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/NCT05984173</url>
    </required_header>
    <id_info>
      <org_study_id>7132023asu</org_study_id>
      <nct_id>NCT05984173</nct_id>
    </id_info>
    <brief_title>Role of Vitamin E in Reducing Dry Socket</brief_title>
    <official_title>the Role of Vitamin E in Reducing Incidence of Dry Socket in Female Patients. A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams 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>
        90 female patients seeking extraction of a single tooth in the lower posterior region were&#xD;
        divided randomly into 45 patients received vitamin E inside the socket after extraction&#xD;
        (study group) and 45 patients didn't receive vitamin E after extraction (control group).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        I. Patient Selection and Grouping:&#xD;
  &#xD;
        This study was conducted on a total number of 90 female patients seeking extraction of a&#xD;
        single tooth in the lower posterior region, selected from those attending the outpatient&#xD;
        clinic of the oral and maxillofacial surgery department in the faculty of dentistry, Ain&#xD;
        Shams University and Misr University for Science &amp; Technology, Egypt as divided randomly into&#xD;
        45 patients received vitamin E inside the socket after extraction (study group) and 45&#xD;
        patients didn't receive vitamin E after extraction (control group).&#xD;
  &#xD;
        II. Sample Size Calculation:&#xD;
  &#xD;
        In the prior assessment of the article by Haraji et al. (Effects of Intra-alveolar Placement&#xD;
        of 0.2% Chlorhexidine Bioadhesive Gel on Dry Socket Incidence and Postsurgical Pain: A&#xD;
        Double-Blind Split-Mouth Randomized Controlled Clinical Trial) and setting alpha at 0.05 and&#xD;
        Beta at 0.8 the data showed that the minimum number of patients to be included in each group&#xD;
        was 18.&#xD;
  &#xD;
        III. Blinding\Masking:&#xD;
  &#xD;
        Blinding of biostatistician was achieved while blinding of participants and operator wasn't&#xD;
        possible as the operator is the outcome assessor.&#xD;
  &#xD;
        IV. Research Ethics Approval:&#xD;
  &#xD;
        The research was reviewed by the Research Ethics Committee (REC) of the Faculty of Dentistry,&#xD;
        Ain Shams University.&#xD;
  &#xD;
        V. Preoperative Assessment:&#xD;
  &#xD;
          1. Patient Evaluation:&#xD;
  &#xD;
             Each female has been evaluated for the following:&#xD;
  &#xD;
             A. Medical History:&#xD;
  &#xD;
             Full medical history was taken to exclude any patient according to the exclusion&#xD;
             criteria.&#xD;
  &#xD;
             B. Dental History:&#xD;
  &#xD;
             Full dental history was taken including the history of previous incidences of dry&#xD;
             socket.&#xD;
  &#xD;
             C. Chief Complaint All patients were asked about the current dental chief complaint to&#xD;
             exclude any patient who needed dental treatment other than extraction.&#xD;
  &#xD;
          2. Clinical Examination:&#xD;
  &#xD;
             A. Extra-Oral Examination:&#xD;
  &#xD;
             All patients were examined by the operator including facial appearance and facial bone.&#xD;
  &#xD;
             B. Intra-Oral Examination:&#xD;
  &#xD;
             This examination included:&#xD;
  &#xD;
               -  General examination of oral health, checking the teeth adjacent to the extracted&#xD;
                  tooth and oral hard and soft tissues.&#xD;
  &#xD;
               -  Examination of extracted tooth including tenderness and mobility tests.&#xD;
  &#xD;
          3. Radiographic Assessment Radiographic assessment was done using a periapical radiograph&#xD;
             to examine the surrounding bone, exclude any pathological lesion, and detect the&#xD;
             location of the inferior alveolar canal, especially during extraction of lower third&#xD;
             molars.&#xD;
  &#xD;
          4. Photography:&#xD;
  &#xD;
             Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1)&#xD;
  &#xD;
          5. Surgical Preparation:&#xD;
  &#xD;
        A. Anesthetic Protocol:&#xD;
  &#xD;
        The extraction procedures were done under local anesthesia using 4% articaine solution with&#xD;
        adrenaline 1:100,000, as 1.2 ml for Inferior Alveolar Nerve block (IANB), 0.3 ml for lingual&#xD;
        nerve block and 0.3 ml for long buccal nerve block on the side of the extraction.&#xD;
  &#xD;
        B. Preparation of Gel Foam and Vitamin E:&#xD;
  &#xD;
        A piece of gel foam was cut into 1 X1 cm2.&#xD;
  &#xD;
        C. Extraction Procedure:&#xD;
  &#xD;
          -  All extractions were performed by the same surgeon using standard English-Style Vertical&#xD;
             Hinge forceps in a standardized buccolingual technique for socket expansion.&#xD;
  &#xD;
          -  The extraction procedures were done simply using forceps or elevators without raising&#xD;
             mucoperiosteal flaps or anything that make the procedure surgical. Figure (2)&#xD;
