MalocclusionNCT07331090
Evaluation of Removable Appliances and Clear Aligners in Early Orthodontic Treatments During the Mixed Dentition Period
An observational study of Malocclusion and Crossbite, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Malocclusion, Crossbite
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 May 2025
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consisted of systemically healthy children aged 6-12 years who presented to the Clinics of the Departments of Pediatric Dentistry and Orthodontics at Marmara University Faculty of Dentistry with an initial need for orthodontic treatment.
Who may be able to join
- Children aged between 6 and 12 years who applied to the Clinics of the Departments of Pedodontics and Orthodontics at Marmara University Faculty of Dentistry were included in the study.
- Patients were required to present with anterior cross-bite type malocclusion.
- Participants had to be cooperative, native Turkish speakers, and have no systemic disease, syndrome, craniofacial anomaly, or known allergy.
- Individuals with no apparent oro-facial anomaly, no hearing or speech impairment, and no reading or language difficulties were included.
- Based on clinical and radiographic evaluations, only patients whose malocclusions were determined to be dental in origin (not skeletal) were selected.
- Patients who did not require maxillary (palatal) expansion were also included in the study.
Who cannot join
- The study excluded patients who had severe periodontal disease, a history of systemic illness, a known allergy to any of the materials used in the study, poor oral hygiene, insufficient cooperation, or who did not agree to attend regular follow-up appointments during the study period.
- Additionally, individuals with craniofacial anomalies or skeletal-origin malocclusions were not included. Participants with hearing impairments, non-native Turkish speakers, or those with any disease or history of surgery that could affect voice or speech quality were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Universty School of Dentistry
Istanbul, Maltepe, 34854
About this study
Official title: A Comparative Evaluation of Removable Appliances and Clear Aligners in Terms of Multidimensional Parameters and Their Effects on Phonation in Early Orthodontic Treatments During the Mixed Dentition Period
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
Read the detailed description
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
The mixed dentition period, occurring approximately between the ages of 6 and 12, represents a transitional developmental stage during which primary and permanent teeth coexist. In this phase, early diagnosis and treatment of orthodontic anomalies are particularly important to support functional, aesthetic, and psychosocial development and to minimize the need for more complex treatment in later stages.
Removable orthodontic appliances have traditionally been used to guide dental arch development, correct minor malocclusions, and eliminate harmful oral habits. Advances in digital technology have introduced clear aligners as an alternative treatment option that offers aesthetic and removable features. Despite their differences in design and material characteristics, both approaches are commonly used during early orthodontic treatment planning.
Orthodontic appliances may influence various aspects of oral function, including oral hygiene maintenance, periodontal health, caries risk, pain perception, anxiety levels, and speech performance. In growing children, treatment experiences may additionally shape cooperation, adaptation, and overall quality of life. Therefore, evaluating orthodontic interventions during the mixed dentition period requires consideration of not only mechanical efficiency but also broader functional and psychosocial parameters.
Orthodontic treatment need and malocclusion severity may also influence oral hygiene maintenance during treatment. Therefore, the present study additionally evaluates the relationship between orthodontic treatment need assessed using the IOTN and oral hygiene status assessed using the OHI-S at baseline and during the early treatment period. Appliance-related changes in intraoral volume and tongue movement may alter speech production, potentially affecting articulatory patterns and acoustic characteristics. Contemporary acoustic analysis methods, such as the use of specialized speech software, allow the objective measurement of frequency- and time-based acoustic parameters and provide complementary information to clinical observations.
This prospective study was designed to investigate how clear aligners and removable appliances influence oral hygiene status, pain and anxiety perception, oral health-related quality of life, orthodontic treatment need, and speech performance in children. Through standardized clinical assessments, validated questionnaires, and acoustic analysis, the study aims to generate multidimensional data that may guide clinical decision-making in early orthodontic treatment planning.
