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

Complete Denture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03354715
• Other study ID #: 2717
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Denture

Intervention

Device:
• 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.
• Heat Cured Conventional Complete Denture
it is the main treatment for most of completely edentoulous Cases

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	CAiro

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Satisfaction	Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other	3 month
Secondary	Retention	resistance to tissue away movement using digital force meter and recording the average of 10 reading in one time and compare the results of the two denture	3 month