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

Primary Purpose

Edentulous Mouth

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D Printed Complete Dentures
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Mouth

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Dentistry, AlAzhar University for Girls

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Complete Denture

3 D printed Complete Denture

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2023
Last Updated
April 27, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05834530
Brief Title
Comparison of Conventional Versus 3-D Printed Complete Denture Regarding Retention, Accuracy, Elctromyographic Activity and Patient Satisfaction.
Official Title
Electromyographic Activity, Accuracy, Patient Satisfaction and Retention of Conventional Versus 3-D Printed Maxillary Complete Denture: A Cross-over Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Complete Denture
Arm Type
No Intervention
Arm Title
3 D printed Complete Denture
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
3D Printed Complete Dentures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Retention
Description
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.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Accuracy
Description
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.
Time Frame
up to 1 week
Title
Electromyography Change
Description
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
Time Frame
3 months
Title
Change of Patient satisfaction
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Dentistry, AlAzhar University for Girls
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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