Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Children Versus Normal Children .

Assessment of Maxillary Arch Depth and Width in a Group of Surgically Repaired Unilateral Cleft Lip and Palate Egyptian Children Versus Normal Children .A Cross Sectional Study

The aim of the present study is to determine the effect of surgically repaired UCLP on dental arch dimensions and the need for orthodontic intervention in comparison with other healthy children , the presence of dental anomalies and the best possible standards of care among this group of Egyptian children.

Study Overview

• Status: Not yet recruiting
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Other: Alginate impressions , Photographic data and panoramic radiographs .

Detailed Description

In arranging to distinguish and implement the best possible standards of care for UCLP children by the pediatric dental practitioner, evaluation of early treatment results after essential surgical repair of cleft lip and palate with respect to arch dimensions is fundamental. Although the dental arch dimensions for these children have been evaluated in previous studies , few examiners in Egypt handled this issue Due to racial contrasts in improvement of the dental arch and growth .The deficiency of data in Egypt tending to this insufficient assemble of children presents a gap that prevents the transport of fitting dental care to them. This is considered objective to fulfill this gap by spotting the most characteristics of dental arch dimensions in surgically repaired UCLP children and compares them with those of sound, coordinating, non-cleft.

• Study Type: Observational
• Enrollment (Anticipated): 38

Contacts and Locations

• Study Contact: Name: Hadir A Ali, B.D.S; Phone Number: 0020 1127370868; Email: Dr.hadeer.sarhan@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Egyptian children aging from 9-12 years old

Description

Inclusion Criteria:

• Cooperative Egyptian children aging from ( 9-12) years.
• Medically free children.
• Children whose families accepts to participate in this study.
• Children with surgically repaired UCLP .

Exclusion Criteria:

• Children with previous untreated dental trauma.
• Children with previous orthodontic treatment
• Children with upper respiratory disease
• Children having any systemic diseases
• Intellectual disabilities or syndromes
• Congenital anomalies other than UCLP were excluded from the study .

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposure group; group of surgically treated unilateral cleft lip and palate Egyptian children aged 9_12years	Other: Alginate impressions , Photographic data and panoramic radiographs .; Upper and lower alginate impressions will be poured and dental casts produced and converted to 3D digital cast using a 3D scanner-(3Shape )-the 3D data will be imported to a revers modeling software . Also Photographic data using Canon750 camera and panoramic radiographs to be taken.
Control group; group of healthy Egyptian children aged 9_12years	Other: Alginate impressions , Photographic data and panoramic radiographs .; Upper and lower alginate impressions will be poured and dental casts produced and converted to 3D digital cast using a 3D scanner-(3Shape )-the 3D data will be imported to a revers modeling software . Also Photographic data using Canon750 camera and panoramic radiographs to be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth	Inter canine maxillary arch width at the gingival level(between cusp tips of the right and left primary or permanent canines) 2. Inter molar maxillary arch Width at the gingival level(between mesio- buccul cusp tips of right and left first molars) 3. Maxillary arch depth( from the median point between central incisors to the tangent line between the distal surfaces of the second primary molars or mesial surfaces of first permanent molar.	Participants will be examined for once "day1"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage occurrence of dental abnormalities.	Percentage occurrence of hypodontia and other dental abnormalities.	Participants will be examined for once " day 1"

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hadir A Ali, Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (ACTUAL): March 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 23, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: H92

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Subject age, gender, maxillary arch dimensions, and dental anomalies found.

Drug and device information, study documents

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