<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/NCT04487418</url>
  </required_header>
  <id_info>
    <org_study_id>lingualfrenotomy</org_study_id>
    <nct_id>NCT04487418</nct_id>
  </id_info>
  <brief_title>Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants</brief_title>
  <official_title>Evaluation of the Effects of High-level Laser and Electro-cautery in Lingual Frenotomy Surgeries in Infants - Blinded Randomized Controlled Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</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>
      Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin&#xD;
      lingual frenulum that can restrict the movements of the tongue and has been identified as one&#xD;
      of the factors that can negatively interfere with breastfeeding, decreasing the ability of&#xD;
      the newborn to make a clamp proper. According to the Ministry of Health in Brazil, the&#xD;
      percentage of newborns who present this anomaly is 3% to 16%. The objective of the study will&#xD;
      be to evaluate the release of the lingual frenulum through the lingual frenotomy performed&#xD;
      with a high level diode laser or with an electro cautery. Methods: The present study will be&#xD;
      a blind randomized controlled clinical trial, in which 56 volunteers, infants aged 0 to 3&#xD;
      months, with normal health status, who are breastfeeding, diagnosed with ankyloglossia and&#xD;
      indication for surgery, will do lingual frenotomy. Those responsible for the children will be&#xD;
      informed about the study procedures and after signing the Free and Informed Consent Form,&#xD;
      authorizing them to participate in the study. The non-blinded researcher will conduct the&#xD;
      evaluation, screening and procedures, and another blinded researcher will be the evaluator 15&#xD;
      days after the procedure. The distribution of volunteers in the groups will be random and&#xD;
      randomized: Surgery Group with electro cautery (G1- EC) and Surgery Group with high power&#xD;
      diode laser (G2-L). The procedures for patient preparation, asepsis and infection control&#xD;
      will be strictly followed in accordance with biosafety rules. In both groups the infants will&#xD;
      be submitted to anamnesis, clinical evaluation and standardized photograph of the lingual&#xD;
      frenulum region before the surgical procedure and application of the Bristol frenulum&#xD;
      evaluation protocol, the nursing mother will be submitted to the evaluation of the VAS of&#xD;
      pain during breastfeeding, before, shortly after and 15 days after the surgical procedure for&#xD;
      the evaluation of the result of the lingual frenotomy. Discussion: Ankyloglossia can&#xD;
      negatively impact breastfeeding. The lingual frenotomy procedure can be performed using&#xD;
      various surgical techniques. The use of high-power laser for this purpose has been identified&#xD;
      as an effective resource in the incision of the lingual frenulum, with advantages in the&#xD;
      trans-operative period, less bleeding and better visualization of the surgical field, and in&#xD;
      the post-operative period, with reduction of edema, pain and inflammation, quality of tissue&#xD;
      repair and patient comfort.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 3, 2020</start_date>
  <completion_date type="Anticipated">November 3, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</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>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Photograph of the lingual brake region</measure>
    <time_frame>10 minutes</time_frame>
    <description>An intraoral photograph will be performed on the planes: frontal, median sagittal of the patient, parallel to the vertical edges and occlusal to the horizontal edges with the focus on the lingual brake region. The evaluation will be performed after the surgical procedure, and after 15 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BRISOL</measure>
    <time_frame>15 minutes</time_frame>
    <description>The baby will be placed on the lap of one of the guardians, adult, in the supine position, who in turn is lying in the dental chair, in some situations the knee-to-knee position may be used, and the professional should assess which will be more convenient for stabilization. protective of the patient.&#xD;
asepsis and infection control for the patient, will be strictly followed in accordance with Biosafety rules.&#xD;
In the Bristol protocol we will have a final score based on 4 points to observe: appearance of the tip of the tongue, fixation of the brake in the lower alveolus, elevation of the tongue during crying and protrusion of the tongue on the gums The evaluation will be carried out immediately after the surgery and after 15 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>The application of the VAS pain scale will be applied to the nursing mother during breastfeeding before, shortly after and 15 days after the surgical procedure. During breastfeeding, the nursing mother will be asked about the pain in the breasts, and she must report the pain by looking at the scale mentioned, from 0 to 10 and choose the number that most relates to breast pain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Lingual Frenum</condition>
  <condition>High Power Laser</condition>
  <condition>Breast Feeding</condition>
  <arm_group>
    <arm_group_label>Surgery group with electro cautery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgery will be performed with electro cautery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High level diode laser surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High power diode laser surgery will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electro cautery surgery</intervention_name>
    <description>Pre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline).&#xD;
The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery.&#xD;
Postoperative care:&#xD;
Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.</description>
    <arm_group_label>Surgery group with electro cautery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High power diode laser surgery</intervention_name>
    <description>Pre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator.&#xD;
Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.</description>
    <arm_group_label>High level diode laser surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  0 to 3 months old&#xD;
