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Evaluation of Influence of Two Treatment Protocols on Mandibular Movements and Condyle-fossa Relation

5. april 2017 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Rio Grande do Sul
      • Pelotas, Rio Grande do Sul, Brasilien, 96015-560
        • School of Dentistry, Federal University of Pelotas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Healthy adults suffering from upper and lower denture indicated for replacement due to use exceeding five years;
  2. Have availability to attend FO / UFPel days predetermined;
  3. Agree with the term informed consent, approved by the research ethics committee of FO / UFPel.

Exclusion Criteria:

  1. Patients younger than 40 years;
  2. Patients who are not users of denture upper and lower;
  3. Patients denture wearers during periods of less than five years.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Interocclusal appliance
Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
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
Eksperimentel: 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.
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.
Aktiv komparator: Only Rehabilitation
Patients will be treated with a complete denture without any kind of previous intervention
All patients will be rehabilitated with new complete dentures in the study

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
30 days after randomization; and 30 days after final prosthetic rehabilitation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
The extent of mandibular movement will be assessed by intramural record of Gothic Gysi arch.
30 days after randomization; and 30 days after the final prosthetic rehabilitation

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
The condyle-fossa relation will be measured by cone-bean computed tomographic scan.
30 days after randomization; and 30 days after the final prosthetic rehabilitation

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

13. september 2013

Først indsendt, der opfyldte QC-kriterier

13. december 2013

Først opslået (Skøn)

19. december 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2017

Sidst verificeret

1. april 2017

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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