Using Flexible Resin in Maxillary Obturators

N/ACompletedNCT02482064

Damascus University10 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Patients Who Had Undergone Partial or Complete Maxillectomy

Interventions

Flexible resinOTHER

This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Removable Prosthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 minutes following appliance insertion in the mouth

Data from ClinicalTrials.gov

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