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

NCT ID: NCT07348185

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-12-01

Brief Summary

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

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.

Conditions

Re-treatment of Cleft Lip and Nasal Deformation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Twenty five patients who will have a secondary repair for cleft lip or nasal deformities.

Twenty five patients who will have a secondary repair for cleft lip or nasal deformities.

Group Type: OTHER

Procedure / Surgery

Intervention Type: PROCEDURE

Procedure / Surgery

Interventions

Procedure / Surgery

Procedure / Surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Suez Canal University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of dentistry - Suez Canal University

Ismailia, , Egypt

Countries

Egypt

Other Identifiers

723/2023

Identifier Type: -

Identifier Source: org_study_id