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

NCT04025697 | Unknown DMC

• 1 other identifier: Rapid Prototyping Dentures
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rapid Prototyping in Dentures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Conventional CD

PLACEBO COMPARATOR

A conventional Complete denture will be constructed and the amount of denture tooth movement will be measured

Other: Complete Denture

Rapid Prototyped Denture

ACTIVE COMPARATOR

A digital light processed denture will be constructed and the amount of tooth movement will be measured

Other: Rapid prototyped denture

Interventions

Complete Denture OTHER

A conventional CD will be constructed

Conventional CD

Rapid prototyped denture OTHER

A 3d printed complete denture will be constructed

Rapid Prototyped Denture

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Iman A Radi

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Shaymaa M Belety

CONTACT

+201224101002; sbelety@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: October 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: October 30, 2021
• Last Updated: July 22, 2019

Record last verified: 2019-07