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

NCT07290933 | Completed

• 1 other identifier: R.25.11.82
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

complete denture; Fully digital; Food processing

Outcome Measures

Primary Outcomes (2)

• Swallowing threshold

  Swallowing threshold, which is the duration of chewing until the first swallow (determined by the moment of laryngeal elevation)

  3 months after denture use

• The TOMASS test parameters: Number of bites:

  Number of bites: The number of discrete bites taken to finish the cracker

  3 months after denture use

Secondary Outcomes (3)

• Number of masticatory cycles:

  3 months after denture use

• Number of swallows

  3 months after denture use

• Total ingestion time:

  3 months after denture use

Study Arms (2)

Conventionally fabricated complete denture

ACTIVE COMPARATOR

Each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique. The participants received conventional Complete dentures. Three months after denture use, the TOMASS test was done.

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

Fully digital fabricated complete denture

ACTIVE COMPARATOR

Each patient received two sets of dentures fabricated to identical functional and esthetic specifications, differing only in the manufacturing technique. The participants received Fully digital fabricated complete denture. Three months after denture use, the TOMASS test was done.

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

Interventions

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

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.

Conventionally fabricated complete denture; Fully digital fabricated complete denture

Eligibility Criteria

• Age: 50 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants with temporo-mandibular joint disorders.
• head/neck injury, or with skeletal deformity.
• Inability to wear dentures for extended periods or intolerance to the study

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Removable prosthodontics department,Faculty of dentistry,Mansoura university, #68 ElGomhoria Street, ElMansoura, Egypt. Mansoura, Eldakahlia, Egypt, 35516

Al Mansurah, Eldakahlia,, 35516, Egypt

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mohamed E Elgamal

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Abdallah M Ibrahim

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Prosthodontics

Model Details: This randomized crossover clinical trial evaluated swallowing function using the TOMASS test in patients fitted with 2 types of complete dentures (CDs): Conventionally fabricated CDS and Fully Digital fabricated CDs. Randomization process to participants was done to minimize the impact of the order of denture type on the measurements of swallowing threshold and Oral food processing assessment.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 18, 2025
• Study Start: November 17, 2024
• Primary Completion: October 6, 2025
• Study Completion: December 2, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)