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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03219021
Recruitment Status : Unknown
Verified July 2017 by Menna Allah Mohammed Awad, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : July 17, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Menna Allah Mohammed Awad, Cairo University

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

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 233 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate: A Cross Sectional Study
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017





Primary Outcome Measures :
  1. arch dimensions measures [ Time Frame: Day 1 ]
    Assessment of arch dimensions among children with surgically repaired unilateral cleft lip and palate in mm using digital caliper



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children with surgically repaired unilateral cleft lip and palate
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219021


Contacts
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Contact: Menna Allah Mohammed Awad, Master +201146629499 amenna36@hotmail.com

Sponsors and Collaborators
Menna Allah Mohammed Awad
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Responsible Party: Menna Allah Mohammed Awad, Master Student in department of pedodontics, Cairo University
ClinicalTrials.gov Identifier: NCT03219021    
Other Study ID Numbers: CEBD-2017-7-170
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Menna Allah Mohammed Awad, Cairo University:
Cleft lip and Palate
unilateral 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:
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Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities