Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate

NCT ID: NCT03219021

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-31

Study Completion Date

2017-07-31

Brief Summary

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The aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate.

Detailed Description

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Measurements of arch widths will be performed in the maxillary and mandibular arches after performing a study cast. Alginate impression of the upper and lower arch of all participating children will be performed and poured immediately to prevent dimensional changes.

The inter-deciduous canine, inter-permanent molar, and the distances between the first and second deciduous molars will be measured using a digital caliper directly on dental casts by a single examiner.

Distance measurements will be obtained between cusp tips of canines, cusp tips of first deciduous molars, mesiobuccal cusp tips of second deciduous molars, and mesiobuccal cusp tips of first permanent molars. Estimated cusp tips will be used in cases of wear facets.

Rationale:

Children with cleft lip and/or palate suffer from problems in growth of the jaws, particularly the maxilla (upper jaw), as a result of surgical repairs of the cleft lip and palate. It is important to know the arch dimensions of them to enable the identification of specific surgical alterations related to maxillofacial growth concerning the common treatment protocol for patients with cleft lip and palate.

Benefits to the practitioner:

-Increase the awareness of pediatric dentists about changes of arch dimensions of surgically repaired cleft lip and palate patients in Egypt.

Benefits to the patient:

* Inform parents about any disturbances that might be associated with Cleft lip and Palate.
* Guide them to the orthodontic care if needed.

Benefits to the community:

* Provide the Egyptian community with data concerning patients with cleft lip and palate.
* Increase awareness of problems related to Cleft Lip and Palate.

Conditions

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Surgically Repaired Unilateral Cleft Lip and Palate

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* Children with cleft lip and palate from the age group: 8-10 years.
* Unilateral Cleft lip and palate children.
* Children who had been operated with lip and palate closure

Exclusion Criteria

* Cleft lip and palate patients with systemic diseases, autoimmune conditions, syndromes.
* Children with any arch expansion or orthodontic procedure or previous history of orthodontic treatment.
* The presence of early loss of deciduous molars.
* Parents refusing participation in the study
Minimum Eligible Age

8 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Menna Allah Mohammed Awad

OTHER

Sponsor Role lead

Responsible Party

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Menna Allah Mohammed Awad

Master Student in department of pedodontics

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Menna Allah Mohammed Awad, Master

Role: CONTACT

+201146629499

Other Identifiers

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CEBD-2017-7-170

Identifier Type: -

Identifier Source: org_study_id

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