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Oral Food Processing for Digitally Constructed Complete Dentures Versus Conventional Complete Dentures.

NCT07290933 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-18

No results posted yet for this study

Summary

The study aimed to compare the effects of fully digital versus conventional complete denture fabrication on oral food processing (mastication and swallowing of solids) in edentulous patients, using the Test of Mastication and Swallowing Solids (TOMASS).

In a randomized crossover study design was carried out on 14 completely edentulous participants (age 50-65 years, both sexes) in good general and oral health, each participants received two sets of dentures: one fabricated with conventional workflow (physical impressions, tooth arrangement, processing into heat polymerized acrylic) and one fully digital workflow (Intra-oral scanning , CAD/CAM design, 3D printed base and teeth,). Each denture was worn for 3 months; with a 2 week "wash out" period between wearing periods, during which participants reverted to their old dentures or no dentures. The order (Conventional complete denture first vs Digital complete denture first) was randomized. At the end of each denture period, Oral food processing performance was measured using TOMASS (solid cracker test): Swallowing threshold and TOMASS test parameters that include number of bites, number of masticatory cycles, number of swallows, and total time (from first bite to last swallow)

Conditions

  • Swallowing Disorder

Interventions

PROCEDURE

Procedure for construction of complete denture either conventional or fully digital fabrication

To ensure consistency and minimize patient visits, fabrication of both the conventional and fully digital complete dentures was conducted simultaneously during each clinical stage. All procedures were performed by the same prosthodontist, and efforts were made to standardize materials, occlusal schemes, and vertical dimension across both workflows for each patient. each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed E Elgamal · Mansoura University

  • Abdallah M Ibrahim · Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Max Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-17
Primary Completion
2025-10-06
Completion
2025-12-02

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290933 on ClinicalTrials.gov