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.
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
- Conditions the study is for
- Re-treatment of Cleft Lip and Nasal Deformation
- 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.
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 group | Role | What they receive |
|---|---|---|
| Twenty five patients who will have a secondary repair for cleft lip or nasal deformities. | Other | Twenty 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.
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.
- First posted16 Jan 2026
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Re-treatment of Cleft Lip and Nasal DeformationStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Re-treatment of Cleft Lip and Nasal Deformation in Patients With Post Repair Deformities. A Single Group Study
- ClinicalTrials.gov ID
- NCT07348185
- Acronym / sponsor ID
- 723/2023
- Keywords
- Secondary repair of Cleft Lip and Nasal Deformation, Clinical Evaluation, Cleft Q Scale, Photographic Evaluation for Lip and Nose, Radiographic assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Twenty five patients who will have a secondary repair for cleft lip or nasal deformities. | Other | Procedure: Procedure / SurgeryTwenty five patients who will have a secondary repair for cleft lip or nasal deformities. |
Who may qualify
- Ages
- 8 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure / SurgeryProcedure / Surgery | Procedure or surgery | Twenty five patients who will have a secondary repair for cleft lip or nasal deformities. |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.