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RecruitingNCT06168695Updated Oct 7, 2026

Impact of Anterior Cross Bite Treatment on Children's Speech Performance

An interventional study of removable anterior expansion screw and Speech and language evaluation in Cross Bite, Malocclusion and Speech, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 8 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

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

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Feb 2023, registered Dec 2023).
  • Started Feb 2023; still recruiting 3 years 9 months later.
Updated Oct 7, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
8 Years to 10 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Cross Bite
  • Malocclusion
  • Speech
  • Quality of Life

Keywords

  • crossbite
  • speech
  • expansion screw
  • quality of life
03

In context

Malocclusion

323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.

This study's planned enrollment of 50 is above the median of 37 across 242 interventional studies indexed under Malocclusion.

Browse Malocclusion studies →

Lead sponsor

Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
8 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    anterior crossbite treatment with evaluation of speech and quality of life

    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

    Device: removable anterior expansion screw · Diagnostic Test: Speech and language evaluation · Other: Oral Health Related Quality of Life (OHRQoL) Assessment

Interventions

  • Deviceremovable anterior expansion screw

    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.

  • Diagnostic testSpeech and language evaluation

    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.

  • OtherOral Health Related Quality of Life (OHRQoL) Assessment

    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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. Measured degree of speech improvement

    The pre-treatment assessed speech sounds are compared with the post-treatment assessment

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 11587502 ↗
  • Assaf 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 34406316 ↗
  • Jokovic 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 ↗
09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added, 1 site removed
Show site
  • Tanta University · Tanta, Egypt
Show 1 removed
  • Tanta University · Tanta, Egypt
Oct 7, 2026
Primary completion
May 2025→Nov 2026
Oct 7, 2026
Study completion
Jun 2025→Dec 2026
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    1 site added, 1 site removed
    Show site
    • Tanta University · Tanta, Egypt
    Show 1 removed
    • Tanta University · Tanta, Egypt
    Primary completion May 2025→Nov 2026
    Study completion Jun 2025→Dec 2026
    + 4 other changes: verification date, oversight details, data sharing statement and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06168695
Lead sponsor
Tanta University
Responsible party
Shaimaa Shaban Mohamed El-desouky (Lecturer of Pediatric dentistry, Tanta University) — Principal investigator
First posted
Dec 13, 2023
Start date
Feb 4, 2023
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 7, 2026

Study contacts

shaimaa eldesouky, lecturer
Contact
shaimaaeldesouky@dent.tanta.edu.eg
+201008994242
shimaa hadwa, lecturer
Contact
shimaa.hadwa@dent.tanta.edu.eg
01115535527

Oversight

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

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