Transverse Facial Cleft Repair Using Precise Location of Commissure

NCT ID: NCT03282721

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2016-12-30

Brief Summary

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To compare the effect of redesigned transverse facial cleft treatment and traditional transverse facial cleft treatment.

Detailed Description

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Nine patients with transverse facial cleft were treated with redesigned repair using precise location of commissure. The main outcome measurement included scar, symmetry of the commissure. They were graded in five scores by five resident physicians who had never seen the patients. The results were compared with healthy controls.

Conditions

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Transverse Facial Cleft

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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redesigned

the commissure constructions of the cleft side were precised located, include the upper and lower inherent vermilion border, the interior commissure, the outline of commissure, the exterior commissure, the upper skin-mucosa junction and the lower skin-mucosa junction.

precise location of commissure

Intervention Type PROCEDURE

classical

follows the simple-symmetry rule, the commissure of the healthy side is measured, and then the affected side is located accordingly.

No interventions assigned to this group

Interventions

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precise location of commissure

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of transverse facial cleft disease;
* Must not received any lip surgeries before;
* Such disease can be accompanied by external ear abnormalities, hypoplastic mandible, cleft lip and palate.

Exclusion Criteria

* Severe general diseases;
* Patients who had been treated with lip surgery;
* Patients and/or his/her family didn't want to continue the clinical trial.
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lian Zhou

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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LIAN ZHOU, D.D.S

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Other Identifiers

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S-K338

Identifier Type: -

Identifier Source: org_study_id

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