Clinical trial NCT02482064: Using Flexible Resin in Maxillary Obturators
Official title: A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Who Had Undergone Partial or Complete Maxillectomy
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 10
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Amount of leaking water drops from the nose
timeFrame: 30 minutes following appliance insertion in the mouth
measure: Amount of air flow through the nose during speech
timeFrame: 30 minutes following appliance insertion in the mouth
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Removable Prosthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student, Removable Prosthodontic Department, University of Damascus Dental School
name: Huda Yahia, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Removable Prosthodontics, University of Damascus Dental School
name: Eyad Al-Shaarani, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.