- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02482064
Using Flexible Resin in Maxillary Obturators
A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
Ten patients who had had maxillectomy will be assigned to two groups employing two types of 'temporary obturators. The obturators in the first group will be made from heat cure acrylic resin, whereas those in the second group from flexible resin.
A comparison will be made between the two materials in terms of oral-nasal seal using the drinking water test as well as the mirror test.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Damascus, Syrien Arabiske Republik, DM20AM18
- Department of removable prosthodontics, University of Damascus Dental School
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- patient who had partial or complete maxillectomy
- two weeks should have passed at least before being included in the study.
- patient should have completed their radiotherapy.
Exclusion Criteria:
- patients under the age of 10 years
- patients who had had their operations more than five months before the being recruited.
- patients who are under radiotherapy when asked to participate in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Traditional Obturators
Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.
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Eksperimentel: Flexible Obturators
Patients will use the new obturators made from flexible resin.
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This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Amount of leaking water drops from the nose
Tidsramme: 30 minutes following appliance insertion in the mouth
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Each patient is asked to drink an amount of water and keep a specific amount of water in the mouth for two to three minutes.
He/she is asked to rotate his/her head 20-30 degrees downward and forward.
During this period the amount of leaking water drops from the nose is collected and weighted.
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30 minutes following appliance insertion in the mouth
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Amount of air flow through the nose during speech
Tidsramme: 30 minutes following appliance insertion in the mouth
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Each patient is asked to utter the following letters: K, T, D. A cold small mirror is placed in front of the nose during the utterance of these consonants.
If a fogginess is observed on the mirror, this means that there is an oral-nasal leakage of air.
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30 minutes following appliance insertion in the mouth
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Huda Yahia, DDS, MSc student, Removable Prosthodontic Department, University of Damascus Dental School
- Studieleder: Eyad Al-Shaarani, DDS MSc PhD, Professor of Removable Prosthodontics, University of Damascus Dental School
Publikationer og nyttige links
Generelle publikationer
- Aramany MA. Basic principles of obturator design for partially edentulous patients. Part II: Design principles. 1978 [classical article]. J Prosthet Dent. 2001 Dec;86(6):562-8. doi: 10.1067/mpr.2001.121619. No abstract available.
- Grossmann Y, Savion I. The use of a light-polymerized resin-based obturator for the treatment of the maxillofacial patient. J Prosthet Dent. 2005 Sep;94(3):289-92. doi: 10.1016/j.prosdent.2005.06.014.
- MacCarthy D, Murphy N. Replacement of an obturator section of an existing two-piece implant-retained edentulous obturator. J Prosthet Dent. 2000 Jun;83(6):652-5.
- Kanazawa T, Yoshida H, Furuya Y, Shimodaira K. Sectional prosthesis with hollow obturator portion made of thin silicone layer over resin frame. J Oral Rehabil. 2000 Sep;27(9):760-4. doi: 10.1046/j.1365-2842.2000.00584.x.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UDDS-RemPro-01-2015
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