Patient Satisfaction and Retention of Upper Complete Denture Base Using Rapid Prototyping Versus a Conventional One

NCT ID: NCT03354715

Last Updated: 2018-06-12

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-12-01

Brief Summary

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Comparing patient satisfaction and retention of upper complete denture fabricated using two different denture base materials, the first fabricated using rapid prototyping method while the second is following conventional methods.

Detailed Description

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Searching for other materials or other fabrication technologies has been one of the goals to help to re-innovate the fabrication of complete dentures , which would greatly influence completely edentulous Patient satisfaction. The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

SLA has been used in dental fields like maxillofacial prosthesis , wax pattern fabrication for crown bridge , removable partial denture 19, but still complete denture was reported in a very few reports indicating that RP is not yet successfully applied in Complete denture manufacturing 19-21A randomised trial is therefore needed to asses accurately wether the introduction of rapid prototyping in complete denture fabrication is successful or not in comparison to the conventional technique and to discover the possible challenges in this recent technique and the ways to overcome it.

Retention of complete dentures and patient satisfaction has been reported in many studies22-26. Patients have showed a higher satisfaction, as retention of both maxillary and mandibular complete dentures increased.

Conditions

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Complete Denture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rapid prototyping Denture base

Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on

Group Type SHAM_COMPARATOR

Rapid prototyping Denture base

Intervention Type DEVICE

The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

Heat Cured Conventional Complete Denture

Complete Denture using heat cured Denture base using flasking and deflasking method

Group Type SHAM_COMPARATOR

Heat Cured Conventional Complete Denture

Intervention Type DEVICE

it is the main treatment for most of completely edentoulous Cases

Interventions

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Rapid prototyping Denture base

The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.

Intervention Type DEVICE

Heat Cured Conventional Complete Denture

it is the main treatment for most of completely edentoulous Cases

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age ranging from 40-70 years.
2. Patients who can understand and respond to a written questionnaire in Arabic.
3. Cooperative patients

Exclusion Criteria

1. Pathological changes of residual ridges.
2. Patients with debilitating systemic diseases.
3. Patients with xerostomia.
4. Patients with flabby and flat ridges.
5. Patients with allergy to acrylic resin
6. Patient with sever undercuts, or irregular bony exostosis
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omar Mahmoud Youssef

Master Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Atef AS Shaker, dr

Role: primary

Other Identifiers

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2717

Identifier Type: -

Identifier Source: org_study_id

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