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

Surgically Repaired Unilateral Cleft Lip and Palate Clinical Trial

Official title:

Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate: A Cross Sectional Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03219021
• Other study ID #: CEBD-2017-7-170
• Status: Not yet recruiting
• Phase: N/A
• First received: July 9, 2017
• Last updated: July 17, 2017
• Start date: July 2017
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: Menna Allah Mohammed Awad, Master
• Phone: +201146629499
• Email: amenna36[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 233
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Cleft Lip
• Surgically Repaired Unilateral Cleft Lip and Palate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menna Allah Mohammed Awad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	arch dimensions measures	Assessment of arch dimensions among children with surgically repaired unilateral cleft lip and palate in mm using digital caliper	Day 1