xml: <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/NCT05983653</url>
    </required_header>
    <id_info>
      <org_study_id>arthrocentesis and PRP on TMJ</org_study_id>
      <nct_id>NCT05983653</nct_id>
    </id_info>
    <brief_title>Evaluation of Arthrocentesis With and Without PRP Injection in Patients With Disc Displacement With Reduction.</brief_title>
    <official_title>Evaluation of Arthrocentesis With and Without Platelet Rich Plasma Injection in Patients With Disc Displacement With Reduction.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cairo University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cairo University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is aiming to evaluate whether large volume of irrigation alone or combined with&#xD;
        PRP injection is sufficient for improvement of clinical signs and symptoms&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main aim is to determine whether large arthrocentesis volumes with and without PRP will&#xD;
        affect the treatment outcome of arthrocentesis , in relation to pain , mouth opening ,&#xD;
        improves jaw movement, disc position and patients satisfaction . PICO&#xD;
  &#xD;
        (P): population : patient with TMD and have clinical signs of disc displacement (I):&#xD;
        Intervention: arthrocentesis with normal saline (C): Comparison: two groups 200 ml of normal&#xD;
        saline lavage and 200 ml arthrocentesis with PRP (O):Outcome :&#xD;
  &#xD;
        Interventions: All patients involved in this study will be divided in to two different&#xD;
        groups, one group will receive arthrocentesis with PRP and other group received&#xD;
        arthrocentesis only&#xD;
  &#xD;
        A through medical and dental history followed by clinical examination was carried out for all&#xD;
        patients. Clinical measurements were taken to ensure patient adherence to our initial&#xD;
        inclusion criteria prior to further investigations. A preoperative digital panoramic&#xD;
        radiograph with 1:1 magnification was taken for each patient as a primary survey in order to&#xD;
        exclude the presence of any lesion at the area of interest and MRI to evaluate disc position&#xD;
  &#xD;
        Intra operative procedures for 2 groups:&#xD;
  &#xD;
        This clinical report describes 2 different manipulations of arthrocentesis with or without&#xD;
        PRP&#xD;
  &#xD;
        • In two group: infiltration of plain anesthesia was administered using mepivacaine HCl (3%)&#xD;
        to anaesthetizing the auriculotemporal nerve followed by posterior deep&#xD;
  &#xD;
        temporal and masseter nerves.. Injection to control pain . Scrubbing and draping of the&#xD;
        patient was carried out in a standard fashion using betadine surgical scrub.&#xD;
  &#xD;
        A straight line is drawn from the medial portion of the ear tragus to the lateral corner of&#xD;
        the eye. In this line, two needle insertion points are marked. The first, more posterior&#xD;
        point will be at a distance of 10 mm from the tragus and 2 mm below the canthus tragus line.&#xD;
        This is the approximate area of the maximum concavity of the glenoid fossa. The distance is&#xD;
        about 25mm from skin to the centre of the joint space .The second point will be 20 mm in&#xD;
        front of tragus and 10 mm below this same line.&#xD;
  &#xD;
        This marking indicates the site of the eminence of the TMJ. After the points of insertion for&#xD;
        the two needles have been marked, local anaesthetic is injected at the planned entrance&#xD;
        points. Two 19 gauge needles are inserted in the anterior and posterior recesses of the upper&#xD;
        joint space . Through one needle, normal saline 200 ml is injected into the superior joint&#xD;
        space. The second needle acts as an outflow portal, which allows lavage of the joint cavity&#xD;
  &#xD;
          -  in the control group:&#xD;
  &#xD;
          -  in the 1 st study group: The lavage will be 200 ml of normal saline&#xD;
  &#xD;
          -  in the 2 nd study group: The lavage will be 200 ml of normal saline +PRP&#xD;
  &#xD;
        Follow up Patients will be evaluated at day of arthrocentesis and weekly there after for the&#xD;
        first month and then after 6 month. clinical assessment will be achieved postoperatively to&#xD;
        calculate and assessment of mouth opening , pain and jaw movement.&#xD;
  &#xD;
        Recruitment:&#xD;
  &#xD;
          1. Patients' data will be enrolled in database of the Outpatient clinics of the Department&#xD;
             of Oral &amp; maxillofacial surgery, Faculty of Dentistry, Cairo University&#xD;
  &#xD;
