Cross BiteNCT06168695
Impact of Anterior Cross Bite Treatment on Children's Speech Performance
A study testing removable anterior expansion screw, Speech and language evaluation and Oral Health Related Quality of Life (OHRQoL) Assessment in people with Cross Bite and Malocclusion, run by Tanta University at 1 site in Egypt.
Trial summary
The goal of this prospective, single-arm clinical trial is to evaluate the speech performance of children with anterior dental crossbite before and after correction. Also, to assess the impact of early interceptive orthodontic treatment in the mixed dentition stage to correct the anterior dental crossbite on the… Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Cross Bite, Malocclusion, Speech
- What is being tested?
- removable anterior expansion screw, Speech and language evaluation and Oral Health Related Quality of Life (OHRQoL) Assessment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Feb 2023to Dec 2026
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- healthy cooperative children aged 8-10 years
- have at least one or more maxillary permanent incisors in a crossbite relationship
- fully erupted four first permanent molars
- Angle Class I molar relationship and Class I skeletal relationship
- the mother language of all the subjects was Arabic.
Who cannot join
- Children with systemic illness or previous history of speech therapy
- children who are ill-habituated or unable to follow up
- children with previous orthodontic treatment
- uncooperative children
- Anterior skeletal or functional crossbite
- presence of sucking habits
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
Tanta University
Tanta, Gharbia Governorate, 6624033
Shaimaa eldesouky, PhD, +201008994242, shiamaaeldesouky@dent.tanta.edu.eg
shimaa hadwa, PhD, 01115535527, shimaa.hadwa@dent.tanta.edu.eg
About this study
Official title: Impact of Anterior Dental Cross Bite Treatment on Children's Speech Performance and Their Quality of Life
The goal of this prospective, single-arm clinical trial is to evaluate the speech performance of children with anterior dental crossbite before and after correction. Also, to assess the impact of early interceptive orthodontic treatment in the mixed dentition stage to correct the anterior dental crossbite on the quality of life of children.
Fifty children of both sexes aged from 8 to 10 years were enrolled and evaluated using the study's inclusion \& exclusion criteria. before beginning interceptive orthodontic treatment, each child underwent full mouth treatment. then, using a removable anterior expansion screw along with posterior bite planes to treat the anterior crossbite. All children were subjected to the Protocol of speech evaluation before appliance insertion and after complete correction of anterior crossbite. Also, the Child Perceptions Questionnaire (CPQ 8-10) in the Brazilian version was used to gauge how the anterior crossbite affected the children's oral health-related quality of life.
- Conditions
- Cross Bite, Malocclusion, Speech, Quality of Life
- Being tested
- removable anterior expansion screw, Speech and language evaluation, Oral Health Related Quality of Life (OHRQoL) Assessment
- Keywords
- crossbite, speech, expansion screw, quality of life
- Medical subject headings
- Malocclusion, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removable anterior expansion screwDevice
For the upper and lower arches, precise and profound alginate impressions were obtained and plaster study models were created. The removable appliance was constructed using acrylic resin with bilateral occlusal coverage for posterior teeth. The removable appliance was inserted in the patient's mouth and the patient was recalled after 24 hours to check the appliance fit.
Patient was recalled every four weeks until the dental cross-bite was corrected.
Speech and language evaluationDiagnostic test
speech evaluation was done by a Phoniatrician and all children were subjected to the Protocol of speech evaluation before expansion screw appliance insertion and after complete correction of anterior crossbite using an articulation test, intelligibility test, and spectrographic analysis.
- Articulation test: Five speech sounds were chosen to be studied /s/, /s /, /z/, /z/, /∫ /. The consonants were tested in the initial, medial, and final word positions.
- Speech intelligibility test : The general intelligibility score was calculated using Speech intelligibility in context: 5 -point scale:
- Spectrographic analysis: Using the computerized speech lab, the child was seated in an upright position \& allowed to talk freely \& repeated syllables were said to him/her.
