Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques

Complete Denture Tooth Movement in Digital Light Processing Versus Conventional Fabrication Techniques: A Randomized Controlled Trial

The purposes of this study are to compare the denture tooth movement, the amount of occlusal adjustment needed and the chairside time required for CAD-CAM and conventional dentures.

PICOT Format:

P: completely edentulous patients. I: Complete denture fabricated by digital light processing method. C: Complete denture fabricated by the conventional method.

O:

Primary Outcome: Denture tooth movement

Secondary outcomes:

• Amount of occlusal adjustments needed
• Chairside time T: Three months with a wash-up period of 2 weeks

Study Overview

• Status: Unknown
• Conditions: Rapid Prototyping in Dentures
• Intervention / Treatment: Other: Complete Denture; Other: Rapid prototyped denture

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaymaa M Belety; Phone Number: +201224101002; Email: sbelety@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ranging from 40-70 years.
• Cooperative patients with no history of psychological diseases.
• Completely edentulous patients with types I, II and III mandibles according to McGarry et al.

Exclusion Criteria:

• Pathological changes of residual ridges
• Patients with xerostomia.
• Patients with flabby ridges.
• Temporomandibular disorders and neuromuscular disorders e.g. Parkinson's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Conventional CD; A conventional Complete denture will be constructed and the amount of denture tooth movement will be measured	Other: Complete Denture; A conventional CD will be constructed
ACTIVE_COMPARATOR: Rapid Prototyped Denture; A digital light processed denture will be constructed and the amount of tooth movement will be measured	Other: Rapid prototyped denture; A 3d printed complete denture will be constructed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of tooth movement	The amount of tooth movement will be measured immediately after denture construction using the Geomagic surface matching software (Geomagic Control 2014; 3D Systems Inc.) Laser scan images of the denture obtained both after trial setup of teeth and of the final denture after being hydrated for 24 hours. Those images will be transferred into STL files that will then be superimposed using the global registration function of the software by finding 10,000 points in common between both pre and pot processing STL files. Measurements will be made at different points using the software and colour surface maps will be created using the 3D comparison function to display the amount and direction of tooth movement	8 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Iman A Radi, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): October 30, 2021

Study Registration Dates

• First Submitted: July 17, 2019
• First Submitted That Met QC Criteria: July 17, 2019
• First Posted (ACTUAL): July 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Rapid Prototyping Dentures

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No