NCT06168695

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

2.2 years

First QC Date

December 5, 2023

Last Update Submit

April 15, 2025

Conditions

Keywords

crossbitespeechexpansion screwquality of life

Outcome Measures

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

    3 months

Secondary Outcomes (2)

  • child compliance, oral health-related quality of life questionnaire

    3 months

  • Measured degree of speech improvement

    3 months

Study Arms (1)

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

Device: removable anterior expansion screwDiagnostic Test: Speech and language evaluationOther: Oral Health Related Quality of Life (OHRQoL) Assessment

Interventions

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.

anterior crossbite treatment with evaluation of speech and quality of life

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.

anterior crossbite treatment with evaluation of speech and quality of life

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.

anterior crossbite treatment with evaluation of speech and quality of life

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 6624033, Egypt

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11587502BACKGROUND
  • 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.

    PMID: 34406316BACKGROUND
  • 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.

    PMID: 12161456BACKGROUND

MeSH Terms

Conditions

MalocclusionSpeech

Interventions

Quality of LifeRestraint, Physical

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesVerbal BehaviorCommunicationBehavior

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public HealthBehavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

shaimaa eldesouky, lecturer

CONTACT

shimaa hadwa, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective, single-arm clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric dentistry

Study Record Dates

First Submitted

December 5, 2023

First Posted

December 13, 2023

Study Start

February 4, 2023

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations