Using Flexible Resin in Maxillary Obturators
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02482064|
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients Who Had Undergone Partial or Complete Maxillectomy||Other: Flexible resin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||May 2016|
No Intervention: Traditional Obturators
Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.
Experimental: Flexible Obturators
Patients will use the new obturators made from flexible resin.
Other: Flexible resin
This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
- Amount of leaking water drops from the nose [ Time Frame: 30 minutes following appliance insertion in the mouth ]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.
- Amount of air flow through the nose during speech [ Time Frame: 30 minutes following appliance insertion in the mouth ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482064
|Syrian Arab Republic|
|Department of Removable Prosthodontics, University of Damascus Dental School|
|Damascus, Syrian Arab Republic, DM20AM18|
|Principal Investigator:||Huda Yahia, DDS||MSc student, Removable Prosthodontic Department, University of Damascus Dental School|
|Study Director:||Eyad Al-Shaarani, DDS MSc PhD||Professor of Removable Prosthodontics, University of Damascus Dental School|