<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/NCT03765151</url>
  </required_header>
  <id_info>
    <org_study_id>HKUCTR-2390</org_study_id>
    <nct_id>NCT03765151</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Low-level Laser Therapy in Orthodontic Retention for Periodontal-compromised Patients</brief_title>
  <official_title>The Effectiveness of Low-level Laser Therapy as an Adjunct Strategy in Orthodontic Retention for Periodontal-compromised Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</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>
      The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients&#xD;
      with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects&#xD;
      will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects&#xD;
      on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of&#xD;
      life. The study design is a randomised controlled trail. To eliminate any bias, the&#xD;
      investigator will initially hypothesis there is no significant difference in the&#xD;
      aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those&#xD;
      retained in a conventional regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study design is a randomised split-mouth design based on the result of investigator's&#xD;
      pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65&#xD;
      years) with chronic periodontitis will be recruited. The teeth in experimental group will&#xD;
      receive LLLT during orthodontic retention period for 12 months, while the teeth in the&#xD;
      control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be&#xD;
      measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on&#xD;
      periodontal inflammation status will be evaluated by assessing clinical periodontal&#xD;
      parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on&#xD;
      bone remodelling will be explored by testing the biochemical biomarkers in gingival&#xD;
      crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical&#xD;
      evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's&#xD;
      quality of life will be investigated via validated questionnaires, subjective assessment of&#xD;
      tooth sensitivity, and objective measurement of bite force.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in probing pocket depth (PPD)</measure>
    <time_frame>debond, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in bleeding on probing (BOP)</measure>
    <time_frame>debond, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in clinical attachment loss (CAL)</measure>
    <time_frame>debond, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in plaque index (PI)</measure>
    <time_frame>debond, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Orthodontic outcome stability</measure>
    <time_frame>debond, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Assess the changes in Little's irregularity index (LII) in maxillar and mandibular anterior teeth in millimeters by measuring both plaster models and e-models</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar bone remodelling</measure>
    <time_frame>debond, 12 month follow-up</time_frame>
    <description>Alveolar bone remodelling will be assessed by the changes in height (measured in millimeters) and thickness (measured in millimeters) of alveolar marginal bone surrounding predetermined target teeth according to Cone Beam computed tomography.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supragingival and subgingival plaque</measure>
    <time_frame>debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Bacteria loads in supragingival and subgingival plaques will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical dentin sensitivity</measure>
    <time_frame>debond, each week interval during the first months, 3 months, 6 months and 12 months</time_frame>
    <description>Cervical dentin hypersensitivity will be evaluated by subjective assessment on a visual analogue scale (range from 0 to 100 mm) after a standardized stimuli applied on the test and control teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum voluntary bite force</measure>
    <time_frame>debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up</time_frame>
    <description>Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Orthodontics</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>LLLT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low-level laser therapy and orthodontic retention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>orthodontic retention and no laser treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>low-level laser therapy</intervention_name>
    <description>LLLT will be performed by a diode gallium-aluminum-arsenide (Ga-Al-As) laser with a 940-nm wavelength (Ezlase; Biolase Technology Inc., Irvine, CA) and delivered by a quadrant-sized probe which cover the region from the central incisor to the first molar on the test side. The laser probe will be 1 cm from the soft tissue around the test tooth at the gingival margin and alveolar mucosa covering the root area using a setting of 800 milliwatt in a continuous wave. Each tooth will receive 30 seconds of exposure, with no more than 8.6 J/cm2 of energy delivered. In addition, a spot-size laser probe will be applied for 30 seconds 5 mm from the cervical dentin with an output power of 700 milliwatt to reduce tooth sensitivity.</description>
    <arm_group_label>LLLT group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>orthodontic retention</intervention_name>
    <description>All participants included will wear fixed lingual retainer and removable retainers in the post-orthodontic retention period and their previous orthodontic treatment will be carried out by one operator using preadjusted appliances with bonded 0.022×0.028-inch2 brackets/buccal tubes and 0.014-inch Nickel Titanium (NiTi) archwires as the first archwires.</description>
    <arm_group_label>LLLT group</arm_group_label>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Thirty-five non-smoking Ethnic Chinese patients (male or female; age: 25-65 years) will be&#xD;
        recruited from the Prince Philip Dental Hospital, Faculty of Dentistry, the University of&#xD;
        Hong Kong into the following selection criteria:&#xD;
&#xD;
          1. Systemically health (with special regard to disease affecting tissue repair);&#xD;
&#xD;
          2. No medications required for periodontal therapy and no use of any antibiotic and/or&#xD;
             anti-inflammatory medication in the preceding month;&#xD;
&#xD;
          3. Chronic periodontitis with at least two pairs (clinically matched) displaced&#xD;
             single-rooted teeth (each pair of teeth is in the same arch but in two contralateral&#xD;
             hemi-arches respectively belonging to the same tooth typology) having at least one&#xD;
             site probing depth of 5 mm or more, interproximal attachment loss of 3 mm or more, and&#xD;
             radiographic signs of alveolar bone loss before periodontal and orthodontic treatment.&#xD;
&#xD;
          4. Recent completion of orthodontic treatment and readiness for debonding and retainer&#xD;
             delivery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. smoking;&#xD;
&#xD;
          2. pregnancy;&#xD;
&#xD;
          3. under orthodontic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanqi Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Prince Philip Dental Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Prince Philip Dental Hospital</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>low-level laser therapy</keyword>
  <keyword>orthodontic retention</keyword>
  <keyword>periodontal disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03765151
org study id: HKUCTR-2390
nct id: NCT03765151
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the effects of low-level laser therapy (LLLT) on patients
      with chronic periodontitis during a post-orthodontic period for 12 months. Following aspects
      will be assessed: 1. Effects on tooth stability maintenance and bone remodeling. 2. Effects
      on periodontal inflammation status. 3. Effects on cervical dentin sensitivity and quality of
      life. The study design is a randomised controlled trail. To eliminate any bias, the
      investigator will initially hypothesis there is no significant difference in the
      aforementioned aspects between teeth retained with an adjunctive LLLT strategy and those
      retained in a conventional regimen.
The study design is a randomised split-mouth design based on the result of investigator's
      pilot study. Thirty-five non-smoking Ethnic Chinese patients (male and female, age: 25-65
      years) with chronic periodontitis will be recruited. The teeth in experimental group will
      receive LLLT during orthodontic retention period for 12 months, while the teeth in the
      control (placebo) group will not receive laser therapy. Orthodontic occlusal indices will be
      measured to explore LLLT's role in maintaining tooth stability. The effects of LLLT on
      periodontal inflammation status will be evaluated by assessing clinical periodontal
      parameters and the levels of supra-gingival and sub-gingival bacteria. The effects of LLLT on
      bone remodelling will be explored by testing the biochemical biomarkers in gingival
      crevicular fluid (GCF). Cone-beam computed tomography will also be used to provide clinical
      evidence of periodontal status and bone remodelling. Possible effects of LLLT on patient's
      quality of life will be investigated via validated questionnaires, subjective assessment of
      tooth sensitivity, and objective measurement of bite force.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes in probing pocket depth (PPD)
time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Record the changes of probing pocket depth in millimeters from baseline to 3 months, 6 months and 12 months through probing.
measure: Changes in bleeding on probing (BOP)
time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Record the bleeding on probing changes from baseline to 3 months, 6 months and 12 months through probing.
measure: Changes in clinical attachment loss (CAL)
time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Record the clinical attachment loss (CAL) changes from baseline to to 3 months, 6 months and 12 months.
measure: Changes in plaque index (PI)
time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Record the plaque index (PI) changes from baseline to to 3 months, 6 months and 12 months.
measure: Orthodontic outcome stability
time frame: debond, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Assess the changes in Little's irregularity index (LII) in maxillar and mandibular anterior teeth in millimeters by measuring both plaster models and e-models
measure: Alveolar bone remodelling
time frame: debond, 12 month follow-up
description: Alveolar bone remodelling will be assessed by the changes in height (measured in millimeters) and thickness (measured in millimeters) of alveolar marginal bone surrounding predetermined target teeth according to Cone Beam computed tomography.
measure: Supragingival and subgingival plaque
time frame: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Bacteria loads in supragingival and subgingival plaques will be recorded.
measure: Cervical dentin sensitivity
time frame: debond, each week interval during the first months, 3 months, 6 months and 12 months
description: Cervical dentin hypersensitivity will be evaluated by subjective assessment on a visual analogue scale (range from 0 to 100 mm) after a standardized stimuli applied on the test and control teeth.
measure: Maximum voluntary bite force
time frame: debond, 1 month follow-up, 3 month follow-up, 6 month follow-up and 12 month follow-up
description: Use an standardized occlusal force gauge to record the magnitude of bite force in newton (N).
arm group label: LLLT group
arm group type: Experimental
description: Low-level laser therapy and orthodontic retention
arm group label: control group
arm group type: Placebo Comparator
description: orthodontic retention and no laser treatment.
intervention type: Device
intervention name: low-level laser therapy
description: LLLT will be performed by a diode gallium-aluminum-arsenide (Ga-Al-As) laser with a 940-nm wavelength (Ezlase; Biolase Technology Inc., Irvine, CA) and delivered by a quadrant-sized probe which cover the region from the central incisor to the first molar on the test side. The laser probe will be 1 cm from the soft tissue around the test tooth at the gingival margin and alveolar mucosa covering the root area using a setting of 800 milliwatt in a continuous wave. Each tooth will receive 30 seconds of exposure, with no more than 8.6 J/cm2 of energy delivered. In addition, a spot-size laser probe will be applied for 30 seconds 5 mm from the cervical dentin with an output power of 700 milliwatt to reduce tooth sensitivity.
arm group label: LLLT group
intervention type: Other
intervention name: orthodontic retention
description: All participants included will wear fixed lingual retainer and removable retainers in the post-orthodontic retention period and their previous orthodontic treatment will be carried out by one operator using preadjusted appliances with bonded 0.022×0.028-inch2 brackets/buccal tubes and 0.014-inch Nickel Titanium (NiTi) archwires as the first archwires.
arm group label: LLLT group
arm group label: control group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanqi Yang
role: Principal Investigator
affiliation: The Prince Philip Dental Hospital
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Periodontal Diseases