Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder
9 september 2015 bijgewerkt door: Simone Saldanha Ignacio de Oliveira, University of Sao Paulo
Evaluation of Postural Balance in Individuals With Temporomandibular Disorder by Means of Force Platform After Using Occlusal Stabilizer Splint Disorder
To investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
The research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and magnetic resonance imaging of the temporomandibular joints.
The research is a randomized, controlled, prospective clinical study with intervention.
Postural equilibrium will be evaluated by means of a force plate.
In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises.
After 12 weeks, the groups were re-evaluated.
The results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of 0.05.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
approved 06/29/2011
Studietype
Ingrijpend
Inschrijving (Werkelijk)
49
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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São Paulo/SP
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São Paulo, São Paulo/SP, Brazilië, 05508-900
- Universidade de São Paulo
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Diagnostic Criteria Temporomandibular Disorders and dentate subjects
Exclusion Criteria:
- Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: therapeutic exercises
13 as control group - The control group got only orientation related to therapeutic exercises.The orientation for therapeutic exercises seek to correctly position the jaw in the resting position.
Maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
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The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
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|
Experimenteel: occlusal plate group
36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria.
The patients also received therapeutic exercises too.
The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
|
The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises.
The patient was instructed to perform 15 repetitions 3 times a day.
In the plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day. The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
Tijdsspanne: twelve weeks
|
Postural equilibrium was evaluated by means of a force plate.
In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation related to therapeutic exercises.
|
twelve weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Simone de Oliveira, PHD, University of Sao Paulo
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2011
Primaire voltooiing (Werkelijk)
1 december 2011
Studie voltooiing (Werkelijk)
1 december 2012
Studieregistratiedata
Eerst ingediend
6 november 2013
Eerst ingediend dat voldeed aan de QC-criteria
24 september 2014
Eerst geplaatst (Schatting)
26 september 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
10 september 2015
Laatste update ingediend die voldeed aan QC-criteria
9 september 2015
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Gewrichtsziekten
- Musculoskeletale aandoeningen
- Spierziekten
- Stomatognatische ziekten
- Kaak Ziekten
- Craniomandibulaire aandoeningen
- Mandibulaire aandoeningen
- Myofasciale pijnsyndromen
- Ziekte
- Temporomandibulaire gewrichtsaandoeningen
- Temporomandibulair gewrichtsdisfunctiesyndroom
- Anti-infectieuze middelen
- Dermatologische middelen
- Antischimmelmiddelen
- Keratolytische middelen
- Salicylzuur
Andere studie-ID-nummers
- Postural balance
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