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RecruitingNCT06589570Updated Sep 3, 2025

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

An interventional study of Removable Partial Denture in Speech, Denture, Partial, Removable and CAD-CAM, sponsored by Badr University. Recruiting at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Badr University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Speech
  • Denture, Partial, Removable
  • CAD-CAM

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03

In context

Speech

205 studies on the registry are indexed under Speech; 80 are open to participants now.

This study's planned enrollment of 12 is below the median of 52 across 141 interventional studies indexed under Speech.

Browse Speech studies →

Lead sponsor

Badr University is the lead sponsor of 64 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Active comparator
    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.

    Device: Removable Partial Denture

  • Experimental
    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.

    Device: Removable Partial Denture

Interventions

  • DeviceRemovable 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.

06

What researchers measure

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.

    Time frame: after 1 and 3 months

Secondary outcomes

  1. Intelligibility test

    An intelligibility test of speech is a method used to assess how well a person's speech is understood by others. It measures the clarity, precision, and comprehensibility of spoken words, focusing on how accurately listeners can interpret the speech without needing context or prior knowledge of the speaker\'s intent. Intelligibility tests are particularly important in diagnosing and evaluating speech disorders, assessing the effectiveness of speech treatments, and analyzing the impact of devices like dentures or hearing aids on communication.

    Time frame: after 1 and 3 months

07

Study locations

1 of 1 sites recruiting
  • NRC
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2024 to primary completion in Dec 2024, 2 months.

Of 85 non-industry interventional studies with no phase under Speech, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 65. This study's 2 months is below that.

Counting every sponsor, half of 90 studies reached it within 45 months; a quarter within 15 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2024
First posted
Sep 19, 2024
StartActual
Sep 9, 2024
Primary completionActual
Dec 6, 2024
CompletionEst.
Dec 6, 2025
Last update
Sep 3, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06589570
Lead sponsor
Badr University
Responsible party
Shady El Naggar (Principal Investigator, Badr University) — Principal investigator
First posted
Sep 19, 2024
Start date
Sep 9, 2024
Primary completion
Dec 6, 2024
Completion
Dec 6, 2025 (estimated)
Last update
Sep 3, 2025

Study contacts

Shady Elnaggar, PHD
Contact
shady.elnaggar.85@gmail.com
+201122110085

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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