&#xD;
          -  Infants born within normal health standards&#xD;
&#xD;
          -  Infants who are breastfeeding&#xD;
&#xD;
          -  Have a diagnosis of ankyloglossia with a score of 0 to 4 according to the Bristol&#xD;
             protocol, performed by a Speech Therapist and / or Dental Surgeon and / or&#xD;
             Pediatrician.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with changes:&#xD;
&#xD;
          -  Congenital and systemic&#xD;
&#xD;
          -  Blood dyscrasias&#xD;
&#xD;
          -  Hemophilia, diabetes&#xD;
&#xD;
          -  Nutritional weaknesses&#xD;
&#xD;
          -  Imunodeficiencies&#xD;
&#xD;
          -  Changes in the oral cavity&#xD;
&#xD;
          -  Infants who are under medical treatment&#xD;
&#xD;
          -  Use of medication&#xD;
&#xD;
          -  Do not be well on the day of the surgical procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </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/NCT04487418
org study id: lingualfrenotomy
nct id: NCT04487418
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Ankyloglossia is an anomaly that is characterized by an abnormally short, thick or thin
      lingual frenulum that can restrict the movements of the tongue and has been identified as one
      of the factors that can negatively interfere with breastfeeding, decreasing the ability of
      the newborn to make a clamp proper. According to the Ministry of Health in Brazil, the
      percentage of newborns who present this anomaly is 3% to 16%. The objective of the study will
      be to evaluate the release of the lingual frenulum through the lingual frenotomy performed
      with a high level diode laser or with an electro cautery. Methods: The present study will be
      a blind randomized controlled clinical trial, in which 56 volunteers, infants aged 0 to 3
      months, with normal health status, who are breastfeeding, diagnosed with ankyloglossia and
      indication for surgery, will do lingual frenotomy. Those responsible for the children will be
      informed about the study procedures and after signing the Free and Informed Consent Form,
      authorizing them to participate in the study. The non-blinded researcher will conduct the
      evaluation, screening and procedures, and another blinded researcher will be the evaluator 15
      days after the procedure. The distribution of volunteers in the groups will be random and
      randomized: Surgery Group with electro cautery (G1- EC) and Surgery Group with high power
      diode laser (G2-L). The procedures for patient preparation, asepsis and infection control
      will be strictly followed in accordance with biosafety rules. In both groups the infants will
      be submitted to anamnesis, clinical evaluation and standardized photograph of the lingual
      frenulum region before the surgical procedure and application of the Bristol frenulum
      evaluation protocol, the nursing mother will be submitted to the evaluation of the VAS of
      pain during breastfeeding, before, shortly after and 15 days after the surgical procedure for
      the evaluation of the result of the lingual frenotomy. Discussion: Ankyloglossia can
      negatively impact breastfeeding. The lingual frenotomy procedure can be performed using
      various surgical techniques. The use of high-power laser for this purpose has been identified
      as an effective resource in the incision of the lingual frenulum, with advantages in the
      trans-operative period, less bleeding and better visualization of the surgical field, and in
      the post-operative period, with reduction of edema, pain and inflammation, quality of tissue
      repair and patient comfort.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Photograph of the lingual brake region
time frame: 10 minutes
description: An intraoral photograph will be performed on the planes: frontal, median sagittal of the patient, parallel to the vertical edges and occlusal to the horizontal edges with the focus on the lingual brake region. The evaluation will be performed after the surgical procedure, and after 15 days.
measure: BRISOL
time frame: 15 minutes
description: The baby will be placed on the lap of one of the guardians, adult, in the supine position, who in turn is lying in the dental chair, in some situations the knee-to-knee position may be used, and the professional should assess which will be more convenient for stabilization. protective of the patient.
asepsis and infection control for the patient, will be strictly followed in accordance with Biosafety rules.
In the Bristol protocol we will have a final score based on 4 points to observe: appearance of the tip of the tongue, fixation of the brake in the lower alveolus, elevation of the tongue during crying and protrusion of the tongue on the gums The evaluation will be carried out immediately after the surgery and after 15 days.
measure: Visual analogue scale (VAS)
time frame: 10 minutes
description: The application of the VAS pain scale will be applied to the nursing mother during breastfeeding before, shortly after and 15 days after the surgical procedure. During breastfeeding, the nursing mother will be asked about the pain in the breasts, and she must report the pain by looking at the scale mentioned, from 0 to 10 and choose the number that most relates to breast pain.
arm group label: Surgery group with electro cautery
arm group type: Experimental
description: Surgery will be performed with electro cautery.
arm group label: High level diode laser surgery
arm group type: Experimental
description: High power diode laser surgery will be performed.
intervention type: Procedure
intervention name: Electro cautery surgery
description: Pre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline).
The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery.
Postoperative care:
Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
arm group label: Surgery group with electro cautery
intervention type: Procedure
intervention name: High power diode laser surgery
description: Pre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator.
Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt.
arm group label: High level diode laser surgery
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Months
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Professor
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)