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

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

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.

Study Overview

• Status: Unknown
• Conditions: Complete Denture
• Intervention / Treatment: Device: Rapid prototyping Denture base; Device: Heat Cured Conventional Complete Denture

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • CAiro, Egypt, 111789
    • Recruiting
    • Faculty of Dentistry
    • Contact: Atef AS Shaker, dr; Phone Number: 23634965; Email: atefshaker@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Rapid prototyping Denture base; Complete Denture Using Rapid Prototyping method for fabrication of the complete denture depending on	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.
Sham Comparator: Heat Cured Conventional Complete Denture; Complete Denture using heat cured Denture base using flasking and deflasking method	Device: Heat Cured Conventional Complete Denture; it is the main treatment for most of completely edentoulous Cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient Satisfaction Questionnaire using likert scale five points represent degree of satisfaction and compare the result to each other	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 12, 2018
• Last Update Submitted That Met QC Criteria: June 11, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2717

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No