Intelligibility and Acoustic Speech Performance of CAD/CAM Milled Titanium Partial Dentures

NCT06589570 | Recruiting

• 1 other identifier: 2024-3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Partial dentures play a crucial role in restoring oral function and aesthetics for patients with missing teeth. Traditionally, these prostheses have been fabricated using materials such as acrylic resin or cobalt-chromium alloys. However, advancements in digital dentistry have introduced new materials and manufacturing techniques, including computer-aided design and computer-aided manufacturing (CAD/CAM) milled titanium. While titanium offers advantages such as biocompatibility, lightweight properties, and corrosion resistance, its impact on speech performance remains understudied.

Conditions

Speech; Denture, Partial, Removable; CAD-CAM

Outcome Measures

Primary Outcomes (1)

• Speech analysis

  Speech analysis refers to the systematic study and evaluation of human speech to understand various characteristics and functions related to sound production, articulation, and language. It is used in a wide range of fields, from linguistics and phonetics to medical and technological applications, such as diagnosing speech disorders and developing voice recognition systems.

  after 1 and 3 months

Secondary Outcomes (1)

• Intelligibility test

  after 1 and 3 months

Study Arms (2)

Conventional impression-based fabrication of cobalt-chromium framework

ACTIVE COMPARATOR

The conventional impression-based fabrication of a cobalt-chromium framework for partial dentures follows a well-established process that involves multiple steps to ensure an accurate and functional prosthesis. This method, which has been widely used for decades, relies on manual techniques and skilled craftsmanship to create the metal framework that supports the artificial teeth and secures the denture in place.

Device: Removable Partial Denture

CAD design, and CAM milling of titanium framework

EXPERIMENTAL

The CAD (Computer-Aided Design) and CAM (Computer-Aided Manufacturing) process for creating a titanium framework for partial dentures represents a modern, highly precise approach to dental prosthesis fabrication. This digital process offers several advantages over traditional methods, such as improved accuracy, a more comfortable fit, and a reduction in the number of manual steps involved.

Device: Removable Partial Denture

Interventions

Removable Partial Denture DEVICE

A removable partial denture (RPD) is a dental prosthesis designed to replace one or more missing teeth in the mouth. Unlike full dentures, which are used when all teeth are missing, an RPD is specifically made for patients who still have some of their natural teeth remaining. It restores both function and aesthetics, allowing patients to chew, speak, and smile with greater confidence.

CAD design, and CAM milling of titanium framework; Conventional impression-based fabrication of cobalt-chromium framework

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Class IV Kennedy Classification partial edentulism.
• Sufficient occluso-gingival height of its clinical crown
• Full opposing arch or restored with acceptable restoration
• Edentulous ridge covered by healthy firm muco-periosteum
• The abutment teeth had apparently good periodontal condition
• Adequate inter-arch space
• All patients were apparently in good general health
• Only patients who can be easily motivated to achieve and maintain good oral hygiene were selected

You may not qualify if:

• without abnormal bony irregularity or sever lingual undercut
• with no signs of mobility or inflammation with no tissue undercut
• Patients with shallow floor of the mouth, prominent lingual tori, bony undercuts and lingual inclined teeth were all excluded
• no tempro-mandibular joint disorders
• free from systemic diseases as diabetes mellitus

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

NRC

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Speech

Interventions

Denture, Partial, Removable

Condition Hierarchy (Ancestors)

Verbal Behavior; Communication; Behavior

Intervention Hierarchy (Ancestors)

Denture, Partial; Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

Shady Elnaggar, PHD

CONTACT

+201122110085; shady.elnaggar.85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 9, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)