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Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

Primary Purpose

Sleep Bruxism, Sleep Bruxism, Childhood

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Intravascular Irradiation of Blood (ILIB)
Placebo Intravascular Irradiation of Blood (ILIB)
Orofacial Myofunctional Therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Bruxism

Eligibility Criteria

4 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • in the mixed dentition phase (permanent incisors and first molars erupted);
  • adolescents with an established permanent dentition.

Exclusion Criteria:

  • People with dental caries;
  • Those taking medications, such as inflammatory agents, muscle relaxants, corticosteroids, anticonvulsants, and antidepressants;
  • Those with chronic diseases that affect muscles or motor coordination, and those who do not cooperate during the evaluation will be excluded from the study;
  • Children with cerebral palsy;
  • Patients whose guardians do not sign the informed consent or the user does not sign the assent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Control Group

    ILIB Group

    Arm Description

    This group will receive an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.

    This group will receive an application of ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.

    Outcomes

    Primary Outcome Measures

    Changes in Oximetry
    A portable pulse oximeter that includes Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry under motion and low perfusion conditions will be used. Nocturnal oximetry will be performed prior to treatment and post treatment. The parents or guardians of the minor will be trained.

    Secondary Outcome Measures

    Changes in Breathing
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in breathing. It is the respiratory characterization from the taking of air, which explains the anatomical and topographical situation of its entrance to the respiratory system (respiratory mode), to the thoracoabdominal movement zone that integrates inspiration and expiration. It is supported by the observation with the aid of a Glatzel's mirror to anatomically determine the upper airway status and its functional correlation.
    Changes in Swallowing
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in swallowing. For this, the Payne's test, which assesses tongue posture both at rest and in function (swallowing), will be used. From instruments such as liquid fluorescein applied to the apex lingual and lateral borders, and Payne's lamp that verifies the vestige of the fluroscein, and therefore the conditions of support, thrust, position and/or obstruction of the tongue.
    Changes in Chewing
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in chewing. For this, the gnatodynamometer, test that allows to measure the force of the occlusion, will be used.
    Changes in Speech
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in speech. For this, the Glatzel test will be used to measure the degree of nasal patency and the functional symmetry of the upper airways both at rest and in function. Specifically in the functional evaluation, its usefulness is linked to the verification of the existence of nasality or hyponasality before vowels elicited by the patient.
    Changes in the Presence of Bruxism
    The bruxism questionnaire will be delivered to parents or guardians, which will be completed prior to treatment and afterwards. The questionnaire contains 4 questions regarding the perceived presence of bruxism, and 5 questions for the dentist to answer, based on a clinical observation. All questions have the options "yes" or "no". The more times the word "yes" is chosen, the greater the risk for bruxism is.
    Changes in Sleep Quality
    A Pediatric Sleep Quality Questionnaire will be delivered to parents or guardians, and it will be completed prior to treatment and afterwards. The questionnaire contains 44 questions regarding sleep quality. All questions have the options "yes" or "no". The more times the word "yes" is chosen, the worse is the sleep quality.

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    August 4, 2022
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05301452
    Brief Title
    Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism
    Official Title
    Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism - Study Protocol for a Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    June 20, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Background: The objective of this study will be to evaluate the effect of Intravascular Irradiation of Blood (ILIB) combined with myofunctional exercises for sleep bruxism in pediatrics. Methods: This study will be a randomized controlled clinical trial. A triage of individuals between 4 and 17 years old with a diagnosis of sleep bruxism will be carried out at the clinic of the Catholic University of Uruguay, and in a private office referred by different private care centers. The selected participants will be evaluated before and after treatment by means of questionnaires on bruxism, sleep quality and nocturnal oxygen saturation measurement. For this, 46 patients with sleep bruxism will be recruited, who will be divided into 2 groups: control group (CG), which will undergo an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol; and na ILIB group, which will carry out an active application of ILIB and an exercise protocol, this being once a week for 8 weeks. The laser treatment (808 nm) will be performed twice a week for 8 weeks. The values will be tested for normality by the Kolmogorov-Smirnov test. For the comparison between the groups, T-test will be carried out, considering a level of significance of 0.5% (p<0.05). Discussion: Although local photobiomodulation (PBM), acupuncture PBM and physiotherapy have been studied in the treatment of bruxism, this is the first study to evaluate the effect of ILIB combined with myofunctional exercises for sleep bruxism in pediatrics.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Bruxism, Sleep Bruxism, Childhood

