<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/NCT03038737</url>
  </required_header>
  <id_info>
    <org_study_id>1234</org_study_id>
    <nct_id>NCT03038737</nct_id>
  </id_info>
  <brief_title>Comparative Study of Biting Force of Injection Molded PEEK and Bre.Flex for Removable Partial Dentures.</brief_title>
  <official_title>Comparative Study Of Biting Force 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to evaluate the biting force of upper removable partial&#xD;
      denture constructed from two different flexible thermoplastic materials.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient will be treated in visits designated as follows:&#xD;
&#xD;
      Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical&#xD;
      x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their&#xD;
      alveolar bone support of abutment) and primary impression will be performed with irreversible&#xD;
      hydro-colloid impression material (alginate), The impressions will be poured with type IV&#xD;
      dental stone to obtain diagnostic casts .&#xD;
&#xD;
      Visit 2: Maxillary Face-bow will be recorded. The diagnostic casts will be mounted on semi&#xD;
      adjustable articulator in centric occluding relation to evaluate the interarch distance and&#xD;
      occlusal plane.&#xD;
&#xD;
      Visit 3: primary surveying is performed. Special trays will be constructed and Mouth&#xD;
      preparation will be performed by preparing guiding planes and rests seats will be prepared&#xD;
      opposing to the edentulous area. Final impression will be taken by elastomeric impression&#xD;
      material. The impression will be poured into type IV dental stone in order to obtain master&#xD;
      cast. The master cast will be surveyed. The proposed design will be as follows: metal&#xD;
      framework base saddle for edentulous areas on both sides connected with palatal strap. Aker's&#xD;
      clasp on all abutments with buccal retention.&#xD;
&#xD;
      Visit 4: the metal framework is tried into the patient's mouth. Jaw relation is recorded.&#xD;
&#xD;
      Visit 5: The denture base will be tried in with acrylic teeth in patient's mouth.&#xD;
&#xD;
      Visit 6: the denture base of the partial denture will be processed incorporation with the&#xD;
      metal framework into the two different materials to be evaluated. The first group will&#xD;
      receive the partial denture in which the metal framework incorporated with the denture base&#xD;
      fabricated from PEEK material. The second group will receive the partial denture in which the&#xD;
      metal framework incorporated with the denture base material fabricated from BRE-FLEX.&#xD;
&#xD;
      Visit7,8,9: clinical measurement will be performed for one month in three visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">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>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Biting force</measure>
    <time_frame>1 month</time_frame>
    <description>the change in biting force will be recorded three times. The first week at the time of insertion measuring the biting force immediately after partial denture insertion. The third week measuring biting force of the partial denture. The fourth week measuring biting force of the partial denture.&#xD;
the biting force will be measured by I-load sensor.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Biting</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>bre.flex</intervention_name>
    <description>In the recent time thermoplastic materials 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(3).&#xD;
The major disadvantage of a nylon RDP is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality.</description>
    <arm_group_label>group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PEEK</intervention_name>
    <description>PEEK 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>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  i. All patients must have Kennedy class III modification I upper partially edentulous&#xD;
             ridges.&#xD;
&#xD;
        ii. The remaining teeth have good periodontal condition, with no signs of attrition or&#xD;
        gingival recession.&#xD;
&#xD;
        iii. Male or female patient with age range (45-55) and in good medical condition iv. All&#xD;
        patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient&#xD;
        interarch distance.&#xD;
&#xD;
        v. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of&#xD;
        masticatory muscles.&#xD;
&#xD;
        vi. Free from any tempro-mandibular joint disorder. vii. The patients have good oral&#xD;
        hygiene and low caries index.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  i. Patients having abnormal habits as bruxism or clenching ii. Patients having&#xD;
             hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not&#xD;
             included.&#xD;
&#xD;
        iii. Teeth with compromised bone support. iv. Patient with xerostomia or excessive&#xD;
        salivation. v. 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 26, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Arwa Mabrouk Ayad Issa</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/NCT03038737
org study id: 1234
nct id: NCT03038737
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the present study is to evaluate the biting force of upper removable partial
      denture constructed from two different flexible thermoplastic materials.
The patient will be treated in visits designated as follows:

      Visit 1: Preoperative records, clinical, radiographic examination (panoramic and periapical
      x-rays for evaluation the crown-root ratio, the apical condition of the abutment and their
      alveolar bone support of abutment) and primary 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 .

      Visit 2: 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.

      Visit 3: primary surveying is performed. 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.

      Visit 4: the metal framework is tried into the patient's mouth. Jaw relation is recorded.

      Visit 5: The denture base will be tried in with acrylic teeth in patient's mouth.

      Visit 6: 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.

      Visit7,8,9: clinical measurement will be performed for one month in three visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: change in Biting force
time frame: 1 month
description: the change in biting force will be recorded three times. The first week at the time of insertion measuring the biting force immediately after partial denture insertion. The third week measuring biting force of the partial denture. The fourth week measuring biting force of the partial denture.
the biting force will be measured by I-load sensor.
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: bre.flex
description: In the recent time thermoplastic materials 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(3).
The major disadvantage of a nylon RDP is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality.
arm group label: group 1
intervention type: Other
intervention name: PEEK
description: PEEK 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
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: Arwa Mabrouk Ayad Issa
investigator title: principal investigator
sharing ipd: Undecided