<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/NCT03025555</url>
  </required_header>
  <id_info>
    <org_study_id>1987</org_study_id>
    <nct_id>NCT03025555</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction and Dimensional Accuracy of Bre Flex and Peek for Removable Partial Dentures</brief_title>
  <official_title>COMPARISON OF PATIENT SATISFACTION AND DIMENSIONAL ACCURACY OF INJECTION MOLDED PEEK AND BRE-FLEX MATERIALS FOR BOUNDED REMOVABLE PARTIAL DENTURES (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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation the patient satisfaction and dimensional stability of upper removable partial&#xD;
      denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The assessor is responsible for all clinical procedure that will be conducted in this study&#xD;
      during all the visits:&#xD;
&#xD;
      Panoramic radiograph and periapical radiographs will be made on the prospected abutment teeth&#xD;
      to evaluate the crown-root ratio, the apical condition of the abutment and their alveolar&#xD;
      bone support.&#xD;
&#xD;
      The preliminary impression will be performed with irreversible hydro-colloid impression&#xD;
      material (alginate), The impressions will be poured with type IV dental stone to obtain&#xD;
      diagnostic casts. Maxillary Face-bow will be recorded. The diagnostic casts will be mounted&#xD;
      on semi adjustable articulator in centric occluding relation to evaluate the interarch&#xD;
      distance and occlusal plane.&#xD;
&#xD;
      Special trays will be constructed and Mouth preparation will be performed by preparing&#xD;
      guiding planes and rests seats will be prepared opposing to the edentulous area. Final&#xD;
      impression will be taken by elastomeric impression material. The impression will be poured&#xD;
      into type IV dental stone in order to obtain master cast. The master cast will be surveyed.&#xD;
      The proposed design will be as follows: metal framework base saddle for edentulous areas on&#xD;
      both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention.&#xD;
      The denture base will be tried in with acrylic teeth in patient's mouth. After that, the&#xD;
      denture base of the partial denture will be processed incorporation with the metal framework&#xD;
      into the two different materials to be evaluated. The first group will receive the partial&#xD;
      denture in which the metal framework incorporated with the denture base fabricated from PEEK&#xD;
      material. The second group will receive the partial denture in which the metal framework&#xD;
      incorporated with the denture base material fabricated from BRE-FLEX.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 30, 2017</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">August 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>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>1 month</time_frame>
    <description>The first week at the time of insertion measuring patient satisfaction immediately after partial denture insertion, The third week measuring patient satisfaction of the partial denture, The fourth week measuring patient satisfaction of the partial denture.&#xD;
the patient satisfaction is measured by questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>dimensional stability</measure>
    <time_frame>1 month</time_frame>
    <description>The first week at the time of insertion measuring the dimensional stability immediately after partial denture insertion.&#xD;
The third week measuring the dimensional stability of the partial denture,The fourth week measuring the dimensional stability of the partial denture.&#xD;
dimensional stability is measured by digital caliper.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will receive partial denture constructed from breflex material.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will receive partial denture constructed from PEEK material.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEEK</intervention_name>
    <description>Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years but recently used as removable prosthetic material. Advantages of this polymer material are elimination of allergic reactions, high polishing qualities, low plaque affinity, and good wear resistance.&#xD;
It has been proven that it shows high mechanical and biological properties. Studies evaluating the properties of this material are limited and need more clinical tests.</description>
    <arm_group_label>group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bre.flex</intervention_name>
    <description>Bre.flex is a nylon-based thermoplastic material, composed of nylon PA 12 (polyamide).Nylon exhibits high physical strength, heat resistance and chemical resistance. It can be easily modified to increase stiffness and wear resistance. Nylon resin can be semi-translucent and provides excellent esthetics but it is a little more difficult to adjust and polish.</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients must have Kennedy class III modification I upper partially edentulous&#xD;
             ridges.&#xD;
&#xD;
          -  The remaining teeth have good periodontal condition, with no signs of attrition or&#xD;
             gingival recession.&#xD;
&#xD;
          -  Male or female patient with age range (45-55) and in good medical condition&#xD;
&#xD;
          -  All patients have skeletal Angle's class I maxillo-mandibular relationship and have&#xD;
             sufficient interarch distance.&#xD;
&#xD;
          -  Free from any systemic or neuromuscular disorder that might affect chewing efficiency&#xD;
             of masticatory muscles.&#xD;
&#xD;
          -  Free from any tempro-mandibular joint disorder.&#xD;
&#xD;
          -  The patients have good oral hygiene and low caries index.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having abnormal habits as bruxism or clenching&#xD;
&#xD;
          -  Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal&#xD;
             diseases were not included.&#xD;
&#xD;
          -  Teeth with compromised bone support.&#xD;
&#xD;
          -  Patient with xerostomia or excessive salivation.&#xD;
&#xD;
          -  Patient with abnormal tongue behavior and/or size.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sylvia Sami Melek Ekladios</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>nylon</keyword>
  <keyword>polyamide</keyword>
  <keyword>PEEK</keyword>
  <keyword>partial denture</keyword>
  <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/NCT03025555
org study id: 1987
nct id: NCT03025555
lead sponsor: 
has dmc: Yes
Evaluation the patient satisfaction and dimensional stability of upper removable partial
      denture constructed from two different flexible thermoplastic materials.(BRE-FLEX and PEEK).
The assessor is responsible for all clinical procedure that will be conducted in this study
      during all the visits:

