NCT01178229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

August 10, 2010

Status Verified

July 1, 2006

Enrollment Period

1.4 years

First QC Date

August 5, 2010

Last Update Submit

August 9, 2010

Conditions

Keywords

Sleep bruxismAirway remodelingPhysical therapy modalitiesChild preschool.

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • Angle ad1-ad2

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

    After 10 sessions of physiotherapy

  • OAW1

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

    After 10 sessions of physiotherapy

  • 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

  • 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

  • Angle OAW2-OAW3

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

    After 10 sessions of physiotherapy

  • 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

  • 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

Study Arms (2)

Physiotherapy

EXPERIMENTAL

group of bruxist children that received physiotherapy to change the head posture

Other: Physiotherapy

Control

NO INTERVENTION

Group of bruxist children that did not receive treatment

Interventions

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.

Also known as: Awareness through movement
Physiotherapy

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CES Sabaneta Physiotheray Center

Sabaneta, Antioquia, Colombia

Location

MeSH Terms

Conditions

Sleep BruxismAirway Remodeling

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Claudia Restrepo, DDS

    Director CES-LPH Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 10, 2010

Study Start

January 1, 2006

Primary Completion

June 1, 2007

Study Completion

November 1, 2007

Last Updated

August 10, 2010

Record last verified: 2006-07

Locations