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
About this trial
This is an interventional treatment trial for Sleep Bruxism
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.
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
NCT ID
NCT05301452
First Posted
March 16, 2022
Last Updated
August 4, 2022
Sponsor
University of Nove de Julho
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
Learn more about this trial
Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism
We'll reach out to this number within 24 hrs