      Panoramic radiograph and periapical radiographs will be made on the prospected abutment teeth
      to evaluate the crown-root ratio, the apical condition of the abutment and their alveolar
      bone support.

      The preliminary impression will be performed with irreversible hydro-colloid impression
      material (alginate), The impressions will be poured with type IV dental stone to obtain
      diagnostic casts. Maxillary Face-bow will be recorded. The diagnostic casts will be mounted
      on semi adjustable articulator in centric occluding relation to evaluate the interarch
      distance and occlusal plane.

      Special trays will be constructed and Mouth preparation will be performed by preparing
      guiding planes and rests seats will be prepared opposing to the edentulous area. Final
      impression will be taken by elastomeric impression material. The impression will be poured
      into type IV dental stone in order to obtain master cast. The master cast will be surveyed.
      The proposed design will be as follows: metal framework base saddle for edentulous areas on
      both sides connected with palatal strap. Aker's clasp on all abutments with buccal retention.
      The denture base will be tried in with acrylic teeth in patient's mouth. After that, the
      denture base of the partial denture will be processed incorporation with the metal framework
      into the two different materials to be evaluated. The first group will receive the partial
      denture in which the metal framework incorporated with the denture base fabricated from PEEK
      material. The second group will receive the partial denture in which the metal framework
      incorporated with the denture base material fabricated from BRE-FLEX.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: patient satisfaction
time frame: 1 month
description: The first week at the time of insertion measuring patient satisfaction immediately after partial denture insertion, The third week measuring patient satisfaction of the partial denture, The fourth week measuring patient satisfaction of the partial denture.
the patient satisfaction is measured by questionnaire.
measure: dimensional stability
time frame: 1 month
description: The first week at the time of insertion measuring the dimensional stability immediately after partial denture insertion.
The third week measuring the dimensional stability of the partial denture,The fourth week measuring the dimensional stability of the partial denture.
dimensional stability is measured by digital caliper.
arm group label: group 1
arm group type: Active Comparator
description: patients will receive partial denture constructed from breflex material.
arm group label: group 2
arm group type: Experimental
description: patients will receive partial denture constructed from PEEK material.
intervention type: Other
intervention name: PEEK
description: Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years but recently used as removable prosthetic material. Advantages of this polymer material are elimination of allergic reactions, high polishing qualities, low plaque affinity, and good wear resistance.
It has been proven that it shows high mechanical and biological properties. Studies evaluating the properties of this material are limited and need more clinical tests.
arm group label: group 2
intervention type: Other
intervention name: Bre.flex
description: Bre.flex is a nylon-based thermoplastic material, composed of nylon PA 12 (polyamide).Nylon exhibits high physical strength, heat resistance and chemical resistance. It can be easily modified to increase stiffness and wear resistance. Nylon resin can be semi-translucent and provides excellent esthetics but it is a little more difficult to adjust and polish.
arm group label: group 1
criteria: 
gender: All
minimum age: 45 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sylvia Sami Melek Ekladios
investigator title: principal investigator
sharing ipd: Undecided