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The participants will not know whether they belong to the placebo group, or the active photobiomodulation group, seeing as the laser application will be simulated.
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    This group will receive an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.
    Arm Title
    ILIB Group
    Arm Type
    Active Comparator
    Arm Description
    This group will receive an application of ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.
    Intervention Type
    Radiation
    Intervention Name(s)
    Intravascular Irradiation of Blood (ILIB)
    Intervention Description
    The laser treatment will be performed by a speech therapist and will have the following parameters: wavelength of 808 nm. It will be done twice a week for 8 weeks, in 20-minute sessions.
    Intervention Type
    Radiation
    Intervention Name(s)
    Placebo Intravascular Irradiation of Blood (ILIB)
    Intervention Description
    The photobiomodulation procedure will be simulated, but with the laser turned off. It will be done twice a week for 8 weeks, in 20-minute sessions.
    Intervention Type
    Procedure
    Intervention Name(s)
    Orofacial Myofunctional Therapy
    Intervention Description
    Myofunctional therapy will be performed by a speech therapist specialized in the area. It will consist of 1 weekly session, where the functions of breathing, chewing and swallowing will be evaluated and addressed. The following exercises will be indicated: nasal hygiene, inflated cheeks with the tip of the tongue on the palate, lingual sweep, tongue thrust against the palate, tongue touch on the last molars, chewing of soft solids and bolus assembly (20 minute therapy session).
    Primary Outcome Measure Information:
    Title
    Changes in Oximetry
    Description
    A portable pulse oximeter that includes Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry under motion and low perfusion conditions will be used. Nocturnal oximetry will be performed prior to treatment and post treatment. The parents or guardians of the minor will be trained.
    Time Frame
    Baseline and 8 weeks of treatment.
    Secondary Outcome Measure Information:
    Title
    Changes in Breathing
    Description
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in breathing. It is the respiratory characterization from the taking of air, which explains the anatomical and topographical situation of its entrance to the respiratory system (respiratory mode), to the thoracoabdominal movement zone that integrates inspiration and expiration. It is supported by the observation with the aid of a Glatzel's mirror to anatomically determine the upper airway status and its functional correlation.
    Time Frame
    Baseline and 8 weeks of treatment.
    Title
    Changes in Swallowing
    Description
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in swallowing. For this, the Payne's test, which assesses tongue posture both at rest and in function (swallowing), will be used. From instruments such as liquid fluorescein applied to the apex lingual and lateral borders, and Payne's lamp that verifies the vestige of the fluroscein, and therefore the conditions of support, thrust, position and/or obstruction of the tongue.
    Time Frame
    Baseline and 8 weeks of treatment.
    Title
    Changes in Chewing
    Description
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in chewing. For this, the gnatodynamometer, test that allows to measure the force of the occlusion, will be used.
    Time Frame
    Baseline and 8 weeks of treatment.
    Title
    Changes in Speech
    Description
    A clinical evaluation will be carried out by a speech therapist specialized in the area of Orofacial Motricity, to check for possible improvement in speech. For this, the Glatzel test will be used to measure the degree of nasal patency and the functional symmetry of the upper airways both at rest and in function. Specifically in the functional evaluation, its usefulness is linked to the verification of the existence of nasality or hyponasality before vowels elicited by the patient.
    Time Frame
    Baseline and 8 weeks of treatment.
    Title
    Changes in the Presence of Bruxism
    Description
    The bruxism questionnaire will be delivered to parents or guardians, which will be completed prior to treatment and afterwards. The questionnaire contains 4 questions regarding the perceived presence of bruxism, and 5 questions for the dentist to answer, based on a clinical observation. All questions have the options "yes" or "no". The more times the word "yes" is chosen, the greater the risk for bruxism is.
    Time Frame
    Baseline and 8 weeks of treatment.
    Title
    Changes in Sleep Quality
    Description
    A Pediatric Sleep Quality Questionnaire will be delivered to parents or guardians, and it will be completed prior to treatment and afterwards. The questionnaire contains 44 questions regarding sleep quality. All questions have the options "yes" or "no". The more times the word "yes" is chosen, the worse is the sleep quality.
    Time Frame
    Baseline and 8 weeks of treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: in the mixed dentition phase (permanent incisors and first molars erupted); adolescents with an established permanent dentition. Exclusion Criteria: People with dental caries; Those taking medications, such as inflammatory agents, muscle relaxants, corticosteroids, anticonvulsants, and antidepressants; Those with chronic diseases that affect muscles or motor coordination, and those who do not cooperate during the evaluation will be excluded from the study; Children with cerebral palsy; Patients whose guardians do not sign the informed consent or the user does not sign the assent.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36343030
    Citation
    Viarengo NO, Goncalves MLL, Bruno LH, Fossati AL, Sertaje MRF, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Evaluation of intravascular irradiation of blood in children with sleep bruxism: Study protocol for a randomized controlled clinical trial. Medicine (Baltimore). 2022 Nov 4;101(44):e31230. doi: 10.1097/MD.0000000000031230.
    Results Reference
    derived

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    Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

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