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

NCT ID: NCT06589570

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-12-06

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.

Detailed Description

While the benefits of titanium in terms of durability, comfort, and biocompatibility are well-established, its impact on speech performance remains a relatively understudied aspect of its use in partial dentures. Speech is a complex function that involves the coordination of the teeth, tongue, lips, and other oral structures. The introduction of any foreign object, such as a denture, into the mouth has the potential to affect the way sounds are produced and articulated, which is why the impact of denture materials on speech must be carefully considered.

Traditional denture materials, such as acrylic resin and cobalt-chromium alloys, have been extensively studied in terms of their effects on speech performance. Research has shown that the thickness, weight, and positioning of dentures can influence how well patients are able to articulate certain sounds, particularly sibilants (such as "s" and "z" sounds) and fricatives (such as "f" and "v" sounds). Thicker or poorly fitted dentures can interfere with the movement of the tongue and lips, leading to speech distortions or difficulties in pronunciation.

Given that titanium is lighter and thinner than many traditional materials, it is reasonable to hypothesize that it could offer advantages in terms of speech performance. The reduced weight of titanium partial dentures may allow for more natural tongue and lip movements, potentially resulting in clearer and more accurate speech. Additionally, the precision of CAD/CAM technology allows for the creation of dentures that fit more snugly and comfortably in the mouth, further reducing the likelihood of speech impediments.

However, despite these potential benefits, there is currently limited research specifically focused on the impact of titanium partial dentures on speech performance. Most studies on the material have concentrated on its mechanical properties, such as strength, durability, and biocompatibility, while its effects on speech have received less attention. As speech is a vital function for communication and quality of life, further research is needed to determine whether titanium dentures offer significant improvements over traditional materials in this regard.

Conditions

Speech; Denture, Partial, Removable; CAD-CAM

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Conventional impression-based fabrication of cobalt-chromium framework

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.

Group Type: ACTIVE_COMPARATOR

Removable Partial Denture

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Removable Partial Denture

Intervention Type: 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.

Interventions

Removable Partial Denture

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

Shady El Naggar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NRC

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Shady Elnaggar, PHD

Role: CONTACT

shady.elnaggar.85@gmail.com

+201122110085

Facility Contacts

Sherihan Eissa, PHD

Role: primary

dr_sherihan_1986@yahoo.com

+201154777474

Other Identifiers

2024-3

Identifier Type: -

Identifier Source: org_study_id