  &#xD;
        D. Packing of the Gel Foam:&#xD;
  &#xD;
        The prepared gel foam was packed inside the socket to be covering the walls of the socket and&#xD;
        not be oversized.&#xD;
  &#xD;
        E. Suture with Figure 8:&#xD;
  &#xD;
        A horizontal Figure 8 suture was applied for stabilization. Figure (3)&#xD;
  &#xD;
        F. Post-Operative Instructions:&#xD;
  &#xD;
          -  Keep biting on the gauze for 1 hour.&#xD;
  &#xD;
          -  Avoid eating or drinking hot stuff on the first post-extraction day.&#xD;
  &#xD;
          -  Soft and cold food can be consumed after 2 hours on the other side.&#xD;
  &#xD;
          -  Avoid rinsing for the next 24 hours after extraction.&#xD;
  &#xD;
          -  Rinsing the mouth with warm saline 3 times daily on the 2nd day and continued for 5&#xD;
             days.&#xD;
  &#xD;
          -  Avoid smoking.&#xD;
  &#xD;
          -  Rest and avoid strenuous activities for the remainder of the day.&#xD;
  &#xD;
          -  Patients were given a prescription for Diclofenac Potassium to be used twice daily for&#xD;
             three days.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2022</start_date>
    <completion_date type="Actual">December 10, 2022</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>Phase 4</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>Randomized clinical trial two groups</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Double blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Decrease of incidence of dry socket and pain</measure>
      <time_frame>one week</time_frame>
      <description>Evaluation of patient satisfaction and pain was done and recorded according to VAS which is a scale from 1-10. patient mention degree of pain on this scale</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Dry Socket</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>patients received vitamin E inside the socket after extraction (study group)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>patients didn't receive vitamin E after extraction (control group).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vitamin E application</intervention_name>
      <description>patients received vitamin E inside the socket after extraction</description>
      <arm_group_label>study group</arm_group_label>
      <other_name>tocopherol</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients 30-50 years of age.&#xD;
  &#xD;
            -  Patients with single tooth in the lower posterior region need simple extraction.&#xD;
  &#xD;
            -  Compliance with all requirements in the study and signing the informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with any medical condition that may influence the outcome (uncontrolled&#xD;
               diabetes, Hyperparathyroidism, Hyperthyroidism, Cushing's disease, Paget's disease,&#xD;
               Glucocorticoids).&#xD;
  &#xD;
            -  Vulnerable groups (children, pregnant women, elderly people, malnourished people,&#xD;
               prisoners, migrants, and refugees).&#xD;
  &#xD;
            -  Patients with systemic disease affecting bone healing (osteoporosis, Rickets, and&#xD;
               osteomalacia).&#xD;
  &#xD;
            -  Chronic Patients on medications known to affect the periodontal status (calcium&#xD;
               antagonists, anticonvulsive, immunosuppressive, anti-inflammatory medications).&#xD;
  &#xD;
            -  Patients with a history of bisphosphonate use.&#xD;
  &#xD;
            -  Pathologic lesions in the site of extraction.&#xD;
  &#xD;
            -  Lactating mothers.&#xD;
  &#xD;
            -  Smoking patients.&#xD;
  &#xD;
            -  Patients currently on radiotherapy and or chemotherapy treatment.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>only biological female because estrogen is limiting factor</gender_description>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>mohamed diaa</last_name>
      <role>Study Director</role>
      <affiliation>Ain shams</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Ain shams University</name>
        <address>
          <city>Cairo</city>
          <zip>11757</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.</citation>
      <PMID>12190139</PMID>
    </results_reference>
    <verification_date>January 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dry socket</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dry Socket</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vitamin E</mesh_term>
      <mesh_term>Tocopherols</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Not planning to share</ipd_description>
    </patient_data>
    <!-- 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/NCT05984173
  org study id: 7132023asu
  nct id: NCT05984173
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  90 female patients seeking extraction of a single tooth in the lower posterior region were
        divided randomly into 45 patients received vitamin E inside the socket after extraction
        (study group) and 45 patients didn't receive vitamin E after extraction (control group).
  I. Patient Selection and Grouping:
  
        This study was conducted on a total number of 90 female patients seeking extraction of a
        single tooth in the lower posterior region, selected from those attending the outpatient
        clinic of the oral and maxillofacial surgery department in the faculty of dentistry, Ain
        Shams University and Misr University for Science & Technology, Egypt as divided randomly into
        45 patients received vitamin E inside the socket after extraction (study group) and 45
        patients didn't receive vitamin E after extraction (control group).
  
        II. Sample Size Calculation:
  
        In the prior assessment of the article by Haraji et al. (Effects of Intra-alveolar Placement
        of 0.2% Chlorhexidine Bioadhesive Gel on Dry Socket Incidence and Postsurgical Pain: A
        Double-Blind Split-Mouth Randomized Controlled Clinical Trial) and setting alpha at 0.05 and
        Beta at 0.8 the data showed that the minimum number of patients to be included in each group
        was 18.
  
        III. Blinding\Masking:
  
        Blinding of biostatistician was achieved while blinding of participants and operator wasn't
        possible as the operator is the outcome assessor.
  
        IV. Research Ethics Approval:
  
        The research was reviewed by the Research Ethics Committee (REC) of the Faculty of Dentistry,
        Ain Shams University.
  
        V. Preoperative Assessment:
  
          1. Patient Evaluation:
  
             Each female has been evaluated for the following:
  
             A. Medical History:
  
             Full medical history was taken to exclude any patient according to the exclusion
             criteria.
  
             B. Dental History:
  
             Full dental history was taken including the history of previous incidences of dry
             socket.
  
             C. Chief Complaint All patients were asked about the current dental chief complaint to
             exclude any patient who needed dental treatment other than extraction.
  
          2. Clinical Examination:
  
             A. Extra-Oral Examination:
  
             All patients were examined by the operator including facial appearance and facial bone.
  
             B. Intra-Oral Examination:
  
             This examination included:
  
               -  General examination of oral health, checking the teeth adjacent to the extracted
                  tooth and oral hard and soft tissues.
  
               -  Examination of extracted tooth including tenderness and mobility tests.
  
          3. Radiographic Assessment Radiographic assessment was done using a periapical radiograph
             to examine the surrounding bone, exclude any pathological lesion, and detect the
             location of the inferior alveolar canal, especially during extraction of lower third
             molars.
  
          4. Photography:
  
             Intra-oral Photographs were taken before establishing the surgical procedure. Figure (1)
  
          5. Surgical Preparation:
  
        A. Anesthetic Protocol:
  
        The extraction procedures were done under local anesthesia using 4% articaine solution with
        adrenaline 1:100,000, as 1.2 ml for Inferior Alveolar Nerve block (IANB), 0.3 ml for lingual
        nerve block and 0.3 ml for long buccal nerve block on the side of the extraction.
  
        B. Preparation of Gel Foam and Vitamin E:
  
        A piece of gel foam was cut into 1 X1 cm2.
  
        C. Extraction Procedure:
  
          -  All extractions were performed by the same surgeon using standard English-Style Vertical
             Hinge forceps in a standardized buccolingual technique for socket expansion.
  
          -  The extraction procedures were done simply using forceps or elevators without raising
             mucoperiosteal flaps or anything that make the procedure surgical. Figure (2)
  
        D. Packing of the Gel Foam:
  
        The prepared gel foam was packed inside the socket to be covering the walls of the socket and
        not be oversized.
  
        E. Suture with Figure 8:
  
        A horizontal Figure 8 suture was applied for stabilization. Figure (3)
  
        F. Post-Operative Instructions:
  
          -  Keep biting on the gauze for 1 hour.
  
          -  Avoid eating or drinking hot stuff on the first post-extraction day.
  
          -  Soft and cold food can be consumed after 2 hours on the other side.
  
          -  Avoid rinsing for the next 24 hours after extraction.
  
          -  Rinsing the mouth with warm saline 3 times daily on the 2nd day and continued for 5
             days.
  
          -  Avoid smoking.
  
          -  Rest and avoid strenuous activities for the remainder of the day.
  
          -  Patients were given a prescription for Diclofenac Potassium to be used twice daily for
             three days.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized clinical trial two groups
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Double blinded
  measure: Decrease of incidence of dry socket and pain
  time frame: one week
  description: Evaluation of patient satisfaction and pain was done and recorded according to VAS which is a scale from 1-10. patient mention degree of pain on this scale
  arm group label: study group
  arm group type: Experimental
  description: patients received vitamin E inside the socket after extraction (study group)
  arm group label: control
  arm group type: No Intervention
  description: patients didn't receive vitamin E after extraction (control group).
  intervention type: Drug
  intervention name: Vitamin E application
  description: patients received vitamin E inside the socket after extraction
  arm group label: study group
  other name: tocopherol
  criteria: 
  gender: Female
  gender based: Yes
  gender description: only biological female because estrogen is limiting factor
  minimum age: 30 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: mohamed diaa
  role: Study Director
  affiliation: Ain shams
  facility: 
  country: Egypt
  citation: Blum IR. Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of standardization, aetiopathogenesis and management: a critical review. Int J Oral Maxillofac Surg. 2002 Jun;31(3):309-17. doi: 10.1054/ijom.2002.0263.
  PMID: 12190139
  responsible party type: Sponsor
  mesh term: Dry Socket
  mesh term: Vitamin E
  mesh term: Tocopherols
  sharing ipd: No
  ipd description: Not planning to share