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OpenTrials
Completed

NCT Number: NCT05834530

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

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

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, AlAzhar University for Girls

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Printed Complete Dentures

Other

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 outcomes

  1. Change of Retention

    Time frame: 3 months

    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.

Other outcomes

  1. Accuracy

    Time frame: up to 1 week

    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.

  2. Electromyography Change

    Time frame: 3 months

    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. Change of Patient satisfaction

    Time frame: 3 months

    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).

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2023
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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