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

Quality of Life Clinical Trial

Official title:

Impact of Anterior Dental Cross Bite Treatment on Children's Speech Performance and Their Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168695
• Other study ID #: #R-PED-1-23-6
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: Tanta University
• Contact: shaimaa eldesouky, lecturer
• Phone: +201008994242
• Email: shaimaaeldesouky[@]dent.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Cross Bite
• Malocclusion
• Quality of Life
• Speech

Intervention

Device:
• removable 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 Test:
• Speech 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.

Other:
• Oral 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.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	3 months
Secondary	Measured degree of speech improvement	The pre-treatment assessed speech sounds are compared with the post-treatment assessment	3 months