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

Edentulous Mouth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05834530
• Other study ID #: REC-PD-22-21
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: April 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Mouth
• Mouth, Edentulous

Intervention

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.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, AlAzhar University for Girls	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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