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Sleep BruxismPhase 1/2NCT01178229

Physiotherapy on the Airway of Bruxist Children

A Phase 1/2 study testing Physiotherapy in people with Sleep Bruxism and Airway Remodeling, run by CES University at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: to evaluate the effects of physiotherapy on the anteroposterior airway size in a group of bruxist children Question: Is a physiotherapeutic technique aiming at changing the head posture, effective to increase the anteroposterior dimensions of the upper airway in bruxist children? Hypothesis: The bruxist… Read more about this study

Who is it for?
Ages 3 to 6 years
What is being tested?
Physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteColombia
Study dates
Jan 2006to Nov 2007
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • All the children accomplished the minimal criteria of the International Classification of Sleep Disorders (ICSD) for sleep bruxism.
  • High anxiety level according to the Conners' Parents' Rating Scales.
  • Three to six year old.

Who cannot join

  • Skeletal malocclusions confirmed with cephalometric x-rays
  • Dental malocclusions confirmed with dental casts.
  • The reports of respiratory diseases.
  • Presence of mouth breathing.
  • Functional alterations in the body posture, due to any illness

Trial locations and contacts

1 site in 1 country.

Colombia1 site
  • CES Sabaneta Physiotheray Center

    Sabaneta, Antioquia

Other trials in Colombia

About this study

Official title: AWARNESS THROUGH MOVEMENT PHYSIOTERAPEUTIC TECHNIQUE INCREASED THE AIRWAY DIMENSIONS OF BRUXIST CHILDREN: A SINGLE BLIND RANDOMIZED CLINICAL TRIAL.

Objective: to evaluate the effects of physiotherapy on the anteroposterior airway size in a group of bruxist children

Question: Is a physiotherapeutic technique aiming at changing the head posture, effective to increase the anteroposterior dimensions of the upper airway in bruxist children?

Read more

Hypothesis: The bruxist children treated with physiotherapy will present higher airway dimensions

Design: randomized clinical trial with allocation and blinding of the examiners.

Participants: 3 to 6 year old children with complete primary dentition, dental and skeletal class I occlusion. The participants were classified as bruxist according to the minimal criteria of the ICSD for bruxism. The children were randomized in an experimental (n=13) and a control (n=13) group.

Intervention: A physiotherapeutic intervention using the Awareness through movement technique was applied to the children of the experimental group once a week, until 10 sessions were completed.

Outcome measures: anteroposterior measurements of the nasopharynx, oropharynx and hypopharynx taken in a lateral cephalogram with standardized techniques.

Read the detailed description

The physiotherapeutic intervention was based on the Awareness Through Movement (ATM) (Goldman 2003, Malmgren-Olson et al 2001) technique. It is an established method of movement re-education where coordination and posture are significant factors. Its proponents believe more effective and efficient actions can emerge from guided exploration of movement that promotes improved attention and awareness and refines the ability to detect information and make perceptual discriminations.

"Awareness through Movement" (ATM) (Stephens et al 2006) is a process which facilitates the learning of strategies for improving organization and coordination of body movement by developing spatial and kinesthetic awareness of body-segment relationships at rest and during motion, awareness of ease of movement, reducing effort in action, and increasing learning of feeling the muscles longer in action and while breathing .

Ten physiotherapeutic sessions were planed during a ten week period, all of them based in children games. Each session lasted three hours.

The children of the experimental group and their parents were guided by two expert physiotherapist previously standardized and the sessions took place in a room rounded by mirrors, where the children were able to see their own movements. The parents helped their own children during the session and in their home plan indicated weekly.

Each session pursued the following steps:

  1. Presentation to the parents of the somatic awareness technique for each day.
  2. Movements, games, motor tales and exercises performed by the children, guided by the parents and with the guide of the physiotherapists.
  3. In each session, a guide book with cartoons was given to the children and their parents to reinforce the exercises at home to keep a long-term result regarding the body and head posture. The guide book was designed and created by physiotherapists, teachers and advertisers that were not participating in the study.
  4. After the first session, a feedback was given before starting the next session, so the exercises at home and the difficulties were reviewed and solved.

All the children assisted together to all the sessions and the instructions and instruments given to the children and their parents were the same for all of them.

Error of method There were not statistically significant differences, regarding the age of the two groups.

Standardizations of the examiners and calibration of all the techniques to evaluate the children regarding the clinical examination and the physiotherapeutic evaluation were made on 12 subjects different from the ones included in the investigation. The Intratester (ICC> 0.9 2-way ANOVA) and intertester error (Kappa > 0.7) were not statistically significant.

A calibration of the x-ray technique and a standardization of the digital tracing of both the cephalogram were also performed. The tracing of the cephalogram was standardized between three investigators with 5 x-rays, scanned and traced two times each by each of three of the investigators. To determine the Intratester and intertester reliability, the intraclass correlation coefficient (ICC > 0.3) and Kappa test were applied.

