Patients Who Had Undergone Partial or Complete MaxillectomyNCT02482064
Using Flexible Resin in Maxillary Obturators
A study testing Flexible resin in people with Patients Who Had Undergone Partial or Complete Maxillectomy, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Patients Who Had Undergone Partial or Complete Maxillectomy
- What is being tested?
- Flexible resin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSyria
- Study dates
- May 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Removable Prosthodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
Official title: A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
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.
Read the 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.
- Being tested
- Flexible resin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible resinOther
This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Obturators | No intervention | Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin. |
| Flexible Obturators | Experimental | Patients will use the new obturators made from flexible resin. Receives: Other: Flexible resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes following appliance insertion in the mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Patients Who Had Undergone Partial or Complete MaxillectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huda Yahia, DDS, Principal investigator, MSc student, Removable Prosthodontic Department, University of Damascus Dental SchoolEyad Al-Shaarani, DDS MSc PhD, Study director, Professor of Removable Prosthodontics, University of Damascus Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482064
- Sponsor's protocol ID
- UDDS-RemPro-01-2015
- Status last verified
- Jun 2016
- First submitted
- 23 Jun 2015
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11753303Grossmann 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.
PubMed 16126082MacCarthy 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.
PubMed 10842133Kanazawa 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.
PubMed 11012850
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Comparative Study of Two Types of Maxillary Obturators Made of Heat Cure Acrylic Resin or Flexible Resin
- ClinicalTrials.gov ID
- NCT02482064
- Acronym / sponsor ID
- UDDS-RemPro-01-2015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Obturators | No intervention | –Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin. |
| Flexible Obturators | Experimental | Other: Flexible resinPatients will use the new obturators made from flexible resin. |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible resinThis material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'. | Other | Flexible Obturators |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Background: PubMed 11753303Aramany 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.
- Background: PubMed 16126082Grossmann 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.
- Background: PubMed 10842133MacCarthy 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.
- Background: PubMed 11012850Kanazawa 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huda Yahia, DDS principal investigator
MSc student, Removable Prosthodontic Department, University of Damascus Dental School
Eyad Al-Shaarani, DDS MSc PhD study director
Professor of Removable Prosthodontics, University of Damascus Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible resin in people with Patients Who Had Undergone Partial or Complete Maxillectomy, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of leaking water drops from the nose (time frame: 30 minutes following appliance insertion in the mouth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02482064, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.