          2. If there is a potential eligibility, the patient will be examined thoroughly as&#xD;
             described before.&#xD;
  &#xD;
          3. Consecutive sampling is done through screening of patients. This will continue until the&#xD;
             target population is achieved.&#xD;
  &#xD;
          4. Identifying and recruiting potential subjects is achieved through patient database&#xD;
             Assignment of interventions&#xD;
  &#xD;
        Allocation:&#xD;
  &#xD;
          1. Randomization:&#xD;
  &#xD;
             assistant supervisor will carry out the randomization process using a software&#xD;
             www.rand.org with a ratio of 1:1.&#xD;
  &#xD;
          2. Allocation concealment mechanism:&#xD;
  &#xD;
             All patients who give consent for participation and who fulfill the inclusion criteria&#xD;
             will be randomized. Funded patient files in a dark sealed envelope will be the method&#xD;
             for allocation concealment.&#xD;
  &#xD;
          3. Implementation The supervisors are responsible of division the sealed envelopes into&#xD;
             four groups and implementation for patients allocation. Enrolling and helping&#xD;
             participants to interventions will by researcher&#xD;
  &#xD;
             Masking/blinding:&#xD;
  &#xD;
             Each patient will be given a code by the researcher and the observers will be blind to&#xD;
             which group this case belong. Patients, evaluators and statistician will be blinded.&#xD;
  &#xD;
             Data collection, management, and analysis:&#xD;
  &#xD;
             Data collection methods Primary Outcome: The researcher and assistant supervisor. will&#xD;
             calculate and assessment of mouth opening , pain and jaw movement for TWO groups.&#xD;
  &#xD;
             Plans to promote participant retention and complete follow- up:&#xD;
  &#xD;
             Participant Retention:&#xD;
  &#xD;
             A periodic regular follow up recalls will be planned .&#xD;
  &#xD;
             Participant Withdrawal:&#xD;
  &#xD;
             The patient is allowed to drop at any time from the study Participant withdrawal will be&#xD;
             recorded and the patient will be excluded from the study. A percentage in the sample&#xD;
             size is calculated to make up for any losses. The investigator also may withdraw&#xD;
             participants from the study under strict certain conditions and only if the proposed&#xD;
             therapy were considered harmful to the patient.&#xD;
  &#xD;
             Data management:&#xD;
  &#xD;
             Data forms and data entry&#xD;
  &#xD;
             All these procedures will be done by Supervisor :&#xD;
  &#xD;
             All data will be entered electronically. Patient files are to be stored in numerical&#xD;
             order and stored in secure and accessible place. All data will be maintained in storage&#xD;
             for 1 year after completion of the study.&#xD;
  &#xD;
             The electronic data and the scans of the patient will be backed up on a Drop box file&#xD;
             for ensuring back up and ease of accessibility. Data Transmission and editing The&#xD;
             assessor data entry will be transmitted from the assessors to database officer in the&#xD;
             blind separate datasheets who in return record them in participant chart before sending&#xD;
             them to the statistician. Security and Back-up of data All forms of the procedures&#xD;
             related to study data will be kept in the project secure folder. Access to the study&#xD;
             data will be restricted only to database officer. A complete back up of the primary&#xD;
             database will be performed twice a month. Back-ups of periodic data analysis file will&#xD;
             be kept.&#xD;
  &#xD;
             Statistical methods:&#xD;
  &#xD;
             Data will be coded and entered using the statistical package SPSS version 22. Data will&#xD;
             be summarized using mean and standard deviation. Data will be explored for normality&#xD;
             using kolmogorov smirnov test. Comparisons between two groups for normally distributed&#xD;
             data will be done using analysis of variance (ANOVA), while for non-normally distributed&#xD;
             numeric variable will be done by kruskal wallis test. Categorical data will be analyzed&#xD;
             using chi square test. P value less than or equal to 0.05 will be considered&#xD;
             statistically significant. All test will be two tailed.&#xD;
  &#xD;
             Data monitoring:&#xD;
  &#xD;
             Monitoring The main supervisor will be responsible for data monitoring to evaluate the&#xD;
             outcome measures and any possible side effects that might affect the outcome.&#xD;
  &#xD;
             Audit Auditing of the study design will be done by the assistant supervisor&#xD;
  &#xD;
             Ethics and dissemination&#xD;
  &#xD;
             Research ethics approval This protocol and the template informed consent form will be&#xD;
             reviewed by the Ethics Committee of Scientific Research - Faculty of Dentistry - Cairo&#xD;
             University&#xD;
  &#xD;
             Protocol amendments Any modifications to the protocol which may impact on the conduct of&#xD;
             the study, potential benefit of the patient or may affect patient safety, including&#xD;
             changes of study objectives, study design, sample sizes, study procedures, or&#xD;
             significant administrative aspects will require a formal amendment to the protocol. Such&#xD;
             amendment will be agreed upon by the Council of oral and maxillofacial surgery&#xD;
             department.&#xD;
  &#xD;
             Informed consent Researcher M.A will introduce and discuss the trial to patients who&#xD;
             will be shown a video regarding the main aspects of the trial. Patients will then be&#xD;
             able to have an informed discussion with the participating consultant. Researcher will&#xD;
             obtain written consent from patients willing to participate in the trial. All consent&#xD;
             forms will be translated into Arabic.&#xD;
  &#xD;
             Confidentiality All study-related information such as photos, panoramic x-ray, forms,&#xD;
             charts will be stored in a password protected folder on the department database. The&#xD;
             password will be available to the study team. But any personal information related to&#xD;
             the patient's ID will be stored in and will acquire a coded ID with access only to the&#xD;
             database officer.&#xD;
  &#xD;
             Declaration of interest The study is self-funded and there is no conflict of interest to&#xD;
             declare.&#xD;
  &#xD;
             Access to data All the research team will have access to the data sets. All data sets&#xD;
             will be password protected. To ensure confidentiality, data dispersed to project team&#xD;
             members will be blinded of any identifying participant information and the participant&#xD;
             will be only identified by patient number.&#xD;
  &#xD;
             Post-trial care All patients will have the primary research contact number in case there&#xD;
             is any emergency. Follow up will continue until all patients are satisfied.&#xD;
  &#xD;
             Dissemination policy Study results will be published as partial fulfillment of the&#xD;
             requirements for master's degree in Oral and maxillofacial surgery. Topics suggested for&#xD;
             presentation or publication will be circulated to the authors&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</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>After medical and dental history then clinical examination. A preoperative panoramic radiograph was taken as a primary survey to exclude the presence of any lesion at the area of interest and MRI to evaluate disc position infiltration of plain anesthesia was administered to anaesthetizing the auriculotemporal ,posterior deep temporal and masseter nerves.Scrubbing and draping of the patient was carried out by using betadine.Drawn canthotragal line.two needle insertion points are marked. The first, will be at a distance of 10 mm from the tragus and 2 mm below the cantotragal line. The second point will be 20 mm in front of tragus and 10 mm below this same line. Two 19 gauge needles are inserted in this 2 points(upper joint space) .normal saline 200 ml is injected into the superior joint space. The second needle acts as an outflow portal&#xD;
  in the 1 st study group:The lavage will be 200 ml of normal saline&#xD;
  in the 2 nd study group:The lavage will be 200 ml of normal saline +PRP</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>TMJ pain</measure>
      <time_frame>first day , after 1 week , after 1 month and after 6 months of procedure</time_frame>
      <description>pain will be measured by Numerical rating scale from 0-10 (0 the lowest pain , 10 the greatest pain) ,will be measured before intervention , immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>mouth opening improves</measure>
      <time_frame>first day , after 1 week , after 1 month and after 6 months of procedure</time_frame>
      <description>mouth opening improves will be measured by ruler (millimeter) ,will be measured before inervention , immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention )</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Jaw movement</measure>
