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Re-treatment of Cleft Lip and Nasal DeformationNCT07348185

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

A study testing Procedure / Surgery in people with Re-treatment of Cleft Lip and Nasal Deformation, run by Suez Canal University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 8 to 30 yearsHealthy volunteers can take part
What is being tested?
Procedure / Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteEgypt
Study dates
1 Sep 2023to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of dentistry - Suez Canal University

    Ismailia

Other trials in Egypt

About this study

Official title: 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

Read the 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.

Being tested
Procedure / Surgery
Keywords
Secondary repair of Cleft Lip and Nasal Deformation, Clinical Evaluation, Cleft Q Scale, Photographic Evaluation for Lip and Nose, Radiographic assessment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Procedure / SurgeryProcedure or surgery

    Procedure / Surgery

Study groups in NCT07348185
Study groupRoleWhat they receive
Twenty five patients who will have a secondary repair for cleft lip or nasal deformities.OtherTwenty five patients who will have a secondary repair for cleft lip or nasal deformities.
Receives: Procedure: Procedure / Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CLEFT-Q

    • 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.

    Measured: Postoperative follow-up every week for 1 month, then after 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start1 Sep 2023
  3. Primary completion1 Sep 2024
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
The study was conducted after the approval of the Research Ethics Committee (REC) of the Faculty of Dentistry, Suez Canal University. It was conducted on twenty five patients who will have a secondary repair for cleft lip or nasal deformities.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07348185
Sponsor's protocol ID
723/2023
Status last verified
Dec 2025
First submitted
8 Jan 2026
Last updated
16 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Procedure / Surgery in people with Re-treatment of Cleft Lip and Nasal Deformation, run by Suez Canal University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CLEFT-Q (time frame: Postoperative follow-up every week for 1 month, then after 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.

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