Oral Health Related Quality of Life (OHRQoL) AssessmentOther
The Child Perceptions Questionnaire (CPQ 8-10) in Brazilian version was used to gauge how the anterior cross bite affected the children's OHRQoL. It has twenty-five items total, broken down into four health domains (subscales): five questions each about oral symptoms (OS), five questions about functional limitations (FL), five questions about emotional wellbeing (EW), and ten questions about social well-being (SW). The responses never (0), once/twice (1), occasionally (2), often (3), and every day/almost every day (4) are provided for each question on an ordinal scale. The sum of the scores for all questions is used to calculate the scores for each subscale. The CPQ 8-10 was used to assess the OHRQoL before appliance insertion and after complete correction of anterior crossbite.
| Study group | Role | What they receive |
|---|---|---|
| anterior crossbite treatment with evaluation of speech and quality of life | Experimental | removable anterior expansion screw is used to correct anterior crossbite
Child Perceptions Questionnaire was used to gauge how the anterior crossbite affected the children's OHRQoL.
children were subjected to the Protocol of speech evaluation Receives: Device: removable anterior expansion screw; Diagnostic Test: Speech and language evaluation; Other: Oral Health Related Quality of Life (OHRQoL) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal anterior occlusion, no anterior crossbite, normal measured Overjet and Overbite
Normal occlusion is measured as:
no anterior crossbite Overbite 1 mm to 4 mm Overjet 1mm to 4 mm
Measured: 3 months
Secondary outcomes (2)
child compliance, oral health-related quality of life questionnaire
The earlier tested questionnaire is used to compare child compliance before and after anterior crossbite correction
Measured: 3 months
Measured degree of speech improvement
The pre-treatment assessed speech sounds are compared with the post-treatment assessment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start4 Feb 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cross BiteStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Shaban Mohamed El-desouky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168695
- Sponsor's protocol ID
- #R-PED-1-23-6
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Littlewood SJ, Tait AG, Mandall NA, Lewis DH. The role of removable appliances in contemporary orthodontics. Br Dent J. 2001 Sep 22;191(6):304-6, 309-10. doi: 10.1038/sj.bdj.4801170.
PubMed 11587502Assaf DDC, Knorst JK, Busanello-Stella AR, Ferrazzo VA, Berwig LC, Ardenghi TM, Marquezan M. Association between malocclusion, tongue position and speech distortion in mixed-dentition schoolchildren: an epidemiological study. J Appl Oral Sci. 2021 Aug 16;29:e20201005. doi: 10.1590/1678-7757-2020-1005. eCollection 2021.
PubMed 34406316Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res. 2002 Jul;81(7):459-63. doi: 10.1177/154405910208100705.
PubMed 12161456
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anterior Dental Cross Bite Treatment on Children's Speech Performance and Their Quality of Life
- ClinicalTrials.gov ID
- NCT06168695
- Acronym / sponsor ID
- #R-PED-1-23-6
- Conditions
- Cross Bite, Malocclusion, Speech, Quality of Life
- Keywords
- crossbite, speech, expansion screw, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Dec 2023 (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.
The goal of this prospective, single-arm clinical trial is to evaluate the speech performance of children with anterior dental crossbite before and after correction. Also, to assess the impact of early interceptive orthodontic treatment in the mixed dentition stage to correct the anterior dental crossbite on the quality of life of children.
Fifty children of both sexes aged from 8 to 10 years were enrolled and evaluated using the study's inclusion \& exclusion criteria. before beginning interceptive orthodontic treatment, each child underwent full mouth treatment. then, using a removable anterior expansion screw along with posterior bite planes to treat the anterior crossbite. All children were subjected to the Protocol of speech evaluation before appliance insertion and after complete correction of anterior crossbite. Also, the Child Perceptions Questionnaire (CPQ 8-10) in the Brazilian version was used to gauge how the anterior crossbite affected the children's oral health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| anterior crossbite treatment with evaluation of speech and quality of life | Experimental | Device: removable anterior expansion screw, Diagnostic Test: Speech and language evaluation, Other: Oral Health Related Quality of Life (OHRQoL) Assessmentremovable anterior expansion screw is used to correct anterior crossbite Child Perceptions Questionnaire was used to gauge how the anterior crossbite affected the children's OHRQoL. children were subjected to the Protocol of speech evaluation |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- healthy cooperative children aged 8-10 years
- have at least one or more maxillary permanent incisors in a crossbite relationship
- fully erupted four first permanent molars
- Angle Class I molar relationship and Class I skeletal relationship
- the mother language of all the subjects was Arabic.
Key exclusion criteria (6 listed)
- Children with systemic illness or previous history of speech therapy
- children who are ill-habituated or unable to follow up
- children with previous orthodontic treatment
- uncooperative children
- Anterior skeletal or functional crossbite
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 anterior expansion screwFor the upper and lower arches, precise and profound alginate impressions were obtained and plaster study models were created. The removable appliance was constructed using acrylic resin with bilateral occlusal coverage for posterior teeth. The removable appliance was inserted in the patient's mouth and the patient was recalled after 24 hours to check the appliance fit. Patient was recalled every four weeks until the dental cross-bite was corrected. | Device | anterior crossbite treatment with evaluation of speech and quality of life |
| Speech and language evaluationspeech evaluation was done by a Phoniatrician and all children were subjected to the Protocol of speech evaluation before expansion screw appliance insertion and after complete correction of anterior crossbite using an articulation test, intelligibility test, and spectrographic analysis. * Articulation test: Five speech sounds were chosen to be studied /s/, /s /, /z/, /z/, /∫ /. The consonants were tested in the initial, medial, and final word positions. * Speech intelligibility test : The general intelligibility score was calculated using Speech intelligibility in context: 5 -point scale: * Spectrographic analysis: Using the computerized speech lab, the child was seated in an upright position \& allowed to talk freely \& repeated syllables were said to him/her. | Diagnostic test | anterior crossbite treatment with evaluation of speech and quality of life |
| Oral Health Related Quality of Life (OHRQoL) AssessmentThe Child Perceptions Questionnaire (CPQ 8-10) in Brazilian version was used to gauge how the anterior cross bite affected the children's OHRQoL. It has twenty-five items total, broken down into four health domains (subscales): five questions each about oral symptoms (OS), five questions about functional limitations (FL), five questions about emotional wellbeing (EW), and ten questions about social well-being (SW). The responses never (0), once/twice (1), occasionally (2), often (3), and every day/almost every day (4) are provided for each question on an ordinal scale. The sum of the scores for all questions is used to calculate the scores for each subscale. The CPQ 8-10 was used to assess the OHRQoL before appliance insertion and after complete correction of anterior crossbite. | Other | anterior crossbite treatment with evaluation of speech and quality of life |
Primary outcome
normal anterior occlusion, no anterior crossbite, normal measured Overjet and Overbite
Time frame: 3 months
Normal occlusion is measured as: no anterior crossbite Overbite 1 mm to 4 mm Overjet 1mm to 4 mm
2 secondary outcomes
child compliance, oral health-related quality of life questionnaire
Time frame: 3 months
Measured degree of speech improvement
Time frame: 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 7 Oct 2026.
- Background: PubMed 11587502Littlewood SJ, Tait AG, Mandall NA, Lewis DH. The role of removable appliances in contemporary orthodontics. Br Dent J. 2001 Sep 22;191(6):304-6, 309-10. doi: 10.1038/sj.bdj.4801170.
- Background: PubMed 34406316Assaf DDC, Knorst JK, Busanello-Stella AR, Ferrazzo VA, Berwig LC, Ardenghi TM, Marquezan M. Association between malocclusion, tongue position and speech distortion in mixed-dentition schoolchildren: an epidemiological study. J Appl Oral Sci. 2021 Aug 16;29:e20201005. doi: 10.1590/1678-7757-2020-1005. eCollection 2021.
- Background: PubMed 12161456Jokovic A, Locker D, Stephens M, Kenny D, Tompson B, Guyatt G. Validity and reliability of a questionnaire for measuring child oral-health-related quality of life. J Dent Res. 2002 Jul;81(7):459-63. doi: 10.1177/154405910208100705.
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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 anterior expansion screw, Speech and language evaluation and Oral Health Related Quality of Life (OHRQoL) Assessment in people with Cross Bite and Malocclusion, run by Tanta 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 5 inclusion and 6 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 7 Oct 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 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 shaimaa eldesouky, lecturer (+201008994242, shaimaaeldesouky@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal anterior occlusion, no anterior crossbite, normal measured Overjet and Overbite (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168695, which also lists 3 linked publications.
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 7 Oct 2026.