SpeechNCT06589570
Intelligibility and Acoustic Speech Performance of CAD/CAM Milled Titanium Partial Dentures
A study testing Removable Partial Denture in people with Speech and Denture, Partial, Removable, run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Speech, Denture, Partial, Removable, CAD-CAM
- What is being tested?
- Removable Partial Denture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2024to 6 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
NRC
Cairo
Sherihan Eissa, PHD, +201154777474, dr_sherihan_1986@yahoo.com
About this study
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.
- Conditions
- Speech, Denture, Partial, Removable, CAD-CAM
- Being tested
- Removable Partial Denture
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removable Partial DentureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Removable Partial Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: after 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Sep 2024
- Primary completion6 Dec 2024
- Study completion6 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady El Naggar, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589570
- Sponsor's protocol ID
- 2024-3
- Status last verified
- Sep 2025
- First submitted
- 6 Sep 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligibility and Acoustic Speech Performance of CAD/CAM Milled Titanium Partial Dentures
- ClinicalTrials.gov ID
- NCT06589570
- Acronym / sponsor ID
- 2024-3
- Conditions
- Speech, Denture, Partial, Removable, CAD-CAM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional impression-based fabrication of cobalt-chromium framework | Active comparator | Device: Removable Partial DentureThe 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. |
| CAD design, and CAM milling of titanium framework | Experimental | Device: Removable Partial DentureThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removable Partial DentureA 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. | Device | CAD design, and CAM milling of titanium framework, Conventional impression-based fabrication of cobalt-chromium framework |
Primary outcome
Speech analysis
Time frame: after 1 and 3 months
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.
1 secondary outcome
Intelligibility test
Time frame: after 1 and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Removable Partial Denture in people with Speech and Denture, Partial, Removable, run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shady Elnaggar, PHD (+201122110085, shady.elnaggar.85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech analysis (time frame: after 1 and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.