      <time_frame>first day , after 1 week , after 1 month and after 6 months of procedure</time_frame>
      <description>Jaw movements has long been used as a measure for clinical diagnosis and assessment quantifying the movements of opening/closing, protrusion and laterotrusion of the mandible , if there any deviation or any abnormality of movement ,will be assessment before intervention, immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Disc position on TMJ</measure>
      <time_frame>before procedure and after 6 months of procedure</time_frame>
      <description>Disc position will by Magnetic resonance imaging (MRI) assessment if their anterior disc displacement with reduction , before intervention and after 6 month of intervention for any improvement with disc position</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>after 6 months of intervention</time_frame>
      <description>Patient satisfaction will be assessment by Numerical rating scale from 1-10 ( 1 the best, 10 the worst)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>TMJ Disc Disorder</condition>
    <arm_group>
      <arm_group_label>200 ml of normal saline lavage</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>in the first arm will be used 200 ml of normal saline lavage alone without PRP</description>
    </arm_group>
    <arm_group>
      <arm_group_label>200 ml arthrocentesis with PRP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>in the second arm will be used 200 ml of normal saline arthrocentesis with PRP</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>arthrocentesis without PRP</intervention_name>
      <description>200 ml arthrocentesis without PRP</description>
      <arm_group_label>200 ml of normal saline lavage</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>arthrocentesis with PRP</intervention_name>
      <description>200 ml arthrocentesis with PRP</description>
      <arm_group_label>200 ml arthrocentesis with PRP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Chronic pain with good range of motion and anterior disk displacement with reduction&#xD;
  &#xD;
            -  Degenerative osteoarthritis&#xD;
  &#xD;
            -  patients with painful joint noises occurring during mouth opening and/or closing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  psychiatric&#xD;
  &#xD;
            -  pathology, fibrous and osseous ankylosis&#xD;
  &#xD;
            -  multiply operated joints&#xD;
  &#xD;
            -  regional infectious disease and tumors of the joint&#xD;
  &#xD;
            -  Immunosuppressed or immunocompromised&#xD;
  &#xD;
            -  Patients participating in other studies, if the present protocol could not be properly&#xD;
               followed.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yasmine AA Nassar</last_name>
      <role>Study Director</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mohammad IM Alhoor, BSc</last_name>
      <phone>01014253972</phone>
      <phone_ext>+2</phone_ext>
      <email>mohammad.alhoor@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Enas FM Eldaour, BSc</last_name>
      <phone>0101667613</phone>
      <phone_ext>+2</phone_ext>
      <email>enas.fadel@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Faculty of dentistry Cairo Universty</name>
        <address>
          <city>Cairo</city>
          <state>Manial</state>
          <zip>11511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Faculty OD Universty</last_name>
        <phone>0223634965</phone>
        <phone_ext>+2</phone_ext>
        <email>dentmail@dentistry.cu.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <reference>
      <citation>Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.</citation>
      <PMID>36523721</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Mohammad Ibraheem Mahmoud Alhoor</investigator_full_name>
      <investigator_title>Principal Investigator ,master degree candidiate</investigator_title>
    </responsible_party>
    <keyword>anterior disc displacment with reduction</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05983653
  org study id: arthrocentesis and PRP on TMJ
  nct id: NCT05983653
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is aiming to evaluate whether large volume of irrigation alone or combined with
        PRP injection is sufficient for improvement of clinical signs and symptoms
  The main aim is to determine whether large arthrocentesis volumes with and without PRP will
        affect the treatment outcome of arthrocentesis , in relation to pain , mouth opening ,
        improves jaw movement, disc position and patients satisfaction . PICO
  
