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Clinical Trials/NCT05834530
NCT05834530CompletedNot Applicable

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

Al-Azhar University1 site in 1 country10 target enrollmentStarted: December 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Change of Retention

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
50 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shereen Kabeel

Associate Professor

Al-Azhar University

Study Sites (1)

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