A lateral cephalogram was taken before and immediately after the 10 session physiotherapeutic intervention for each child with the Natural Head Posture technique, described previously by different authors (Solow and Tallgren 1976). The technique is reproducible (Siersbaek-Nielsen and Solow 1982) and allows the clinician to evaluate the natural position of the cervical vertebras and the inclination of the cervical column and head posture.

Afterwards, the digital record of lateral cephalograms were processed in agree with Sayinsu et al 2006, using a program developed under Matlab 5.3 (MathWorks, Inc., MA. USA). Anteroposterior measurements of the nasopharynx, oropharynx and hypopharynx were taken in a lateral cephalogram with standardized techniques.

The method error ranged from 0.27 to 0.64 degrees and the coefficients of reliability from 0.97 to 1.00

Data analysis The sample size was calculated with a confidence of 95% and a statistical power of 80%. The number of subjects required in each group in order to make the comparisons was 12.

Distributions were tested using the Shapiro-Wilk test. The data were compared using the Mann Whitney and chi square tests. For all tests, significance was set at 5% (p < 0.05). Comparisons among and between groups were performed for all the variables (measurements of the airway) in order to answer the research question.

Results: Statistically significant increases were found for the measurements of the oropharynx (3 mm increase. 95% CI 0.22 to 0.32) and hypopharynx (3 mm increase 95% CI 0.11 to 0.20) for the children that received treatment with physiotherapy.

Conclusion: The physical therapy to change the head posture in bruxist children was useful to increase some of the dimensions of the airway in bruxist children.

Being tested
Physiotherapy
Keywords
Sleep bruxism, Airway remodeling, Physical therapy modalities, Child preschool.
Medical subject headings
Sleep Bruxism, Airway Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysiotherapyOther

    Also called Awareness through movement

    The physiotherapeutic intervention was based on the Awareness through Movement technique. Ten sessions were planed. Each session lasted three hours.

    The children of the experimental group and their parents were guided by two physiotherapist and the sessions took place in a room rounded by mirrors.

    Each session developed as follows: presentation to the parents of the somatic awareness technique for each day; movements, games, motor tales and exercises performed by the children; in each session, a guide book with cartoons was given to the children and their parents to reinforce the exercises at home to keep a long-term result.

    All the children assisted together to all the sessions and the instructions and instruments given to the children and their parents were the same for all of them.

Study groups in NCT01178229
Study groupRoleWhat they receive
PhysiotherapyExperimentalgroup of bruxist children that received physiotherapy to change the head posture
Receives: Other: Physiotherapy
ControlNo interventionGroup of bruxist children that did not receive treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ad1

    ad1: Distance between the posterior nasal spine (PNS) and basion (Ba) along the line which intersects the anterior and posterior pharyngeal wall.

    Measured: After 10 sessions of physiotherapy

  2. ad2

    ad2: Distance between the anterior and posterior pharyngeal wall traced perpendicular to the plane sella (S) Ba plane and passing through PNS.

    Measured: After the 10 sessions of physiotherapy

  3. Angle ad1-ad2

    Angle ad1-ad2: angle formed by ad1 and ad2.

    Measured: After 10 sessions of physiotherapy

  4. OAW1

    OAW1: the distance between the points where the functional occlusal plane intersects the anterior and posterior pharyngeal walls.

    Measured: After 10 sessions of physiotherapy

  5. OAW2

    OAW2: the distance between points where a line passing through hyoid (hy) and C2 i intersects the anterior and posterior pharyngeal walls.

    Measured: After 10 sessions of physiotherapy

  6. OAW3

    OAW3: the distance between the points where a line passing through hy and C4 i intersects the anterior and posterior pharyngeal walls.

    Measured: After 10 sessions of physiotherapy

  7. Angle OAW2-OAW3

    Angle OAW2-OAW3: angle formed by OAW2 and OAW3.

    Measured: After 10 sessions of physiotherapy

  8. SPPS

    SPPS: anteroposterior dimension of the pharynx measured between the posterior pharyngeal wall and the dorsum of the soft palate on a line parallel to the Frankfort horizontal (FH) plane that runs through the middle of a line from PNS to the distal extreme of the soft palate (P).

    Measured: After 10 sessions of physiotherapy

  9. IPS

    IPS: anteroposterior dimension of the pharynx measured between the posterior pharyngeal wall and the dorsum of the tongue on a line parallel to the FH plane that runs through C2i

    Measured: after 10 sessions of physiotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2010 (estimated)
  2. Study startJan 2006
  3. Primary completionJun 2007
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01178229
Sponsor's protocol ID
via aerea 01
Status last verified
Jul 2006
First submitted
5 Aug 2010
Last updated
10 Aug 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Physiotherapy in people with Sleep Bruxism and Airway Remodeling, run by CES University at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ad1 (time frame: After 10 sessions of physiotherapy). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.

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