<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/NCT03025568</url>
  </required_header>
  <id_info>
    <org_study_id>1989</org_study_id>
    <nct_id>NCT03025568</nct_id>
  </id_info>
  <brief_title>Retention of Peek and Bre.Flex Materials Maxillary Bilateral Bounded Removable Partial Dentures</brief_title>
  <official_title>Comparative Study of Retention of Peek and Bre.Flex Materials Maxillary Bilateral 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 of the retention of upper removable partial denture constructed from two different&#xD;
      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.&#xD;
&#xD;
      Final impression will be taken by elastomeric impression material. The impression will be&#xD;
      poured into type IV dental stone in order to obtain master cast. The master cast will be&#xD;
      surveyed. The proposed design will be as follows: metal framework base saddle for edentulous&#xD;
      areas on both sides connected with palatal strap. Aker's clasp on all abutments with buccal&#xD;
      retention. The denture base will be tried in with acrylic teeth in patient's mouth. After&#xD;
      that, the denture base of the partial denture will be processed incorporation with the metal&#xD;
      framework into the two different materials to be evaluated. The first group will receive the&#xD;
      partial denture in which the metal framework incorporated with the denture base fabricated&#xD;
      from PEEK material. The second group will receive the partial denture in which the metal&#xD;
      framework 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>March 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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of Retention of removable partial denture constructed from PEEK and Bre-flex</measure>
    <time_frame>One month</time_frame>
    <description>The first week, at the time of insertion measuring Retention immediately after partial denture insertion,The third week measuring Retention of the partial denture, The fourth week measuring Retention of the partial denture.&#xD;
retention is measured by digital force gauge device.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">17</enrollment>
  <condition>Retention</condition>
  <arm_group>
    <arm_group_label>group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patient will receive partial denture constructed from Bre_flex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive removable partial denture constructed from PEEK</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEEK</intervention_name>
    <description>PEEK (poly-ether-ether-ketone) has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high biocompatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth. Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.</description>
    <arm_group_label>group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bre.flex</intervention_name>
    <description>In the recent time thermoplastic materials (breflex) become quite popular in clinical practice such as nylon and acetal resins. since the 1950, polyamide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus.</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>January 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>January 17, 2017</last_update_submitted>
  <last_update_submitted_qc>January 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Doaa Mohamed Sayed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>nylon</keyword>
  <keyword>polyamide</keyword>
  <keyword>denture base</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/NCT03025568
org study id: 1989
nct id: NCT03025568
lead sponsor: 
has dmc: Yes
Evaluation of the retention 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
masking: Triple (Participant, Care Provider, Investigator)
measure: Evaluation of Retention of removable partial denture constructed from PEEK and Bre-flex
time frame: One month
description: The first week, at the time of insertion measuring Retention immediately after partial denture insertion,The third week measuring Retention of the partial denture, The fourth week measuring Retention of the partial denture.
retention is measured by digital force gauge device.
arm group label: group 1
arm group type: Active Comparator
description: Patient will receive partial denture constructed from Bre_flex
arm group label: group 2
arm group type: Experimental
description: Patients will receive removable partial denture constructed from PEEK
intervention type: Other
intervention name: PEEK
description: PEEK (poly-ether-ether-ketone) has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high biocompatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth. Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.
arm group label: group 2
intervention type: Other
intervention name: Bre.flex
description: In the recent time thermoplastic materials (breflex) become quite popular in clinical practice such as nylon and acetal resins. since the 1950, polyamide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus.
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: Doaa Mohamed Sayed
investigator title: principal investigator
sharing ipd: Undecided