A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damascus University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Amount of leaking water drops from the nose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 10 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Traditional Obturators
Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.
Flexible Obturators
Patients will use the new obturators made from flexible resin.
Intervention: Flexible resin (Other)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported