- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04211870
Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism
February 11, 2020 updated by: Sandra Kalil Bussadori, University of Nove de Julho
Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial
Hypotonia, particularly of the masticatory and oropharyngeal muscles, is one of the main characteristics of Down syndrome, resulting in impaired speech, chewing and swallowing.
Moreover, the complete or partial obstruction of the airways during sleep may occur due to hypotonia of the tongue, leading to snoring and sleep disorders, such as obstructive apnea and sleep bruxism.
Objectives: Analyze salivary levels of dopamine and cortisol and muscle activity before and after treatment with low-level laser therapy administered to acupoints in children with Down syndrome.
Methods: A randomized, controlled, clinical trial will be conducted.
Individuals four to 17 years of age with a diagnosis of Down syndrome and possible sleep bruxism will be screened at the Integrated Health Clinic of Nove de Julho University.
We will evaluate orofacial dysfunction (NOT-S questionnaire), facial sensitivity, activity of the masticatory and trapezius muscles (electromyography), head posture as well as salivary cortisol and dopamine.
After the evaluations, the participants will be randomized into two groups: Grupo 1 - treatment with low-level laser therapy at a wavelength of 808 nm; Group 2 - sham treatment (simulated laser therapy).
Treatment will be conducted twice per week for a total of 12 sessions.
The data will be tabulated and treated using GraphPad Prism version 7.0.
The Kolmogorov-Smirnov test will be used to determine the normality of the data.
Variables that fit the Gaussian curve will be expressed as mean and standard deviation.
The t-test will be used for comparisons between the groups, with the significance level set to 5% (p <0.05).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children and adolescents with a diagnosis of Down syndrome
- Four to 17 years of age
- Bruxism, based on parental reports of the occurrence of grinding the teeth, incisal and/or occlusal tooth wear following the criteria of the American Academy of Sleep Medicine (AASM) and the questionnaire for the evaluation of bruxism validated by Serra Negra et al. (2014) and a systematic review performed by Manfredini et al. (2013).
Exclusion Criteria:
- Use of muscle relaxant
- Temporomandibular disorder
- Undergoing other therapy for bruxism
- Other associated neurological diseases
- Cognitive deficit that impedes understanding the evaluations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1
Treatment with low-level laser therapy.
|
Sessions will be held twice a week for six weeks (total: 12 session).
A potentiometer will be used to measure the mean power of the equipment and therapeutic dose, ensuring safety to the participant and operator.
Laser will be administered at a wavelength of 786.94 nm using an energy density of 2 J/cm², intensity of 1.675 mW/cm² and power of 70 mW (0.070 W) for 20 seconds per point.
The point application method will be used with a conventional tip in contact with the skin (spot area: 0.04 cm²) following the protocol suggested by Venezian et al.59 and Carvalho et al.60.
|
Sham Comparator: Group 2
Sham treatment (simulated laser therapy).
|
Sessions will be held twice a week for six weeks (total: 12 session).
During sham treatment the device will emit a guide light and sound, but no energy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in salivary cortisol
Time Frame: Baseline and 15 days follow-up.
|
Cortisol will be measured from saliva samples.
Non-stimulated saliva will be collected in the morning or afternoon with the participant fasting or at least two hours since the last meal.
The participant will be seated comfortably in a well-ventilated environment with the head inclined slightly forward without swallowing to allow saliva to accumulate on the floor of the mouth.
The saliva will be expelled for a period of five minutes into a funnel coupled to previously weighed tube partially immersed in crushed ice.
Salivary flow will be calculated as mL/min.
Two mL of saliva will be collected.
The samples will be transported under refrigeration to the Cellular Culture and Research Lab of Nove de Julho University (Vergueiro campus) for centrifugation (5000 g, 5 min, 4°C) and storage at -80°C.
The material will be discarded after use.
|
Baseline and 15 days follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in salivary dopamine
Time Frame: Baseline and 15 days follow-up.
|
Dopamine will be measured from saliva samples.
Non-stimulated saliva will be collected in the morning or afternoon with the participant fasting or at least two hours since the last meal.
The participant will be seated comfortably in a well-ventilated environment with the head inclined slightly forward without swallowing to allow saliva to accumulate on the floor of the mouth.
The saliva will be expelled for a period of five minutes into a funnel coupled to previously weighed tube partially immersed in crushed ice.
Salivary flow will be calculated as mL/min.
Two mL of saliva will be collected.
The samples will be transported under refrigeration to the Cellular Culture and Research Lab of Nove de Julho University (Vergueiro campus) for centrifugation (5000 g, 5 min, 4°C) and storage at -80°C.
The material will be discarded after use.
|
Baseline and 15 days follow-up.
|
Sensory evaluation/monofilaments
Time Frame: Baseline and 15 days follow-up.
|
The sensory evaluation will be performed using the Semmes-Weinstein kit (Smiles®), which contains a set of six nylon monofilaments (esthesiometry) of the same length that exert pressure on the specific site of the skin tested.
Each monofilament has a specific color and diameter: green (0.05 g), blue (0.2 g), violet (2 g), red (4 g), orange (10 g) and magenta (300 g) 16.
The test will be performed on dermatomes.
The score ranges from seven (green monofilament) to 1 (magenta monofilament).18
|
Baseline and 15 days follow-up.
|
Head posture assessment
Time Frame: Baseline and 15 days follow-up.
|
The clinical (visual) assessment of head posture will be performed using a posture grid.
The participant will be instructed to stand with his/her natural posture.
The natural balance of the head will be used to standardize the posture of each subject, who will be instructed to look forward with the gaze on the horizon.
Semi-spherical polystyrene markers measuring 1.5 cm in diameter will be attached to the skin with double-sided adhesive tape at three anatomic points: the spiny process of the seventh cervical vertebra (C7), the manubrium of the sternum (A1) and the mental protuberance (MP).
Photographs will be taken of each participant in right-side view.
|
Baseline and 15 days follow-up.
|
Orofacial Evaluation Through NOT-S (score from 0 to 12)
Time Frame: Baseline and 15 days follow-up.
|
The following functions are addressed during the interview: (I) sensory function, (II) breathing, (III) habits, (IV) chewing and swallowing, (V) drooling and (VI) dryness of the mouth.
The following functions are evaluated during the physical examination: (1) face at rest, (2) nose breathing, (3) facial expression, (4) masticatory muscle and jaw function, (5) oral motor function and (6) speech.
For the evaluation of orofacial dysfunction during the clinical examination, the participants will be asked to perform tasks for each item in accordance with the illustrated manual.
Each item has criteria for the respective function.
A "YES" response or task the meets the criteria for compromised function will be scored 1 point, indicating dysfunction in the respective domain.
A "NO" response or task that does not meet the criteria will be scored zero.
The total is the sum of the points of all domains and ranges from 0 to 12, with higher scores denoting greater orofacial disfunction.
|
Baseline and 15 days follow-up.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 20, 2020
Primary Completion (Anticipated)
November 20, 2020
Study Completion (Anticipated)
December 20, 2020
Study Registration Dates
First Submitted
December 19, 2019
First Submitted That Met QC Criteria
December 23, 2019
First Posted (Actual)
December 26, 2019
Study Record Updates
Last Update Posted (Actual)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Wake Disorders
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Parasomnias
- Intellectual Disability
- Tooth Diseases
- Abnormalities, Multiple
- Chromosome Disorders
- Bruxism
- Down Syndrome
- Sleep Bruxism
Other Study ID Numbers
- Monica
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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