Clinical trial NCT03219021: Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate
Official title: Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate: A Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgically Repaired Unilateral Cleft Lip and Palate
Keywords: Cleft lip and Palate
unilateral cleft lip and palate
surgically repaired cleft lip and palate
arch dimensions
arch discrepancies
dental arch dimensions
arch parameter
arch circumference
intercanine width
first deciduous molar width
second deciduous molar width
permanent first molar width
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 233
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with surgically repaired unilateral cleft lip and palate

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: arch dimensions measures
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: