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/NCT06041178</url>
    </required_header>
    <id_info>
      <org_study_id>2022-H-0100-D-R-0487</org_study_id>
      <nct_id>NCT06041178</nct_id>
    </id_info>
    <brief_title>Flurbiprofen Versus Aloe Vera Gel in the Treatment of Chronic Periodontitis in Smoking Patients.</brief_title>
    <official_title>Efficiency of Flurbiprofen 2.5% in Comparison to 98% Aloe Vera Gel as an Adjunctive Therapy to Scaling and Root Planning in the Initial Treatment of Stage III Chronic Periodontitis in Smoking Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beirut Arab University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beirut Arab University</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aims to evaluate clinically the efficacy of flurbiprofen gel in comparison to Aloe&#xD;
        Vera gel as adjunctive to SRP in the reduction of periodontal pockets in patients with&#xD;
        chronic periodontitis in smoking patients.&#xD;
  &#xD;
        All patients will receive SRP prior to treatment.&#xD;
  &#xD;
          -  Group 1: one site will receive flurbiprofen while the contralateral site will receive a&#xD;
             placebo&#xD;
  &#xD;
          -  Group 2: one site will receive aloe vera while the contralateral site will receive a&#xD;
             placebo&#xD;
  &#xD;
          -  Group 3: one site will receive flurbiprofen while the contralateral site will receive&#xD;
             aloe vera Researchers will compare the inter and intra-groups differences to check if&#xD;
             there's a variation in the periodontal parameters measured.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Complete medical and dental histories as well as informed consent will be collected from&#xD;
        eligible participants, and periodontal charting will be done for them.&#xD;
  &#xD;
        Medical history and laboratory screening for all patients will be carried out at baseline.&#xD;
        All participants will undergo scaling and root planning. The selected patients will be&#xD;
        allocated into three groups with the help of a computerized randomizer (Randomizer.org) and&#xD;
        sites will be assigned as control or test based on a coin flip method:&#xD;
  &#xD;
          -  Group 1 (G1): 20 patients who received treatment involving the application of&#xD;
             flurbiprofen gel as an adjunct to scaling and root planing. Specifically, on the test&#xD;
             site of each patient, one milliliter of 2.5% flurbiprofen gel was applied, while on the&#xD;
             contralateral side, placebo gel was administered as the control intervention.&#xD;
  &#xD;
          -  Group 2 (G2): 20 patients who received treatment involving the application of aloe Vera&#xD;
             gel as an adjunct to scaling and root planing. Specifically, on the test site of each&#xD;
             patient, one milliliter of 98% aloe Vera was applied, while on the contralateral side,&#xD;
             placebo gel was administered as the control intervention.&#xD;
  &#xD;
          -  Group 3 (G3): The intervention involved applying flurbiprofen gel on one site, while the&#xD;
             contralateral side received an application of 98% aloe vera.&#xD;
  &#xD;
        The clinical examiner will not be informed of the treatment groups' distribution.&#xD;
  &#xD;
        Patients will be informed on self-performed plaque control measures. In the 4th week, 8th&#xD;
        week, 12th week, 6 months week clinical examination will be performed to measure the&#xD;
        periodontal pocket depth, gingival index, plaque index, clinical attachment level (CAL),and&#xD;
        bleeding on probing.&#xD;
  &#xD;
        Statistical analysis was done using SAS 9.4 Software (SAS Institute Inc., Cary, NC, USA).&#xD;
        Means and standard deviations (SD) were calculated for all continuous variables (periodontal&#xD;
        parameters: CAL, PD, BOP, GI, PI) at the baseline, fourth week, eighth week, and twelfth week&#xD;
        and 6 months. Repeated linear mixed-effects models (PROC MIXED in SAS) were used to examine&#xD;
        the changes in all periodontal parameters over the five-time points within each group and&#xD;
        between groups. An unstructured covariance matrix was used, residual plots were visually&#xD;
        reviewed to check model fit, and extreme outliers were eliminated using the restricted&#xD;
        likelihood distance. A Tukey-Kramer 8 correction was applied to all pairwise comparisons.&#xD;
        One-way ANOVA was used to examine group differences in PD reduction and CAL. A p-value of&#xD;
        0.05 was considered statistically significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 30, 2022</start_date>
    <completion_date type="Actual">July 19, 2023</completion_date>
    <primary_completion_date type="Actual">May 25, 2023</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>Factorial Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical attachment level</measure>
      <time_frame>6 months</time_frame>
      <description>used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Probing Depth</measure>
      <time_frame>6 months</time_frame>
      <description>used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bleeding on Probing</measure>
      <time_frame>6 months</time_frame>
      <description>It is an indicator of periodontal tissue inflammatory response. The probe is carefully introduced to the bottom of the pocket and gently moved laterally along the pocket wall. Depending on the severity of inflammation, bleeding can vary from a tenuous red line along the gingival sulcus to profuse bleeding (immediately after probing or few seconds after).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque index</measure>
