Completed

NCT Number: NCT02482064

Using Flexible Resin in Maxillary Obturators

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.

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Key information

Conditions

Patients Who Had Undergone Partial or Complete Maxillectomy

Age range

10 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Removable Prosthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flexible resin

Other

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

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jun 25, 2015
Registry last updated: Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.