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Using Flexible Resin in Maxillary Obturators

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ClinicalTrials.gov Identifier: NCT02482064
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Damascus University

Brief Summary:

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

Detailed Description:
Oral rehabilitation following partial maxillectomy presents numerous clinical and technical issues. Using soft-tissue undercuts in the palatal side of the upper jaw is so useful for prostheses' retention over and above the abutment teeth. The use of flexible materials can serve this aim. The current study aims to compare the efficacy of nasal-oral seal using flexible materials against the traditional method of using heat activated acrylic materials.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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'.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   10 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Syrian Arab Republic
Department of Removable Prosthodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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