Physical Therapy Modalities Clinical Trial
Official title:
AWARNESS THROUGH MOVEMENT PHYSIOTERAPEUTIC TECHNIQUE INCREASED THE AIRWAY DIMENSIONS OF BRUXIST CHILDREN: A SINGLE BLIND RANDOMIZED CLINICAL TRIAL.
Verified date | July 2006 |
Source | CES University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: National Institutes of Health |
Study type | Interventional |
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 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.
Status | Completed |
Enrollment | 26 |
Est. completion date | November 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 6 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Colombia | CES Sabaneta Physiotheray Center | Sabaneta | Antioquia |
Lead Sponsor | Collaborator |
---|---|
CES University |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ad1 | ad1: Distance between the posterior nasal spine (PNS) and basion (Ba) along the line which intersects the anterior and posterior pharyngeal wall. | After 10 sessions of physiotherapy | Yes |
Primary | ad2 | ad2: Distance between the anterior and posterior pharyngeal wall traced perpendicular to the plane sella (S) Ba plane and passing through PNS. | After the 10 sessions of physiotherapy | Yes |
Primary | Angle ad1-ad2 | Angle ad1-ad2: angle formed by ad1 and ad2. | After 10 sessions of physiotherapy | Yes |
Primary | OAW1 | OAW1: the distance between the points where the functional occlusal plane intersects the anterior and posterior pharyngeal walls. | After 10 sessions of physiotherapy | Yes |
Primary | OAW2 | OAW2: the distance between points where a line passing through hyoid (hy) and C2 i intersects the anterior and posterior pharyngeal walls. | After 10 sessions of physiotherapy | Yes |
Primary | OAW3 | OAW3: the distance between the points where a line passing through hy and C4 i intersects the anterior and posterior pharyngeal walls. | After 10 sessions of physiotherapy | Yes |
Primary | Angle OAW2-OAW3 | Angle OAW2-OAW3: angle formed by OAW2 and OAW3. | After 10 sessions of physiotherapy | Yes |
Primary | 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). | After 10 sessions of physiotherapy | Yes |
Primary | 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 | after 10 sessions of physiotherapy | Yes |
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