Unilateral Cleft LipNCT06637488
Using Customized Nasal Conformer in Correction of Cleft Nasal Deformity in Patients with Unilateral Cleft Lip
A study testing cleft lip repair using fisher technique in people with Unilateral Cleft Lip, run by Mahmoud Akram at 1 site in Egypt.
Trial summary
The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side . Read more about this study
- Who is it for?
- Ages 10 to 24 weeks
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- cleft lip repair using fisher technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Sep 2024
- 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 10 to 24 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of both sexes with unilateral cleft lip.
- Age range 10 - 24 weeks.
- Hemoglobin more than 10 gm/dl .
- Weight more than 10 lbs.
Who cannot join
- Syndromic patients.
- Patients with conditions contradicting operation.
- Patients with Bilateral cleft lip.
- Patients with previous surgeries in lip and nose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side .
- Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle.
- Evaluation of degree of similarity using esthetic scales at six months postoperative.
Participants will receive nasal conformers intraoperative with follow up of 6 months.
- Conditions
- Unilateral Cleft Lip
- Being tested
- cleft lip repair using fisher technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleft lip repair using fisher techniqueProcedure or surgery
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side
cleft lip repair using fisher techniqueProcedure or surgery
Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. No nasal conformers used in this group
| Study group | Role | What they receive |
|---|---|---|
| Unilateral cleft lip repair using customized nasal conformer | Experimental | Not described Receives: Procedure: cleft lip repair using fisher technique |
| Unilateral cleft lip repair without using customized nasal conformer | Active comparator | Not described Receives: Procedure: cleft lip repair using fisher technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nostril height
The greatest vertical distance of the nostril in millimeters .
Measured: 6 months
Nostril width
This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters.
Measured: 6 months
Columellar Deviation Angle
The midline columellar deviation from the vertical reference line was measured in degrees.
Measured: 6 months
Nasolabial Groove Angle
To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unilateral Cleft LipStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Akram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Akram, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637488
- Sponsor's protocol ID
- Nasal conformer in cleft lip
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial. BMC Oral Health. 2026 Apr 15;26(1):735. doi: 10.1186/s12903-026-08274-x.
PubMed 41987134Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial. Head Face Med. 2025 Aug 1;21(1):55. doi: 10.1186/s13005-025-00533-6.
PubMed 40751267
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
- ClinicalTrials.gov ID
- NCT06637488
- Acronym / sponsor ID
- Nasal conformer in cleft lip
- Conditions
- Unilateral Cleft Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mahmoud AkramUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 15 Oct 2024 (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.
The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side .
- Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle.
- Evaluation of degree of similarity using esthetic scales at six months postoperative.
Participants will receive nasal conformers intraoperative with follow up of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral cleft lip repair using customized nasal conformer | Experimental | Procedure: cleft lip repair using fisher technique |
| Unilateral cleft lip repair without using customized nasal conformer | Active comparator | Procedure: cleft lip repair using fisher technique |
Who may qualify
- Ages
- 10 to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients of both sexes with unilateral cleft lip.
- Age range 10 - 24 weeks.
- Hemoglobin more than 10 gm/dl .
- Weight more than 10 lbs.
Key exclusion criteria (4 listed)
- Syndromic patients.
- Patients with conditions contradicting operation.
- Patients with Bilateral cleft lip.
- Patients with previous surgeries in lip and nose.
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 |
|---|---|---|
| cleft lip repair using fisher techniqueDisinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side | Procedure or surgery | Unilateral cleft lip repair using customized nasal conformer |
| cleft lip repair using fisher techniqueDisinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. No nasal conformers used in this group | Procedure or surgery | Unilateral cleft lip repair without using customized nasal conformer |
Primary outcome
Nostril height
Time frame: 6 months
The greatest vertical distance of the nostril in millimeters .
Nostril width
Time frame: 6 months
This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters.
Columellar Deviation Angle
Time frame: 6 months
The midline columellar deviation from the vertical reference line was measured in degrees.
Nasolabial Groove Angle
Time frame: 6 months
To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees.
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 26 Oct 2024.
- Derived from this study: PubMed 41987134Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial. BMC Oral Health. 2026 Apr 15;26(1):735. doi: 10.1186/s12903-026-08274-x.
- Derived from this study: PubMed 40751267Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial. Head Face Med. 2025 Aug 1;21(1):55. doi: 10.1186/s13005-025-00533-6.
- Individual participant dataSharing planned: Undecided
Related trials for Unilateral Cleft Lip
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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 cleft lip repair using fisher technique in people with Unilateral Cleft Lip, run by Mahmoud Akram 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 4 inclusion and 4 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 26 Oct 2024. 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?
Nostril height (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06637488, which also lists 2 linked publications.
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 26 Oct 2024.