Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02482064
Enrollment
10
Registered
2015-06-25
Start date
2015-05-31
Completion date
2016-05-31
Last updated
2016-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Who Had Undergone Partial or Complete Maxillectomy

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.

Interventions

OTHERFlexible resin

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
10 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Amount of leaking water drops from the nose30 minutes following appliance insertion in the mouthEach 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 speech30 minutes following appliance insertion in the mouthEach 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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026