        (P): population : patient with TMD and have clinical signs of disc displacement (I):
        Intervention: arthrocentesis with normal saline (C): Comparison: two groups 200 ml of normal
        saline lavage and 200 ml arthrocentesis with PRP (O):Outcome :
  
        Interventions: All patients involved in this study will be divided in to two different
        groups, one group will receive arthrocentesis with PRP and other group received
        arthrocentesis only
  
        A through medical and dental history followed by clinical examination was carried out for all
        patients. Clinical measurements were taken to ensure patient adherence to our initial
        inclusion criteria prior to further investigations. A preoperative digital panoramic
        radiograph with 1:1 magnification was taken for each patient as a primary survey in order to
        exclude the presence of any lesion at the area of interest and MRI to evaluate disc position
  
        Intra operative procedures for 2 groups:
  
        This clinical report describes 2 different manipulations of arthrocentesis with or without
        PRP
  
        • In two group: infiltration of plain anesthesia was administered using mepivacaine HCl (3%)
        to anaesthetizing the auriculotemporal nerve followed by posterior deep
  
        temporal and masseter nerves.. Injection to control pain . Scrubbing and draping of the
        patient was carried out in a standard fashion using betadine surgical scrub.
  
        A straight line is drawn from the medial portion of the ear tragus to the lateral corner of
        the eye. In this line, two needle insertion points are marked. The first, more posterior
        point will be at a distance of 10 mm from the tragus and 2 mm below the canthus tragus line.
        This is the approximate area of the maximum concavity of the glenoid fossa. The distance is
        about 25mm from skin to the centre of the joint space .The second point will be 20 mm in
        front of tragus and 10 mm below this same line.
  
        This marking indicates the site of the eminence of the TMJ. After the points of insertion for
        the two needles have been marked, local anaesthetic is injected at the planned entrance
        points. Two 19 gauge needles are inserted in the anterior and posterior recesses of the upper
        joint space . Through one needle, normal saline 200 ml is injected into the superior joint
        space. The second needle acts as an outflow portal, which allows lavage of the joint cavity
  
          -  in the control group:
  
          -  in the 1 st study group: The lavage will be 200 ml of normal saline
  
          -  in the 2 nd study group: The lavage will be 200 ml of normal saline +PRP
  
        Follow up Patients will be evaluated at day of arthrocentesis and weekly there after for the
        first month and then after 6 month. clinical assessment will be achieved postoperatively to
        calculate and assessment of mouth opening , pain and jaw movement.
  
        Recruitment:
  
          1. Patients' data will be enrolled in database of the Outpatient clinics of the Department
             of Oral & maxillofacial surgery, Faculty of Dentistry, Cairo University
  
          2. If there is a potential eligibility, the patient will be examined thoroughly as
             described before.
  
          3. Consecutive sampling is done through screening of patients. This will continue until the
             target population is achieved.
  
          4. Identifying and recruiting potential subjects is achieved through patient database
             Assignment of interventions
  
        Allocation:
  
          1. Randomization:
  
             assistant supervisor will carry out the randomization process using a software
             www.rand.org with a ratio of 1:1.
  
          2. Allocation concealment mechanism:
  
             All patients who give consent for participation and who fulfill the inclusion criteria
             will be randomized. Funded patient files in a dark sealed envelope will be the method
             for allocation concealment.
  
          3. Implementation The supervisors are responsible of division the sealed envelopes into
             four groups and implementation for patients allocation. Enrolling and helping
             participants to interventions will by researcher
  
             Masking/blinding:
  
             Each patient will be given a code by the researcher and the observers will be blind to
             which group this case belong. Patients, evaluators and statistician will be blinded.
  
