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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04791813
Other study ID # H92
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 2022
Est. completion date October 2022

Study information

Verified date February 2022
Source Cairo University
Contact Hadir A Ali, B.D.S
Phone 1127370868
Email Dr.hadeer.sarhan@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 38
Est. completion date October 2022
Est. primary completion date September 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage occurrence of dental abnormalities. Percentage occurrence of hypodontia and other dental abnormalities. Participants will be examined for once " day 1"
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