<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/NCT03810560</url>
  </required_header>
  <id_info>
    <org_study_id>PER16-30M</org_study_id>
    <nct_id>NCT03810560</nct_id>
  </id_info>
  <brief_title>Erbium Chromium: YSGG Laser Effect on Surgical Treatment of Chronic Periodontitis</brief_title>
  <official_title>Microbiological and Clinical Assessments of Erbium Chromium: YSGG Laser as an Adjunctive to Surgical Treatment of Chronic Periodontitis (Randomized Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>alaa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap&#xD;
      debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for&#xD;
      quantification of total bacterial load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups are randomly allocated (random number generation) by Microsoft excel into two&#xD;
      groups :&#xD;
&#xD;
        1. Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy&#xD;
           (Scaling &amp;Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket&#xD;
           therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.&#xD;
&#xD;
        2. Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy&#xD;
           (Scaling &amp;Curettage and root planing) will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Assessment of Plaque index(PI)</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene.&#xD;
recording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque&#xD;
plaque only detected by probe.&#xD;
Moderate deposits detected by naked eye.&#xD;
heavy deposits detected by naked eye.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analog Score for gingival inflammation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Probing depth (PD).</measure>
    <time_frame>6 months</time_frame>
    <description>measured by milli meters for detection of level of periodontal destruction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Clinical attachment level (CAL) .</measure>
    <time_frame>6 months</time_frame>
    <description>measured by milli meters for detection of level of periodontal destruction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Gingival recession(GR)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by milli meters for detection of level of apical migration of gingival attachment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Assessment of Modified sulcular bleeding index (MSBI)</measure>
    <time_frame>6 months</time_frame>
    <description>Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding.&#xD;
=pin pointed bleeding.&#xD;
= linear bleeding.&#xD;
= Heavy or profuse bleeding.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)</measure>
    <time_frame>3 months</time_frame>
    <description>quantification of total bacterial load</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Generalized Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>open flap debridement</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>surgical treatment of periodontal pocket without any intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>laser device with open flap debridement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>surgical intervention associated with application of Erbium chromium: YSGG laser therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser device Er,Cr:YSGG laser</intervention_name>
    <description>laser device with open flap debridement</description>
    <arm_group_label>laser device with open flap debridement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients are diagnosed to have chronic periodontitis, having infrabony posterior&#xD;
             periodontal pocket measuring 5 mm or more.&#xD;
&#xD;
          -  female or male.&#xD;
&#xD;
          -  25 - 55 years.&#xD;
&#xD;
          -  Medically controlled according to medical coding of review of systems .&#xD;
&#xD;
          -  Patient without history of drug administration in last month .&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Tobacco smoking.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients not follow periodontal hygienic instructions.&#xD;
&#xD;
          -  Patients under any medication that affect periodontal healing.&#xD;
&#xD;
          -  The presence of any systemic disease that affect periodontal healing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>March 4, 2023</last_update_submitted>
  <last_update_submitted_qc>March 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>alaa</investigator_full_name>
    <investigator_title>Teaching Assistant</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03810560
org study id: PER16-30M
nct id: NCT03810560
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Microbiological and Clinical assessment of Er,Cr:YSGG laser in conjunction to open flap
      debridement (OFD) in treatment of chronic periodontitis through real time PCR assay for
      quantification of total bacterial load.
Two groups are randomly allocated (random number generation) by Microsoft excel into two
      groups :

        1. Group (1) Open Flap debridement (OFD) surgery after conventional periodontal therapy
           (Scaling &Curettage and root planing) combined by Er,Cr:YSGG Laser assisted pocket
           therapy (ELAPT) which will be applied to pocket epithelial lining and root surface.

        2. Group (2) Open Flap debridement (OFD) surgery after conventional periodontal therapy
           (Scaling &Curettage and root planing) will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical Assessment of Plaque index(PI)
time frame: 6 months
description: Visual Analog Score for plaque for detection amount of plaque accumulation so assess patient oral hygiene.
recording is based on both soft and mineralized debris. Each surface will have a score from 0 to 3. 0: no plaque
plaque only detected by probe.
Moderate deposits detected by naked eye.
heavy deposits detected by naked eye.
measure: Clinical Assessment of Gingival index(GI) to assess gingival inflammation. 0: normal gingiva. 1: mild inflammation . 2: moderate inflammation . 3: sever inflammation marked redness and edema and spontaneous bleeding.
time frame: 6 months
description: Visual Analog Score for gingival inflammation
measure: Clinical Assessment of Probing depth (PD).
time frame: 6 months
description: measured by milli meters for detection of level of periodontal destruction.
measure: Clinical Assessment of Clinical attachment level (CAL) .
time frame: 6 months
description: measured by milli meters for detection of level of periodontal destruction.
measure: Clinical Assessment of Gingival recession(GR)
time frame: 6 months
description: measured by milli meters for detection of level of apical migration of gingival attachment.
measure: Clinical Assessment of Modified sulcular bleeding index (MSBI)
time frame: 6 months
description: Visual Analog Score of bleeding for detection of inflammatory status level. Modified Sulcus Bleeding Index(MSBI) 0 = No bleeding on bleeding.
=pin pointed bleeding.
= linear bleeding.
= Heavy or profuse bleeding.
measure: Microbiological assessment through real time PCR assay for quantification of total bacterial load by universal probe and primer set (16sr RNA)
time frame: 3 months
description: quantification of total bacterial load
arm group label: open flap debridement
arm group type: No Intervention
description: surgical treatment of periodontal pocket without any intervention
arm group label: laser device with open flap debridement
arm group type: Active Comparator
description: surgical intervention associated with application of Erbium chromium: YSGG laser therapy
intervention type: Device
intervention name: laser device Er,Cr:YSGG laser
description: laser device with open flap debridement
arm group label: laser device with open flap debridement
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: alaa
investigator title: Teaching Assistant
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No