      <time_frame>6 months</time_frame>
      <description>used to evaluate the level and rate of plaque formation on tooth surfaces. It measures the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The amount of plaque is determined with disclosing solution and a range of scores of 0-5 is assigned with 0 denoting no plaque and 5 denoting heavy plaque (covering 2/3 of the tooth crown)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival index</measure>
      <time_frame>6 months</time_frame>
      <description>used to assess the severity of gingival inflammation. Scores ranges from 0-3 with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. This measurement is based on the presence or absence of bleeding on gentle probing</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Periodontitis Chronic Generalized Severe</condition>
    <arm_group>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site</description>
    </arm_group>
    <arm_group>
      <arm_group_label>scaling and root planing + 98% aloe vera on one site and placebo on contralateral site</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site</description>
    </arm_group>
    <arm_group>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>2.5% flurbiprofen</intervention_name>
      <description>Gel was made of 20% poloxamer and 10% ethanol as an Optimum formulation with sustained release up to 48 hours and a reasonable sol gel transition phase (adjunctive to SRP)</description>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site</arm_group_label>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>98% aloe vera</intervention_name>
      <description>the Aloe vera gel employed possessed a concentration of 98% and was obtained from the reputable brand Avivir (Denmark). The remaining 2% comprised normal saline. The process of obtaining the 98% Aloe vera gel involved meticulous washing of mature Aloe Vera leaves under running water, followed by the removal of their outer skin. Subsequently, each leaf was divided into smaller pieces, from which the gel was allowed to seep out and carefully collected in a sterile container. The collected gel was then stored at 4°C until the time of its application in the study (adjunctive to SRP)</description>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site</arm_group_label>
      <arm_group_label>scaling and root planing + 98% aloe vera on one site and placebo on contralateral site</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>saline</description>
      <arm_group_label>scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site</arm_group_label>
      <arm_group_label>scaling and root planing + 98% aloe vera on one site and placebo on contralateral site</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria: 60 patients were selected who had clinical periodontal loss and&#xD;
          radiographic bone loss of stage III/grade C with no history of systemic disease. They had&#xD;
          at least 2 periodontal sites with a pocket depth of six mm or greater, radiographic&#xD;
          evidence of bone loss extending to the middle third of the root, and clinical attachment&#xD;
          loss of five mm or more. Eligible subjects were categorized as current smokers if they&#xD;
          consistently smoked more than 10 cigarettes per day for a minimum of 5 years. Additionally,&#xD;
          individuals with no record of undergoing any periodontal treatment within the six months&#xD;
          preceding the study were considered for inclusion.&#xD;
  &#xD;
          Exclusion criteria: Patients with systemic illnesses such as diabetes mellitus or&#xD;
          conditions that could potentially impair wound healing were excluded from participation.&#xD;
          Additionally, individuals who were pregnant or lactating were not considered for inclusion&#xD;
          in the study. Subjects who had been prescribed systemic antibiotics or non-steroidal&#xD;
          anti-inflammatory drugs (NSAIDs) within the three months preceding the study were also&#xD;
          excluded. Furthermore, individuals with confirmed or suspected hypersensitivity to&#xD;
          Flurbiprofen or aloe Vera, the focus of the investigation, were not included in the study&#xD;
          population.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nayer Aboelsaad, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Professor and Chairman of Periodontology department - BeirutArabU</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Beirut Arab University</name>
        <address>
          <city>Beirut</city>
          <country>Lebanon</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Lebanon</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Chronic Periodontitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Flurbiprofen</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>September 30, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT06041178/Prot_SAP_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>September 30, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT06041178/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06041178
  org study id: 2022-H-0100-D-R-0487
  nct id: NCT06041178
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to evaluate clinically the efficacy of flurbiprofen gel in comparison to Aloe
        Vera gel as adjunctive to SRP in the reduction of periodontal pockets in patients with
        chronic periodontitis in smoking patients.
  
        All patients will receive SRP prior to treatment.
  
          -  Group 1: one site will receive flurbiprofen while the contralateral site will receive a
             placebo
  
          -  Group 2: one site will receive aloe vera while the contralateral site will receive a
             placebo
  
          -  Group 3: one site will receive flurbiprofen while the contralateral site will receive
             aloe vera Researchers will compare the inter and intra-groups differences to check if
             there's a variation in the periodontal parameters measured.
  Complete medical and dental histories as well as informed consent will be collected from
        eligible participants, and periodontal charting will be done for them.
  
        Medical history and laboratory screening for all patients will be carried out at baseline.
        All participants will undergo scaling and root planning. The selected patients will be
        allocated into three groups with the help of a computerized randomizer (Randomizer.org) and
        sites will be assigned as control or test based on a coin flip method:
  
          -  Group 1 (G1): 20 patients who received treatment involving the application of
             flurbiprofen gel as an adjunct to scaling and root planing. Specifically, on the test
             site of each patient, one milliliter of 2.5% flurbiprofen gel was applied, while on the
             contralateral side, placebo gel was administered as the control intervention.
  
          -  Group 2 (G2): 20 patients who received treatment involving the application of aloe Vera
             gel as an adjunct to scaling and root planing. Specifically, on the test site of each
             patient, one milliliter of 98% aloe Vera was applied, while on the contralateral side,
             placebo gel was administered as the control intervention.
  
          -  Group 3 (G3): The intervention involved applying flurbiprofen gel on one site, while the
             contralateral side received an application of 98% aloe vera.
  
        The clinical examiner will not be informed of the treatment groups' distribution.
  
        Patients will be informed on self-performed plaque control measures. In the 4th week, 8th
        week, 12th week, 6 months week clinical examination will be performed to measure the
        periodontal pocket depth, gingival index, plaque index, clinical attachment level (CAL),and
        bleeding on probing.
  
        Statistical analysis was done using SAS 9.4 Software (SAS Institute Inc., Cary, NC, USA).
        Means and standard deviations (SD) were calculated for all continuous variables (periodontal
        parameters: CAL, PD, BOP, GI, PI) at the baseline, fourth week, eighth week, and twelfth week
        and 6 months. Repeated linear mixed-effects models (PROC MIXED in SAS) were used to examine
        the changes in all periodontal parameters over the five-time points within each group and
        between groups. An unstructured covariance matrix was used, residual plots were visually
        reviewed to check model fit, and extreme outliers were eliminated using the restricted
        likelihood distance. A Tukey-Kramer 8 correction was applied to all pairwise comparisons.
        One-way ANOVA was used to examine group differences in PD reduction and CAL. A p-value of
        0.05 was considered statistically significant.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: clinical attachment level
  time frame: 6 months
  description: used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket
  measure: Probing Depth
  time frame: 6 months
  description: used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.
  measure: Bleeding on Probing
  time frame: 6 months
  description: It is an indicator of periodontal tissue inflammatory response. The probe is carefully introduced to the bottom of the pocket and gently moved laterally along the pocket wall. Depending on the severity of inflammation, bleeding can vary from a tenuous red line along the gingival sulcus to profuse bleeding (immediately after probing or few seconds after).
  measure: Plaque index
  time frame: 6 months
  description: used to evaluate the level and rate of plaque formation on tooth surfaces. It measures the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The amount of plaque is determined with disclosing solution and a range of scores of 0-5 is assigned with 0 denoting no plaque and 5 denoting heavy plaque (covering 2/3 of the tooth crown)
  measure: Gingival index
  time frame: 6 months
  description: used to assess the severity of gingival inflammation. Scores ranges from 0-3 with 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling, and spontaneous bleeding. This measurement is based on the presence or absence of bleeding on gentle probing
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site
  arm group type: Experimental
  description: Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
  arm group label: scaling and root planing + 98% aloe vera on one site and placebo on contralateral site
  arm group type: Experimental
  description: Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site
  arm group type: Experimental
  description: Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site
  intervention type: Drug
  intervention name: 2.5% flurbiprofen
  description: Gel was made of 20% poloxamer and 10% ethanol as an Optimum formulation with sustained release up to 48 hours and a reasonable sol gel transition phase (adjunctive to SRP)
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site
  intervention type: Drug
  intervention name: 98% aloe vera
  description: the Aloe vera gel employed possessed a concentration of 98% and was obtained from the reputable brand Avivir (Denmark). The remaining 2% comprised normal saline. The process of obtaining the 98% Aloe vera gel involved meticulous washing of mature Aloe Vera leaves under running water, followed by the removal of their outer skin. Subsequently, each leaf was divided into smaller pieces, from which the gel was allowed to seep out and carefully collected in a sterile container. The collected gel was then stored at 4°C until the time of its application in the study (adjunctive to SRP)
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site
  arm group label: scaling and root planing + 98% aloe vera on one site and placebo on contralateral site
  intervention type: Other
  intervention name: Placebo
  description: saline
  arm group label: scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site
  arm group label: scaling and root planing + 98% aloe vera on one site and placebo on contralateral site
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Nayer Aboelsaad, PhD
  role: Study Chair
  affiliation: Professor and Chairman of Periodontology department - BeirutArabU
  facility: 
  country: Lebanon
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  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Chronic Periodontitis
  mesh term: Flurbiprofen
  sharing ipd: No
  provided document: 
  provided document: 