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

NCT04791813 | Unknown

• 1 other identifier: H92
• Study Type: observational
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage occurrence of dental abnormalities.

  Participants will be examined for once " day 1"

Study Arms (2)

Exposure group

group of surgically treated unilateral cleft lip and palate Egyptian children aged 9\_12years

Other: Alginate impressions , Photographic data and panoramic radiographs .

Control group

group of healthy Egyptian children aged 9\_12years

Other: Alginate impressions , Photographic data and panoramic radiographs .

Interventions

Alginate impressions , Photographic data and panoramic radiographs . OTHER

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; Exposure group

Eligibility Criteria

• Age: 9 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy Egyptian children aging from 9-12 years old

You may qualify if:

• 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 .

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hadir A Ali

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hadir A Ali, B.D.S

CONTACT

1127370868; Dr.hadeer.sarhan@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 10, 2021
• Study Start: March 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 10, 2022

Record last verified: 2022-02