- Conditions
- Malocclusion, Crossbite
- Keywords
- Removable Orthodontic Appliances, Clear Aligners, Oral Health-Related Quality of Life, Phonation, Anxiety, Visual Analog Scale (VAS), Simplified Oral Hygiene Index (OHI-S), Index of Orthodontic Treatment Need (IOTN)
- Medical subject headings
- Malocclusion, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with clear aligners | Patients aged between 6 and 12 years who required early orthodontic treatment and started clear aligner therapy were included in the study. | |
| Patients treated with removable orthodontic appliances | Patients aged between 6 and 12 years who required early orthodontic treatment and started removable orthodontic appliance therapy were included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Formant frequencies (F1-F4) during speech production
Evaluation of phonation changes during early orthodontic treatment by analysing the first four formant frequencies (F1-F4) obtained from standardized speech recordings. Recordings were collected immediately before appliance placement and on days 1, 3, 7, and 14 after appliance insertion. Words selected from a standardized articulation test were read aloud by the participants, and acoustic data were analysed using Praat software to assess treatment-related variations in vowel resonance patterns.
Units: Hertz (Hz)
Higher values indicate:
Changes in vowel resonance characteristics potentially related to treatment-related alterations in oral cavity configuration.
Measured: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Secondary outcomes (11)
Voice Onset Time (VOT)
Assessment of speech timing by measuring Voice Onset Time (VOT) from standardized speech recordings collected immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing voiceless and voiced stop consonants were read aloud by participants, and VOT values were extracted using Praat software to evaluate treatment-related changes in articulatory timing.
Units: Milliseconds (ms)
Range:
Approximately -100 ms to +150 ms (dependent on consonant type and participant characteristics)
Higher values indicate:
Longer delays between consonant release and onset of voicing, reflecting increased articulatory timing.
Measured: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral Centre of Gravity (CoG)
Assessment of spectral energy distribution during speech production by measuring the spectral Centre of Gravity (CoG) from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and CoG values were extracted using Praat software to evaluate treatment-related changes in spectral balance and resonance characteristics.
Units:Hertz (Hz) Range: Approximately 500-6000 Hz (dependent on sound type and participant characteristics) Higher values indicate: Spectral energy concentrated at higher frequencies, reflecting changes in resonance or articulatory configuration.
Measured: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral skewness
Assessment of spectral shape during speech production by measuring spectral skewness from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and skewness values were extracted using Praat software to evaluate treatment-related changes in the asymmetry of the spectral energy distribution.
Units: Dimensionless (no unit) Range: Approximately -3.0 to +3.0 (dependent on sound type and participant characteristics) Higher values indicate: Greater positive asymmetry of the spectral energy distribution (more energy concentrated above the mean frequency).
Measured: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral kurtosis
Assessment of spectral shape during speech production by measuring spectral kurtosis from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and kurtosis values were extracted using Praat software to evaluate treatment-related changes in the peakedness of the spectral energy distribution.
Units: Dimensionless (no unit) Range: Approximately -1.0 to +10.0 (dependent on sound type and participant characteristics) Higher values indicate: A more peaked spectral energy distribution with relatively more energy concentrated around the mean frequency.
Measured: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Plaque Index (PI; Silness & Löe)
Assessment of dental plaque accumulation recorded at baseline, Day 1, and Day 14.
Units: Score (0-3) Higher values indicate worse plaque accumulation.
Measured: At baseline (before treatment) and 14th days of treatment.
Gingival Index (GI; Löe & Silness)
Evaluation of gingival inflammation recorded at baseline, Day 1, and Day 14. Units: Score (0-3) Higher values indicate worse gingival inflammation.
Measured: At baseline (before treatment) and 14th days of treatment.
Simplified Oral Hygiene Index (OHI-S)
Assessment of oral hygiene status using the Simplified Oral Hygiene Index (OHI-S) recorded at baseline and Day 14 of treatment. Higher scores indicate poorer oral hygiene status.
Measured: At baseline (before treatment) and Day 14 of treatment.
Pain perception (Visual Analog Scale)
Pain perception during early orthodontic treatment will be evaluated using a Visual Analog Scale (VAS). Participants will be asked to rate their pain on a 0-10 scale at multiple time points during adaptation to the appliance, including Days 1, 3, 7, and 14 following appliance insertion.
