NCT05834530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

January 22, 2023

Last Update Submit

April 27, 2023

Conditions

Edentulous Mouth

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Accuracy

    up to 1 week

  • Electromyography Change

    3 months

  • Change of Patient satisfaction

    3 months

Study Arms (2)

Conventional Complete Denture

NO INTERVENTION

3 D printed Complete Denture

EXPERIMENTAL
Other: 3D Printed Complete Dentures

Interventions

3D Printed Complete DenturesOTHER

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.

3 D printed Complete Denture

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, AlAzhar University for Girls

Cairo, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2023

First Posted

April 28, 2023

Study Start

December 1, 2021

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

EG(1)