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

Sponsor

Cairo University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04791813

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip and Palate	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 Design

Study Type:

Observational

Anticipated Enrollment :

38 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	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.

Arm

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 .

Outcome Measures

Primary Outcome Measures

Inter canine maxillary arch width at the gingival level and 2. Inter molar maxillary arch Width at gingival level 3. Maxillary arch depth [Participants will be examined for once "day1"]
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.

Secondary Outcome Measures

Percentage occurrence of dental abnormalities. [Participants will be examined for once " day 1"]
Percentage occurrence of hypodontia and other dental abnormalities.

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 .

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Hadir A Ali, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadir ahmed ali hassan, Principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT04791813

Other Study ID Numbers:

First Posted:

Mar 10, 2021

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cleft Lip

Study Results

No Results Posted as of Mar 10, 2022