- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Damascus, République arabe syrienne, DM20AM18
- Department of removable prosthodontics, University of Damascus Dental School
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Traditional Obturators
Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Amount of leaking water drops from the nose
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Huda Yahia, DDS, MSc student, Removable Prosthodontic Department, University of Damascus Dental School
- Directeur d'études: Eyad Al-Shaarani, DDS MSc PhD, Professor of Removable Prosthodontics, University of Damascus Dental School
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- UDDS-RemPro-01-2015
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