Clinical Evaluation of Re-treatment of Cleft Lip and Nasal Deformation in Patients With Post Repair Deformities

January 8, 2026 updated by: Suez Canal University

Clinical Evaluation of Re-treatment of Cleft Lip and Nasal Deformation in Patients With Post Repair Deformities. A Single Group Study

Clinical Evaluation of Re-treatment of Cleft Lip and Nasal Deformation in Patients With Post Repair Deformities. A Randomized Controlled Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cleft lip and palate are among the most common congenital craniofacial anomalies, affecting approximately 1 in every 700 live births worldwide. These deformities can have a profound impact on both the appearance and function of the face, particularly the upper lip and nose The etiology and mode of transmission of CLP is very complex because of the congenital anomalies that are associated with it. The etiological factors include heredity, fetal environment, and environmental risk factors for CL/P such as stress, consanguinity, smoking, alcohol ingestion, use of medication during pregnancy, insufficient ingestion of folic acid in the pregestational period and in the first quarter of pregnancy, a past of miscarriage and/or stillbirth, maternal diseases, and a family history of clefts. CLP is polygenic and multifactorial involving both genetic and environmental influences.

Primary surgical repair is usually performed within the first year of life to restore anatomical continuity and function, many patients are left with residual deformities that become more apparent with growth and facial development. These secondary deformities especially involving the lip, nose, and surrounding soft tissue can significantly affect speech, feeding, dentofacial growth, and psychosocial well-being.

The secondary cleft lip and nasal deformities result from multiple factors, including scar contracture, inadequate muscle alignment, asymmetrical healing, or underlying skeletal discrepancies. The most frequently reported issues include lip tightness or shortening, irregular cupid's bow, nostril asymmetry, alar collapse, nasal septum deviation, and hypertrophic or immature scarring. Such deformities not only compromise facial aesthetics but also negatively impact the patient's psychological and social life, especially during adolescence and early adulthood.

Secondary surgical correction plays a vital role in addressing these residual issues. These procedures may include scar revision techniques such as Z-plasty or V-Y advancement, nasal tip or alar reshaping, septoplasty, cartilage grafting, fat or dermal filler injections, and lip muscle repositioning. The goal of these interventions is to restore function, achieve better symmetry, and improve the patient's overall quality of life. While the primary aim of early cleft repair is to ensure basic function and appearance, secondary interventions are often more nuanced, focusing on refinement, symmetry, and psychosocial outcomes.

Assessment of these procedures, however, must go beyond traditional clinical evaluation. Patient-reported outcome measures (PROMs) such as the CLEFT-Q have emerged as validated tools that allow the patient's voice to be integrated into outcome assessment. The CLEFT-Q assesses multiple domains including facial appearance, speech, eating, school and social functioning, and psychological well-being. It is an essential instrument for understanding the true impact of secondary cleft surgeries from the patient's perspective.

This study aimed to evaluate and manage the reconstructed cleft lip and nose deformities and secondary correction results.

The current comparative clinical study conducted at the Department of Maxillofacial Surgery Faculty of Medicine, performed on sixteen patients with Maldon cleft lip and noses.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Ismailia, Egypt
        • Faculty of dentistry - Suez Canal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with cleft lip with or without nose deformities who had undergone primary lip repair but had not yet been repaired in children and adult.

Exclusion Criteria:

  • Cleft lip patients are associated with other maxillofacial congenital malformations.
  • Patient, parents or care giver who did not agree to participate in the study.
  • Uncooperative patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Twenty five patients who will have a secondary repair for cleft lip or nasal deformities.
Procedure: Procedure / Surgery
Procedure / Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CLEFT-Q
Time Frame: Postoperative follow-up every week for 1 month, then after 3 and 6 months

- The CLEFT-Q is a rigorously developed patient-reported outcome (PRO) measure that can be used internationally to collect and compare evidencebased outcomes data from patients with cleft lip and/or palate (CL/P).

The CLEFT-Q is composed of 12 independently functioning scales and checklist.

- Postoperative follow-up every week for 1 month, then after 3 and 6 months will be examined face, nose, nostrils, teeth, jaws, cleft, lip scar, psychological function, school function, social function speech distress, eating and drinking according to CLEFT-Q© Scales: CLEFT-Q© Scales: The CLEFT-Q© scales include number of items, ages and cleft type, recall period for completing and grade reading level.
Postoperative follow-up every week for 1 month, then after 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2025

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 723/2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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