<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/NCT03769402</url>
  </required_header>
  <id_info>
    <org_study_id>52-376</org_study_id>
    <nct_id>NCT03769402</nct_id>
  </id_info>
  <brief_title>The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile</brief_title>
  <official_title>The Influence of Citric Acid Bone Surface Etching and Bone Substitute Intra-osseous Defect Fill on Crevicular Fluid BMP-2 Release Profile (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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of citric acid on bone surface of infrabony defects when used&#xD;
      for 30 seconds at ph 1 and 50% concentration before the application of bovine derived&#xD;
      xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5&#xD;
      different days during the first month after surgery and clinical and radiographic parameters&#xD;
      were reassessed after 6 months&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Citric acid have been widely used to treat root surfaces of periodontally affected teeth in&#xD;
      order to render it biologically suitable for fibroblast reattachment. however, systematic&#xD;
      reviews showed no clinical significance when it was used as a root surface conditioner.&#xD;
      Recently it was found in experimental studies that when citric acid was used on bone surface&#xD;
      for a brief period, it increased bone formation and improved consolidation of grafted bone to&#xD;
      bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50%&#xD;
      concentration for 30 seconds before washing it off and then application of bovine derived&#xD;
      xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by&#xD;
      taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and&#xD;
      radiographic parameters were taken after 6 months of follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</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</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone Morphogenic protein 2</measure>
    <time_frame>1 day</time_frame>
    <description>The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Morphogenic protein 2</measure>
    <time_frame>3 days</time_frame>
    <description>The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Morphogenic protein 2</measure>
    <time_frame>7 days</time_frame>
    <description>The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Morphogenic protein 2</measure>
    <time_frame>14 days</time_frame>
    <description>The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bone Morphogenic protein 2</measure>
    <time_frame>30 days</time_frame>
    <description>The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival Index</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation of the amount of dental plaque according to Silness &amp; Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic bone fill</measure>
    <time_frame>6 months</time_frame>
    <description>Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Intrabony Periodontal Defect</condition>
  <arm_group>
    <arm_group_label>Citric acid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Citric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control test</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Citric acid</intervention_name>
    <description>Citric acid ph1, 50% concentration solution</description>
    <arm_group_label>Citric acid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Test</intervention_name>
    <description>Control group, xenograft was used to fill infrabony defects without treating bone surface</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders aged between 32-60 years.&#xD;
&#xD;
          -  Selected patient with a single site of:&#xD;
&#xD;
               1. Two walled or three walled infra-bony defect.&#xD;
&#xD;
               2. The bone defect should be at least 3 mm in depth from the crest of the alveolar&#xD;
                  bone to the base of the defect.&#xD;
&#xD;
               3. Pocket depth of more than or equal to 5 mm.&#xD;
&#xD;
               4. Clinical attachment loss equal or more than 3mm&#xD;
&#xD;
          -  Patients ready to comply with oral hygiene measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic disease that contra-indicates periodontal surgery or may affect healing.&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Drug abusers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Moustafa Mukhtar</investigator_full_name>
    <investigator_title>Teaching assistant</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>December 14, 2018</submitted>
    <submission_canceled>December 19, 2018</submission_canceled>
    <submitted>December 19, 2018</submitted>
    <returned>January 9, 2019</returned>
  </pending_results>
  <!-- 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/NCT03769402
org study id: 52-376
nct id: NCT03769402
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study evaluates the effect of citric acid on bone surface of infrabony defects when used
      for 30 seconds at ph 1 and 50% concentration before the application of bovine derived
      xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5
      different days during the first month after surgery and clinical and radiographic parameters
      were reassessed after 6 months
Citric acid have been widely used to treat root surfaces of periodontally affected teeth in
      order to render it biologically suitable for fibroblast reattachment. however, systematic
      reviews showed no clinical significance when it was used as a root surface conditioner.
      Recently it was found in experimental studies that when citric acid was used on bone surface
      for a brief period, it increased bone formation and improved consolidation of grafted bone to
      bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50%
      concentration for 30 seconds before washing it off and then application of bovine derived
      xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by
      taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and
      radiographic parameters were taken after 6 months of follow-up
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trial
primary purpose: Treatment
masking: Single (Participant)
measure: Bone Morphogenic protein 2
time frame: 1 day
description: The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
measure: Bone Morphogenic protein 2
time frame: 3 days
description: The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
measure: Bone Morphogenic protein 2
time frame: 7 days
description: The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
measure: Bone Morphogenic protein 2
time frame: 14 days
description: The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
measure: Bone Morphogenic protein 2
time frame: 30 days
description: The level of Bone morphogenic protein 2 was measured in the gingival crevicular fluid using a perio-paper then the marker level was determined using an Enzyme linked immunosorbent kit (ELISA kit)
measure: Gingival Index
time frame: 6 months
description: Estimation of the degree of gingival inflammation was done according to Loe where scores were given between 0-3 (0=no inflammation and 3=severe inflammation)
measure: Plaque index
time frame: 6 months
description: Estimation of the amount of dental plaque according to Silness & Loe where scores were given between 0-3 (0=no plaque and 3=presence of abundant plaque)
measure: Probing depth
time frame: 6 months
description: Estimation was done by measuring the depth from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe
measure: Clinical attachment level
time frame: 6 months
description: Estimation was done by measuring the distance from the cemento-enamel junction to the base of the pocket using a UNC-15 periodontal probe
measure: Radiographic bone fill
time frame: 6 months
description: Estimation was done by taking a linear measurement using RVG system from the baseline defect till the alveolar bone crest
arm group label: Citric acid
arm group type: Active Comparator
description: Citric acid PH1 and concentration 50% was used for 30 seconds on bone surface before washing it off and filling the defect with xenograft
arm group label: Control
arm group type: Placebo Comparator
description: Control test
intervention type: Drug
intervention name: Citric acid
description: Citric acid ph1, 50% concentration solution
arm group label: Citric acid
intervention type: Drug
intervention name: Control Test
description: Control group, xenograft was used to fill infrabony defects without treating bone surface
arm group label: Control
other name: Control
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Moustafa Mukhtar
investigator title: Teaching assistant
mesh term: Citric Acid
mesh term: Sodium Citrate
submitted: December 14, 2018
submission canceled: December 19, 2018
submitted: December 19, 2018
returned: January 9, 2019