Units: Scale score (0-10) Range: 0 (no pain) to 10 (severe pain)
Higher values indicate:
Greater perceived pain intensity.
Measured: 1st, 3rd, 7th, and 14th days of treatment
Anxiety levels during treatment (State-Trait Anxiety Inventory for Children)
Anxiety levels during early orthodontic treatment will be evaluated using the State-Trait Anxiety Inventory for Children (STAI-C). Participants will complete the inventory on Days 1, 3, 7, and 14 following appliance insertion to assess treatment-related anxiety at multiple time points.
Units: Scale score (20-60) Range: 20 (low anxiety) to 60 (high anxiety) Higher values indicate: Greater anxiety levels.
Measured: 1st, 3rd, 7th, and 14th days of treatment
Oral health-related quality of life during treatment (OHIP-14)
Oral health-related quality of life during early orthodontic treatment will be evaluated using the Oral Health Impact Profile-14 (OHIP-14). Participants will complete the OHIP-14 questionnaire on Days 1, 3, 7, and 14 following appliance insertion to assess treatment-related changes in patient-reported oral health impact.
Units: Scale score (0-56) Range: 0 (better oral health-related quality of life) to 56 (worse oral health-related quality of life) Higher values indicate: Worse oral health-related quality of life.
Measured: 1st, 3rd, 7th, and 14th days of treatment
Index of Orthodontic Treatment Need (IOTN)
Assessment of orthodontic treatment need and malocclusion severity using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC).
Measured: At baseline (before treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 May 2024
- Primary completion20 Nov 2024
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Neslihan Atmaca
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor-investigator, Neslihan Atmaca, Marmara University
- Investigators
- Neslihan Atmaca, Doctor of Dental Surgery, Principal investigator, Marmara Universty Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331090
- Sponsor's protocol ID
- MUPEDDENTNSL
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Removable Appliances and Clear Aligners in Terms of Multidimensional Parameters and Their Effects on Phonation in Early Orthodontic Treatments During the Mixed Dentition Period
- ClinicalTrials.gov ID
- NCT07331090
- Acronym / sponsor ID
- MUPEDDENTNSL
- Conditions
- Malocclusion, Crossbite
- Keywords
- Removable Orthodontic Appliances, Clear Aligners, Oral Health-Related Quality of Life, Phonation, Anxiety, Visual Analog Scale (VAS), Simplified Oral Hygiene Index (OHI-S), Index of Orthodontic Treatment Need (IOTN)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Neslihan AtmacaUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 15 May 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 9 Jan 2026 (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.
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
Detailed description
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
The mixed dentition period, occurring approximately between the ages of 6 and 12, represents a transitional developmental stage during which primary and permanent teeth coexist. In this phase, early diagnosis and treatment of orthodontic anomalies are particularly important to support functional, aesthetic, and psychosocial development and to minimize the need for more complex treatment in later stages.
Removable orthodontic appliances have traditionally been used to guide dental arch development, correct minor malocclusions, and eliminate harmful oral habits. Advances in digital technology have introduced clear aligners as an alternative treatment option that offers aesthetic and removable features. Despite their differences in design and material characteristics, both approaches are commonly used during early orthodontic treatment planning.
Orthodontic appliances may influence various aspects of oral function, including oral hygiene maintenance, periodontal health, caries risk, pain perception, anxiety levels, and speech performance. In growing children, treatment experiences may additionally shape cooperation, adaptation, and overall quality of life. Therefore, evaluating orthodontic interventions during the mixed dentition period requires consideration of not only mechanical efficiency but also broader functional and psychosocial parameters.
Orthodontic treatment need and malocclusion severity may also influence oral hygiene maintenance during treatment. Therefore, the present study additionally evaluates the relationship between orthodontic treatment need assessed using the IOTN and oral hygiene status assessed using the OHI-S at baseline and during the early treatment period. Appliance-related changes in intraoral volume and tongue movement may alter speech production, potentially affecting articulatory patterns and acoustic characteristics. Contemporary acoustic analysis methods, such as the use of specialized speech software, allow the objective measurement of frequency- and time-based acoustic parameters and provide complementary information to clinical observations.