             Data collection, management, and analysis:
  
             Data collection methods Primary Outcome: The researcher and assistant supervisor. will
             calculate and assessment of mouth opening , pain and jaw movement for TWO groups.
  
             Plans to promote participant retention and complete follow- up:
  
             Participant Retention:
  
             A periodic regular follow up recalls will be planned .
  
             Participant Withdrawal:
  
             The patient is allowed to drop at any time from the study Participant withdrawal will be
             recorded and the patient will be excluded from the study. A percentage in the sample
             size is calculated to make up for any losses. The investigator also may withdraw
             participants from the study under strict certain conditions and only if the proposed
             therapy were considered harmful to the patient.
  
             Data management:
  
             Data forms and data entry
  
             All these procedures will be done by Supervisor :
  
             All data will be entered electronically. Patient files are to be stored in numerical
             order and stored in secure and accessible place. All data will be maintained in storage
             for 1 year after completion of the study.
  
             The electronic data and the scans of the patient will be backed up on a Drop box file
             for ensuring back up and ease of accessibility. Data Transmission and editing The
             assessor data entry will be transmitted from the assessors to database officer in the
             blind separate datasheets who in return record them in participant chart before sending
             them to the statistician. Security and Back-up of data All forms of the procedures
             related to study data will be kept in the project secure folder. Access to the study
             data will be restricted only to database officer. A complete back up of the primary
             database will be performed twice a month. Back-ups of periodic data analysis file will
             be kept.
  
             Statistical methods:
  
             Data will be coded and entered using the statistical package SPSS version 22. Data will
             be summarized using mean and standard deviation. Data will be explored for normality
             using kolmogorov smirnov test. Comparisons between two groups for normally distributed
             data will be done using analysis of variance (ANOVA), while for non-normally distributed
             numeric variable will be done by kruskal wallis test. Categorical data will be analyzed
             using chi square test. P value less than or equal to 0.05 will be considered
             statistically significant. All test will be two tailed.
  
             Data monitoring:
  
             Monitoring The main supervisor will be responsible for data monitoring to evaluate the
             outcome measures and any possible side effects that might affect the outcome.
  
             Audit Auditing of the study design will be done by the assistant supervisor
  
             Ethics and dissemination
  
             Research ethics approval This protocol and the template informed consent form will be
             reviewed by the Ethics Committee of Scientific Research - Faculty of Dentistry - Cairo
             University
  
             Protocol amendments Any modifications to the protocol which may impact on the conduct of
             the study, potential benefit of the patient or may affect patient safety, including
             changes of study objectives, study design, sample sizes, study procedures, or
             significant administrative aspects will require a formal amendment to the protocol. Such
             amendment will be agreed upon by the Council of oral and maxillofacial surgery
             department.
  
             Informed consent Researcher M.A will introduce and discuss the trial to patients who
             will be shown a video regarding the main aspects of the trial. Patients will then be
             able to have an informed discussion with the participating consultant. Researcher will
             obtain written consent from patients willing to participate in the trial. All consent
             forms will be translated into Arabic.
  
             Confidentiality All study-related information such as photos, panoramic x-ray, forms,
             charts will be stored in a password protected folder on the department database. The
             password will be available to the study team. But any personal information related to
             the patient's ID will be stored in and will acquire a coded ID with access only to the
             database officer.
  
             Declaration of interest The study is self-funded and there is no conflict of interest to
             declare.
  
             Access to data All the research team will have access to the data sets. All data sets
             will be password protected. To ensure confidentiality, data dispersed to project team
             members will be blinded of any identifying participant information and the participant
             will be only identified by patient number.
  
             Post-trial care All patients will have the primary research contact number in case there
             is any emergency. Follow up will continue until all patients are satisfied.
  
             Dissemination policy Study results will be published as partial fulfillment of the
             requirements for master's degree in Oral and maxillofacial surgery. Topics suggested for
             presentation or publication will be circulated to the authors
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: After medical and dental history then clinical examination. A preoperative panoramic radiograph was taken as a primary survey to exclude the presence of any lesion at the area of interest and MRI to evaluate disc position infiltration of plain anesthesia was administered to anaesthetizing the auriculotemporal ,posterior deep temporal and masseter nerves.Scrubbing and draping of the patient was carried out by using betadine.Drawn canthotragal line.two needle insertion points are marked. The first, will be at a distance of 10 mm from the tragus and 2 mm below the cantotragal line. The second point will be 20 mm in front of tragus and 10 mm below this same line. Two 19 gauge needles are inserted in this 2 points(upper joint space) .normal saline 200 ml is injected into the superior joint space. The second needle acts as an outflow portal
  in the 1 st study group:The lavage will be 200 ml of normal saline
  in the 2 nd study group:The lavage will be 200 ml of normal saline +PRP
  primary purpose: Treatment
  masking: None (Open Label)
  measure: TMJ pain
  time frame: first day , after 1 week , after 1 month and after 6 months of procedure
  description: pain will be measured by Numerical rating scale from 0-10 (0 the lowest pain , 10 the greatest pain) ,will be measured before intervention , immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention )
  measure: mouth opening improves
  time frame: first day , after 1 week , after 1 month and after 6 months of procedure
  description: mouth opening improves will be measured by ruler (millimeter) ,will be measured before inervention , immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention )
  measure: Jaw movement
  time frame: first day , after 1 week , after 1 month and after 6 months of procedure
  description: Jaw movements has long been used as a measure for clinical diagnosis and assessment quantifying the movements of opening/closing, protrusion and laterotrusion of the mandible , if there any deviation or any abnormality of movement ,will be assessment before intervention, immediately after intervention and on follow up ( 1 week , 1 month , 6 month after intervention)
  measure: Disc position on TMJ
  time frame: before procedure and after 6 months of procedure
  description: Disc position will by Magnetic resonance imaging (MRI) assessment if their anterior disc displacement with reduction , before intervention and after 6 month of intervention for any improvement with disc position
  measure: Patient satisfaction
  time frame: after 6 months of intervention
  description: Patient satisfaction will be assessment by Numerical rating scale from 1-10 ( 1 the best, 10 the worst)
  arm group label: 200 ml of normal saline lavage
  arm group type: Active Comparator
  description: in the first arm will be used 200 ml of normal saline lavage alone without PRP
  arm group label: 200 ml arthrocentesis with PRP
  arm group type: Active Comparator
  description: in the second arm will be used 200 ml of normal saline arthrocentesis with PRP
  intervention type: Procedure
  intervention name: arthrocentesis without PRP
  description: 200 ml arthrocentesis without PRP
  arm group label: 200 ml of normal saline lavage
  intervention type: Procedure
  intervention name: arthrocentesis with PRP
  description: 200 ml arthrocentesis with PRP
  arm group label: 200 ml arthrocentesis with PRP
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yasmine AA Nassar
  role: Study Director
  affiliation: Cairo University
  last name: Mohammad IM Alhoor, BSc
  phone: 01014253972
  phone ext: +2
  email: mohammad.alhoor@dentistry.cu.edu.eg
  last name: Enas FM Eldaour, BSc
  phone: 0101667613
  phone ext: +2
  email: enas.fadel@dentistry.cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  citation: Abbadi W, Kara Beit Z, Al-Khanati NM. Arthrocentesis, Injectable Platelet-Rich Plasma and Combination of Both Protocols of Temporomandibular Joint Disorders Management: A Single-Blinded Randomized Clinical Trial. Cureus. 2022 Nov 11;14(11):e31396. doi: 10.7759/cureus.31396. eCollection 2022 Nov.
  PMID: 36523721
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Mohammad Ibraheem Mahmoud Alhoor
  investigator title: Principal Investigator ,master degree candidiate