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

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

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

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 233

Contacts and Locations

• Study Contact: Name: Menna Allah Mohammed Awad, Master; Phone Number: +201146629499; Email: amenna36@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children with surgically repaired unilateral cleft lip and palate

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
arch dimensions measures	Assessment of arch dimensions among children with surgically repaired unilateral cleft lip and palate in mm using digital caliper	Day 1

Collaborators and Investigators

• Sponsor: Menna Allah Mohammed Awad

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 9, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: unilateral cleft lip and palate; 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
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: CEBD-2017-7-170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No