- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168695
Impact of Anterior Cross Bite Treatment on Children's Speech Performance
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: shaimaa eldesouky, lecturer
- Phone Number: +201008994242
- Email: shaimaaeldesouky@dent.tanta.edu.eg
Study Contact Backup
- Name: shimaa hadwa, lecturer
- Phone Number: 01115535527
- Email: shimaa.hadwa@dent.tanta.edu.eg
Study Locations
-
-
Gharbia
-
Tanta, Gharbia, Egypt, 6624033
- Recruiting
- Tanta University
-
Contact:
- Shaimaa eldesouky, PhD
- Phone Number: +201008994242
- Email: shiamaaeldesouky@dent.tanta.edu.eg
-
Contact:
- shimaa hadwa, PhD
- Phone Number: 01115535527
- Email: shimaa.hadwa@dent.tanta.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 |
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 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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
child compliance, oral health-related quality of life questionnaire
Time Frame: 3 months
|
The earlier tested questionnaire is used to compare child compliance before and after anterior crossbite correction
|
3 months
|
Measured degree of speech improvement
Time Frame: 3 months
|
The pre-treatment assessed speech sounds are compared with the post-treatment assessment
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #R-PED-1-23-6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaActive, not recruitingImprove Quality of LifeItaly
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
University of South CarolinaNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingHealth Related Quality of LifeUnited States
-
PharmanexSprim Advanced Life SciencesCompletedHealth-related Quality of LifeUnited States
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on removable anterior expansion screw
-
Cairo UniversityNot yet recruiting
-
Universiti Sains MalaysiaAl-Azhar UniversityRecruiting
-
Universitaire Ziekenhuizen KU LeuvenKarolinska Institutet; The University of Hong Kong; University of Copenhagen; Palacky...Not yet recruitingTooth Impaction | Canine Teeth
-
Damascus UniversityCompletedConstrictionSyrian Arab Republic
-
Uppsala University HospitalÖrebro County Council; Uppsala County Council, SwedenCompleted
-
Damascus UniversityCompletedPosterior CrossbiteSyrian Arab Republic
-
Zimmer BiometCompleted
-
Medical University of ViennaCompleted
-
AO Clinical Investigation and Publishing DocumentationTerminatedSingle Level Stable Thoracolumbar Fracture Type AO A3 | Multiple Level Stable Thoracolumbar Fracture Type AO A3Brazil, Germany, Chile, Czechia, Italy, Portugal