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.

Study Overview

• Status: Completed
• Conditions: Patients Who Had Undergone Partial or Complete Maxillectomy
• Intervention / Treatment: Other: Flexible resin

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Damascus, Syrian Arab Republic, DM20AM18
    • Department of removable prosthodontics, University of Damascus Dental School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of leaking water drops from the nose	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.	30 minutes following appliance insertion in the mouth
Amount of air flow through the nose during speech	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.	30 minutes following appliance insertion in the mouth

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: June 23, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Estimate): June 10, 2016
• Last Update Submitted That Met QC Criteria: June 8, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: UDDS-RemPro-01-2015