This prospective study was designed to investigate how clear aligners and removable appliances influence oral hygiene status, pain and anxiety perception, oral health-related quality of life, orthodontic treatment need, and speech performance in children. Through standardized clinical assessments, validated questionnaires, and acoustic analysis, the study aims to generate multidimensional data that may guide clinical decision-making in early orthodontic treatment planning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with clear aligners | – | –Patients aged between 6 and 12 years who required early orthodontic treatment and started clear aligner therapy were included in the study. |
| Patients treated with removable orthodontic appliances | – | –Patients aged between 6 and 12 years who required early orthodontic treatment and started removable orthodontic appliance therapy were included in the study. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consisted of systemically healthy children aged 6-12 years who presented to the Clinics of the Departments of Pediatric Dentistry and Orthodontics at Marmara University Faculty of Dentistry with an initial need for orthodontic treatment.
Key inclusion criteria (6 listed)
- Children aged between 6 and 12 years who applied to the Clinics of the Departments of Pedodontics and Orthodontics at Marmara University Faculty of Dentistry were included in the study.
- Patients were required to present with anterior cross-bite type malocclusion.
- Participants had to be cooperative, native Turkish speakers, and have no systemic disease, syndrome, craniofacial anomaly, or known allergy.
- Individuals with no apparent oro-facial anomaly, no hearing or speech impairment, and no reading or language difficulties were included.
- Based on clinical and radiographic evaluations, only patients whose malocclusions were determined to be dental in origin (not skeletal) were selected.
Key exclusion criteria (2 listed)
- The study excluded patients who had severe periodontal disease, a history of systemic illness, a known allergy to any of the materials used in the study, poor oral hygiene, insufficient cooperation, or who did not agree to attend regular follow-up appointments during the study period.
- Additionally, individuals with craniofacial anomalies or skeletal-origin malocclusions were not included. Participants with hearing impairments, non-native Turkish speakers, or those with any disease or history of surgery that could affect voice or speech quality were also excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Formant frequencies (F1-F4) during speech production
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Evaluation of phonation changes during early orthodontic treatment by analysing the first four formant frequencies (F1-F4) obtained from standardized speech recordings. Recordings were collected immediately before appliance placement and on days 1, 3, 7, and 14 after appliance insertion. Words selected from a standardized articulation test were read aloud by the participants, and acoustic data were analysed using Praat software to assess treatment-related variations in vowel resonance patterns. Units: Hertz (Hz) Higher values indicate: Changes in vowel resonance characteristics potentially related to treatment-related alterations in oral cavity configuration.
11 secondary outcomes
Voice Onset Time (VOT)
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral Centre of Gravity (CoG)
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral skewness
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral kurtosis
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Plaque Index (PI; Silness & Löe)
Time frame: At baseline (before treatment) and 14th days of treatment.
Gingival Index (GI; Löe & Silness)
Time frame: At baseline (before treatment) and 14th days of treatment.
Simplified Oral Hygiene Index (OHI-S)
Time frame: At baseline (before treatment) and Day 14 of treatment.
Pain perception (Visual Analog Scale)
Time frame: 1st, 3rd, 7th, and 14th days of treatment
Anxiety levels during treatment (State-Trait Anxiety Inventory for Children)
Time frame: 1st, 3rd, 7th, and 14th days of treatment
Oral health-related quality of life during treatment (OHIP-14)
Time frame: 1st, 3rd, 7th, and 14th days of treatment
Index of Orthodontic Treatment Need (IOTN)
Time frame: At baseline (before treatment).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
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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. This study is not recruiting at the moment.
Neslihan Atmaca, Doctor of Dental Surgery principal investigator
Marmara Universty Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion and Crossbite, run by Neslihan Atmaca at 1 site in Turkey (Türkiye).
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 18 Jun 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Formant frequencies (F1-F4) during speech production (time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.). 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 18 Jun 2026.