Physiotherapy on the Airway of Bruxist Children
Primary Purpose
Sleep Bruxism, Airway Remodeling, Physical Therapy Modalities
Status
Completed
Phase
Phase 1
Locations
Colombia
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Bruxism focused on measuring Sleep bruxism, Airway remodeling, Physical therapy modalities, Child preschool.
Eligibility Criteria
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
Sites / Locations
- CES Sabaneta Physiotheray Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Physiotherapy
Control
Arm Description
group of bruxist children that received physiotherapy to change the head posture
Group of bruxist children that did not receive treatment
Outcomes
Primary Outcome Measures
ad1
ad1: Distance between the posterior nasal spine (PNS) and basion (Ba) along the line which intersects the anterior and posterior pharyngeal wall.
ad2
ad2: Distance between the anterior and posterior pharyngeal wall traced perpendicular to the plane sella (S) Ba plane and passing through PNS.
Angle ad1-ad2
Angle ad1-ad2: angle formed by ad1 and ad2.
OAW1
OAW1: the distance between the points where the functional occlusal plane intersects the anterior and posterior pharyngeal walls.
OAW2
OAW2: the distance between points where a line passing through hyoid (hy) and C2 i intersects the anterior and posterior pharyngeal walls.
OAW3
OAW3: the distance between the points where a line passing through hy and C4 i intersects the anterior and posterior pharyngeal walls.
Angle OAW2-OAW3
Angle OAW2-OAW3: angle formed by OAW2 and OAW3.
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).
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01178229
Brief Title
Physiotherapy on the Airway of Bruxist Children
Official Title
AWARNESS THROUGH MOVEMENT PHYSIOTERAPEUTIC TECHNIQUE INCREASED THE AIRWAY DIMENSIONS OF BRUXIST CHILDREN: A SINGLE BLIND RANDOMIZED CLINICAL TRIAL.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
November 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
CES University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
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:
Presentation to the parents of the somatic awareness technique for each day.
Movements, games, motor tales and exercises performed by the children, guided by the parents and with the guide of the physiotherapists.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism, Airway Remodeling, Physical Therapy Modalities
Keywords
Sleep bruxism, Airway remodeling, Physical therapy modalities, Child preschool.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
group of bruxist children that received physiotherapy to change the head posture
Arm Title
Control
Arm Type
No Intervention
Arm Description
Group of bruxist children that did not receive treatment
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Awareness through movement
Intervention Description
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.
Primary Outcome Measure Information:
Title
ad1
Description
ad1: Distance between the posterior nasal spine (PNS) and basion (Ba) along the line which intersects the anterior and posterior pharyngeal wall.
Time Frame
After 10 sessions of physiotherapy
Title
ad2
Description
ad2: Distance between the anterior and posterior pharyngeal wall traced perpendicular to the plane sella (S) Ba plane and passing through PNS.
Time Frame
After the 10 sessions of physiotherapy
Title
Angle ad1-ad2
Description
Angle ad1-ad2: angle formed by ad1 and ad2.
Time Frame
After 10 sessions of physiotherapy
Title
OAW1
Description
OAW1: the distance between the points where the functional occlusal plane intersects the anterior and posterior pharyngeal walls.
Time Frame
After 10 sessions of physiotherapy
Title
OAW2
Description
OAW2: the distance between points where a line passing through hyoid (hy) and C2 i intersects the anterior and posterior pharyngeal walls.
Time Frame
After 10 sessions of physiotherapy
Title
OAW3
Description
OAW3: the distance between the points where a line passing through hy and C4 i intersects the anterior and posterior pharyngeal walls.
Time Frame
After 10 sessions of physiotherapy
Title
Angle OAW2-OAW3
Description
Angle OAW2-OAW3: angle formed by OAW2 and OAW3.
Time Frame
After 10 sessions of physiotherapy
Title
SPPS
Description
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).
Time Frame
After 10 sessions of physiotherapy
Title
IPS
Description
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
Time Frame
after 10 sessions of physiotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Restrepo, DDS
Organizational Affiliation
Director CES-LPH Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
CES Sabaneta Physiotheray Center
City
Sabaneta
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
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Physiotherapy on the Airway of Bruxist Children
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