate
arm group type: Active Comparator
description: Polymethylmethacrylate is one of the most widely used denture base material, because of its good biocompatibility, reliability and dimensional stability
intervention type: Other
intervention name: Poly-amide
description: New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response
arm group label: Poly-amide
other name: Nylon
intervention type: Other
intervention name: Poly-methyl methacrylate
description: Gold standard denture base material
arm group label: poly-methyl methacrylate
other name: PMMA
criteria: 
gender: All
minimum age: 45 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hadeer Abdel hadi Abd elhameed, master
phone: 01158834401
email: hadeerhadi1990@gmail.com
last name: nadia abbas
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hadeer Hadi
investigator title: Master degree candidate at removable prosthodontic department, Cairou
sharing ipd: Undecided