Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.

Electromyographic Activity, Accuracy, Patient Satisfaction and Retention of Conventional Versus 3-D Printed Maxillary Complete Denture: A Cross-over Randomized Controlled Trial

Analyzing and comparing the retention, accuracy, EMG and patient satisfaction of maxillary complete denture base fabricated by conventional and rapid prototyping techniques.

Study Overview

• Status: Completed
• Conditions: Edentulous Mouth
• Intervention / Treatment: Other: 3D Printed Complete Dentures

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, AlAzhar University for Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Elligibility Criteria:

Inclusion Criteria:

• Completely edentulous patients were selected to have their ridges covered with firm, thick and compressible mucosa
• All patients accepting prosthodontic treatment by an removable denture.

Exclusion Criteria:

• TMJ disorder.
• Limited mouth opening or mandibular movement
• Muscle spasm or tenderness
• Mandibular deviation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Complete Denture
Experimental: 3 D printed Complete Denture	Other: 3D Printed Complete Dentures; Denture bases printed from a pre-polymerized block via additive technique, using photon S desktop 3D printer* that relies on SLA technology and post cured by post curing unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Retention	Retention was measured for both groups using the universal testing machine. Modification in each denture was made where two small metal tubes (3 mm diameters) were placed a few millimeters above the laterals in maxillary dentures by self-cure acrylic resin. The distance between the right tube and the geometric center was almost the same distance as between the left tube and the geometric center. The exact distance was checked using an orthodontic wire.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	The fitting surfaces of each upper denture was sprayed and scanned after finishing and before delivery, then was saved as an STL file after flipping of the denture's fitting surface to resemble the cast surface. Geomagic software was used to evaluate the accuracy at which the master cast STL file was selected as a reference data and the STL file of the flipped fitting surface of the denture was selected as a measured data. Both files were automatically aligned together by selecting the "best fit alignment "icon. The accuracy of the denture bases generated in a color map according to the 3D deviation between the denture base and reference data. Blue color indicates negative deviation (tissue compression), yellow to red color indicates positive deviation (misfit with space) while green color indicates measured deviation below 0.2mm.	up to 1 week
Electromyography Change	The electromyographic activity was recorded for each patient by Nemus 2 machine. Washing period of 2 weeks between each denture as the same in masticatory efficiency and recorded as follow: The electromyographic activity was performed by measuring muscle activity of the masseter muscle on both sides	3 months
Change of Patient satisfaction	Patient satisfaction was investigated through a questionnaire, which was given to the patients. Evaluation of patient satisfaction was measured using the visual analogue scale (VAS) in which patients scored their answers using a scale from 0 to 10 cm (low/worst to high/best).	3 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: January 22, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: REC-PD-22-21

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