Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Physiotherapy on the Airway of Bruxist Children

This study has been completed.
Sponsor:
Information provided by:
CES University
ClinicalTrials.gov Identifier:
NCT01178229
First received: August 5, 2010
Last updated: August 9, 2010
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Sleep Bruxism
Airway Remodeling
Physical Therapy Modalities
Other: Physiotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AWARNESS THROUGH MOVEMENT PHYSIOTERAPEUTIC TECHNIQUE INCREASED THE AIRWAY DIMENSIONS OF BRUXIST CHILDREN: A SINGLE BLIND RANDOMIZED CLINICAL TRIAL.

Resource links provided by NLM:


Further study details as provided by CES University:

Primary Outcome Measures:
  • ad1 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    ad1: Distance between the posterior nasal spine (PNS) and basion (Ba) along the line which intersects the anterior and posterior pharyngeal wall.

  • ad2 [ Time Frame: After the 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    Angle ad1-ad2: angle formed by ad1 and ad2.

  • OAW1 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    OAW1: the distance between the points where the functional occlusal plane intersects the anterior and posterior pharyngeal walls.

  • OAW2 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    OAW2: the distance between points where a line passing through hyoid (hy) and C2 i intersects the anterior and posterior pharyngeal walls.

  • OAW3 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    Angle OAW2-OAW3: angle formed by OAW2 and OAW3.

  • SPPS [ Time Frame: After 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: after 10 sessions of physiotherapy ] [ Designated as safety issue: Yes ]
    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


Enrollment: 26
Study Start Date: January 2006
Estimated Study Completion Date: November 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physiotherapy
group of bruxist children that received physiotherapy to change the head posture
Other: Physiotherapy

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.

Other Name: Awareness through movement
No Intervention: Control
Group of bruxist children that did not receive treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178229

Locations
Colombia
CES Sabaneta Physiotheray Center
Sabaneta, Antioquia, Colombia
Sponsors and Collaborators
CES University
Investigators
Principal Investigator: Claudia Restrepo, DDS Director CES-LPH Research Group
  More Information

No publications provided

Responsible Party: Claudia Restrepo, Director CES-LPH Research Group. CES University
ClinicalTrials.gov Identifier: NCT01178229     History of Changes
Other Study ID Numbers: via aerea 01
Study First Received: August 5, 2010
Last Updated: August 9, 2010
Health Authority: Colombia: National Institutes of Health

Keywords provided by CES University:
Sleep bruxism
Airway remodeling
Physical therapy modalities
Child preschool.

Additional relevant MeSH terms:
Airway Remodeling
Bruxism
Sleep Bruxism
Mental Disorders
Nervous System Diseases
Parasomnias
Pathological Conditions, Anatomical
Sleep Disorders
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on November 20, 2014