Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation
5. april 2017 oppdatert av: Maximiliano Sergio Cenci, Federal University of Pelotas
Evaluation of Mandibular Movements and Condyle-fossa Relation From Two Treatment Protocols. A Randomized Clinical Trial.
The edentulism and use of inadequate dentures, unstable and with teeth worn because long period of usage can lead to an disharmony of the stomatognathic system due to gradual loss of occlusion vertical dimension resulting in inadequate mandibular movements and condyle-fossa relation.
The reline of the denture base and the use of interocclusal appliance prior to definitive rehabilitation could have influence on these functional aspects.
However, there are not Randomized Controlled clinical Trials (RCTs) testing the combined use of these two treatments in reestablishing these functional aspects.
The, aim of this study is to evaluate whether the denture base reline and the use of interocclusal appliance prior to final rehabilitation have influence on mandibular movements and condyle-fossa relation, incomplete denture wearers.
For this controlled, crossover, randomized and blinded clinical trial, 30 volunteers, totally edentulous, complete denture wearer over a period of five year, will be selected.
The volunteers will be randomly allocated into three subgroups (n= 10) and will receive the following treatments: Control (C)Volunteers will receive new complete denture without any previous intervention in their old complete denture; Relining Denture (RD)Volunteers will be submitted to the relining of the base of the their old complete denture and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed; Interocclusal Appliance (IA) Volunteers will be submitted to the treatment with interocclusal appliance and after 30 days of usage and before the replacement of the new complete denture, an evaluation will be performed.
Volunteers will be evaluated regarding the extent of mandibular movement by intraoral record of Gothic Gysi arch; condyle-fossa relation by cone-bean computed tomographic scan; occlusion vertical dimension by Willis compass and photographic record.
These evaluations will be performed at three periods, T0 baseline; T1 after application of randomized treatment, reline denture and interocclusal appliance); T3 after final rehabilitation.
The control group will be evaluated only at periods T0 and T3.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Rio Grande do Sul
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Pelotas, Rio Grande do Sul, Brasil, 96015-560
- School of Dentistry, Federal University of Pelotas
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
45 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
- Have availability to attend FO / UFPel days predetermined;
- Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.
Exclusion Criteria:
- Patients younger than 40 years;
- Patients who are not users of denture upper and lower;
- Patients denture wearers during periods of less than five years.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
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Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
All patients will be rehabilitated with new complete dentures in the study
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Eksperimentell: Relining complete denture base
Patients will be submitted to a procedure of relining their old dentures 30 days before the replacement of the complete dentures.
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All patients will be rehabilitated with new complete dentures in the study
Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
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Aktiv komparator: Only Rehabilitation
Patients will be treated with a complete denture without any kind of previous intervention
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All patients will be rehabilitated with new complete dentures in the study
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Change from baseline of the occlusal vertical dimension after treatment at 6 months
Tidsramme: 30 days after randomization; and 30 days after final prosthetic rehabilitation
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30 days after randomization; and 30 days after final prosthetic rehabilitation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in the extension of the mandibular movements up to 6 months.
Tidsramme: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
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The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
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30 days after randomization; and 30 days after the final prosthetic rehabilitation
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change from baseline in the condyle-fossa relation up to six months
Tidsramme: 30 days after randomization; and 30 days after the final prosthetic rehabilitation
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The condyle-fossa relation will be measured by cone-bean computed tomographic scan.
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30 days after randomization; and 30 days after the final prosthetic rehabilitation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. august 2013
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Forventet)
1. desember 2017
Datoer for studieregistrering
Først innsendt
13. september 2013
Først innsendt som oppfylte QC-kriteriene
13. desember 2013
Først lagt ut (Anslag)
19. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. april 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PPGO0014
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