Using Flexible Resin in Maxillary Obturators

NCT ID: NCT02482064

Last Updated: 2016-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Patients Who Had Undergone Partial or Complete Maxillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Traditional Obturators

Patients will use traditional obturators which are going to be made from ordinary heat-activated acrylic resin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Flexible Obturators

Patients will use the new obturators made from flexible resin.

Group Type EXPERIMENTAL

Flexible resin

Intervention Type OTHER

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

Interventions

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Flexible resin

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huda Yahia, DDS

Role: PRINCIPAL_INVESTIGATOR

MSc student, Removable Prosthodontic Department, University of Damascus Dental School

Eyad Al-Shaarani, DDS MSc PhD

Role: STUDY_DIRECTOR

Professor of Removable Prosthodontics, University of Damascus Dental School

Locations

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Department of Removable Prosthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 11753303 (View on PubMed)

Grossmann 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.

Reference Type BACKGROUND
PMID: 16126082 (View on PubMed)

MacCarthy 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.

Reference Type BACKGROUND
PMID: 10842133 (View on PubMed)

Kanazawa 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.

Reference Type BACKGROUND
PMID: 11012850 (View on PubMed)

Other Identifiers

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UDDS-RemPro-01-2015

Identifier Type: -

Identifier Source: org_study_id

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