Speech DisordersNCT01180309
Lingual Frenum and Articulation of Phonemes
An observational study of Speech Disorders, run by Fortaleza University at 1 site in Brazil.
Trial summary
Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes. Methods This is a quantitative observational study, the individual operative kind with transversal time reference. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Speech Disorders
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Aug 2010
- 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 7 years and older
- All sexes
- Child, Adult, Older adult
Study population: The total study population consisted of subjects with complete phonological system, ie more than seven years of chronological age, both male and female, accompanied in the field of Dentistry, University of Fortaleza - UNIFOR.
Who may be able to join
- patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side
Who cannot join
- patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lingual Frenum and Possible Alterations in the Articulation of Phonemes
Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes.
Methods This is a quantitative observational study, the individual operative kind with transversal time reference. The population sample consisted of 16 individuals, each one with their phonological system complete. The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.
Read the detailed description
The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.
- Conditions
- Speech Disorders
- Keywords
- Tongue frenum, Lingual frenum, Audio Phonology, Speech disorders
- Medical subject headings
- Speech 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 |
|---|---|---|
| lingual frenum alterations | individuals each one with their phonological system complete |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between lingual frenulum altered and articulation phonetics
The quantitative assessment, we could classify the lingual frenulum as normal, values above 60%; questions to amend the frenulum-values between 50% and 60% and changed (short and / or anterior)-values below 50%.
Finally, we carried out the assessment phonetics (AF) and it was applied Exam 12 Phonetic-Phonological ERT. This test, is composed of 78 pictures phonologically balanced, lexical repertoire familiar to the individual and easily recognizable pictorial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startJun 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech DisordersStudies 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
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Collaborators
- Izabella Santos Nogueira de Andrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180309
- Sponsor's protocol ID
- RLeite
- Status last verified
- Aug 2010
- First submitted
- 4 Aug 2010
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lingual Frenum and Possible Alterations in the Articulation of Phonemes
- ClinicalTrials.gov ID
- NCT01180309
- Acronym / sponsor ID
- RLeite
- Conditions
- Speech Disorders
- Keywords
- Tongue frenum, Lingual frenum, Audio Phonology, Speech disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Collaborators
- Izabella Santos Nogueira de Andrade
- Study start
- Jun 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 12 Aug 2010 (estimated)
- 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.
Purpose To investigate the relationship between lingual frenum and possible alterations in the articulation of phonemes.
Methods This is a quantitative observational study, the individual operative kind with transversal time reference. The population sample consisted of 16 individuals, each one with their phonological system complete. The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.
Detailed description
The data were captured through an application form that contained relevant aspects as to the qualitative-classification of the lingual frenum, quantitative-relation of mouth opening, with and without the tongue in the papillae, tongue mobility and ERT - 78 phonologically balanced words.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lingual frenum alterations | – | –individuals each one with their phonological system complete |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The total study population consisted of subjects with complete phonological system, ie more than seven years of chronological age, both male and female, accompanied in the field of Dentistry, University of Fortaleza - UNIFOR.
Key inclusion criteria (1 listed)
- patients with the frenulum of the tongue - the presence of the central incisors and upper and lower side
Key exclusion criteria (1 listed)
- patients in speech therapy aimed at enabling oral motor or speech - without integrity orofacial motor - patients using grid palate - with changes in the temporomandibular joint - anterior open bite
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
Relation between lingual frenulum altered and articulation phonetics
The quantitative assessment, we could classify the lingual frenulum as normal, values above 60%; questions to amend the frenulum-values between 50% and 60% and changed (short and / or anterior)-values below 50%. Finally, we carried out the assessment phonetics (AF) and it was applied Exam 12 Phonetic-Phonological ERT. This test, is composed of 78 pictures phonologically balanced, lexical repertoire familiar to the individual and easily recognizable pictorial.
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 12 Aug 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Speech Disorders, run by Fortaleza University at 1 site in Brazil.
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 1 inclusion and 1 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 12 Aug 2010. 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 Brazil. 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?
Relation between lingual frenulum altered and articulation phonetics. 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 12 Aug 2010.