<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/NCT03782714</url>
  </required_header>
  <id_info>
    <org_study_id>Alaa Nadhreen</org_study_id>
    <nct_id>NCT03782714</nct_id>
  </id_info>
  <brief_title>Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies</brief_title>
  <official_title>Clinical and Radiographic Evaluation of Low-level Laser Therapy in Human Primary Molar Pulpotomies: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to assess and compare the clinical and radiographic success rates of LLLT&#xD;
      and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36&#xD;
      children aging five to eight years were included and randomly assigned into two equal groups;&#xD;
      LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Various agents are available to dress the remaining pulp tissue after pulpotomy&#xD;
      procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays,&#xD;
      low-level laser therapy (LLLT) becomes a technique of interest, due to its many&#xD;
      characteristics. However, the literature available on its success in pulpotomy is limited and&#xD;
      reported conflicting results.&#xD;
&#xD;
      Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT&#xD;
      and FC for pulpotomy in human primary teeth.&#xD;
&#xD;
      Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary&#xD;
      molars from 36 children aging five to eight years. The teeth were selected based on specific&#xD;
      clinical and radiographic inclusion criteria and randomly assigned into two equal groups;&#xD;
      LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53&#xD;
      teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated&#xD;
      clinically and radiographically at 3, 6 and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>It is a split-mouth randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>3 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>6 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>12 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic success rate</measure>
    <time_frame>3 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:&#xD;
Normal periodontal ligament space&#xD;
No inter-radicular or periapical radiolucency&#xD;
No internal or external root resorption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic success rate</measure>
    <time_frame>6 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:&#xD;
Normal periodontal ligament space&#xD;
No inter-radicular or periapical radiolucency&#xD;
No internal or external root resorption</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiographic success rate</measure>
    <time_frame>12 months</time_frame>
    <description>The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:&#xD;
Normal periodontal ligament space&#xD;
No inter-radicular or periapical radiolucency&#xD;
No internal or external root resorption</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Pulpotomy</condition>
  <arm_group>
    <arm_group_label>Low-level laser therapy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group of teeth received laser irradiation after amputation of coronal pulp</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formocresol group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Low-level laser therapy</intervention_name>
    <description>It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing</description>
    <arm_group_label>Low-level laser therapy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children inclusion criteria:&#xD;
&#xD;
          -  Children aged 5-8 years with at least two bilateral deep carious primary molars&#xD;
             indicated for pulpotomy.&#xD;
&#xD;
          -  Children who are physically and mentally healthy without any known medical history of&#xD;
             systemic conditions contraindicating pulp therapy.&#xD;
&#xD;
          -  Children who had &quot;positive&quot; or &quot;definitely positive&quot; behavioral ratings according to&#xD;
             the Frankl behavior classification scale (Frankl, 1962).&#xD;
&#xD;
          -  Children whose parents signed an informed consent for the child's participation in the&#xD;
             study.&#xD;
&#xD;
        Teeth inclusion criteria:&#xD;
&#xD;
        Teeth were selected according to clinical and radiographic criteria.&#xD;
&#xD;
        Clinically, the study included:&#xD;
&#xD;
          -  Teeth with restorable crowns&#xD;
&#xD;
          -  Teeth with pathologic carious exposure of vital pulps&#xD;
&#xD;
          -  Teeth with no tenderness to percussion, physiologic or pathologic mobility or any&#xD;
             clinical evidence of pulp inflammation or degeneration such as history of swelling,&#xD;
             pain or presence of sinus tract.&#xD;
&#xD;
        Radiographically, the recruited teeth should have:&#xD;
&#xD;
          -  Normal radiographic appearance with healthy supporting tissues&#xD;
&#xD;
          -  No pulp calcification&#xD;
&#xD;
          -  No internal or external root resorption&#xD;
&#xD;
          -  No periapical or inter-radicular radiolucency&#xD;
&#xD;
          -  At least two thirds of the root remaining (not more than one third of the root is&#xD;
             physiologically resorbed)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any child complained of clinical signs such as pain, swelling, abnormal mobility,&#xD;
             vertical or lateral tenderness to percussion was excluded from the study.&#xD;
&#xD;
          -  Radiographically, any child with signs of internal or external root resorption or&#xD;
             periapical or inter-radicular pathology was omitted from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Abdulaziz University, Dental University Hospital</name>
      <address>
        <city>Jeddah</city>
        <zip>21589</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Najlaa Alamoudi</investigator_full_name>
    <investigator_title>Professor at the Pediatric Dentistry Department</investigator_title>
  </responsible_party>
  <keyword>Low-level laser therapy, pulpotomy, formocresol</keyword>
  <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/NCT03782714
org study id: Alaa Nadhreen
nct id: NCT03782714
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aimed to assess and compare the clinical and radiographic success rates of LLLT
      and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36
      children aging five to eight years were included and randomly assigned into two equal groups;
      LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12
      months.
Background: Various agents are available to dress the remaining pulp tissue after pulpotomy
      procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays,
      low-level laser therapy (LLLT) becomes a technique of interest, due to its many
      characteristics. However, the literature available on its success in pulpotomy is limited and
      reported conflicting results.

      Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT
      and FC for pulpotomy in human primary teeth.

      Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary
      molars from 36 children aging five to eight years. The teeth were selected based on specific
      clinical and radiographic inclusion criteria and randomly assigned into two equal groups;
      LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53
      teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated
      clinically and radiographically at 3, 6 and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It is a split-mouth randomized controlled clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical success rate
time frame: 3 months
description: The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
measure: Clinical success rate
time frame: 6 months
description: The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
measure: Clinical success rate
time frame: 12 months
description: The pulpotomy procedure was considered clinically successful if there were no pain, swelling, tenderness to percussion, abscess or abnormal mobility
measure: Radiographic success rate
time frame: 3 months
description: The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
Normal periodontal ligament space
No inter-radicular or periapical radiolucency
No internal or external root resorption
measure: Radiographic success rate
time frame: 6 months
description: The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
Normal periodontal ligament space
No inter-radicular or periapical radiolucency
No internal or external root resorption
measure: Radiographic success rate
time frame: 12 months
description: The pulpotomy procedure was considered clinically successful if it demonstrated the following criteria:
Normal periodontal ligament space
No inter-radicular or periapical radiolucency
No internal or external root resorption
arm group label: Low-level laser therapy group
arm group type: Experimental
description: This group of teeth received laser irradiation after amputation of coronal pulp
arm group label: Formocresol group
arm group type: No Intervention
description: This group of teeth received the gold standard medication (formocresol) after coronal pulp amputation
intervention type: Device
intervention name: Low-level laser therapy
description: It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing
arm group label: Low-level laser therapy group
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Najlaa Alamoudi
investigator title: Professor at the Pediatric Dentistry Department
sharing ipd: No