Cleft LipNCT04627389
Orbicularis Oris Z-plasty Modification of Modified Millard Technique and the Esthetic Outcome of Cleft Lip Repair
A study testing orbicularis oris muscle Z- plasty modification of modified millard technique and modified millard technique in people with Cleft Lip, run by Fayoum University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Cleft Lip
- What is being tested?
- orbicularis oris muscle Z- plasty modification of modified millard technique and modified millard technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 1 Jun 2023
- 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 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- non-syndromic cleft lip patients.
- Primary, unilateral, complete or incomplete cleft lip.
- The patient's age is younger than six months.
- lip repair performed by one craniofacial surgeon
Who cannot join
- syndromic cleft lip.
- Secondary lip treatment (previously operated cases)
- Bilateral cleft lip
- Patients are older than six months. Associated Cardiac anomalies. Any systemic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Esthetic Outcomes Evaluation of Unilateral Cleft Lip Repaired by Orbicularis Oris Z-plasty Modification of Modified Millard Technique Versus Modified Millard Technique. A Randomized Clinical Trail.
This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip
Read the detailed description
forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).
- Conditions
- Cleft Lip
- Being tested
- orbicularis oris muscle Z- plasty modification of modified millard technique, modified millard technique
- Keywords
- cleft lip, chelioplasty, modified millard, orbicularis oris modification
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orbicularis oris muscle Z- plasty modification of modified millard techniqueProcedure or surgery
After orbicularis oris muscle had been released from the overlying skin, the previously marked points using methylene blue for designing the z-plasty were shown to be followed by back-cut incisions including the OOM and inner mucosa in both medial and lateral elements without involving the overlying skin. This procedure resulted in two triangular flaps in both segments
modified millard techniqueProcedure or surgery
no z-plasty modification
| Study group | Role | What they receive |
|---|---|---|
| study arm | Experimental | 20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique Receives: Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique |
| controlled arm | Active comparator | 20 patients with a unilateral cleft lip will be repaired with modified Millard technique Receives: Procedure: modified millard technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
lip legth
evaluate the lip length of the cleft side changes from preoperative at immediate postoperative
Measured: immediate postoperative
Secondary outcomes (4)
Philtral ridge length symmetry index assessment
Philtral ridge symmetry index was calculated as follow:- (philtral ridge length by mm at cleft side)/(philtral ridge length by mm at non-clefted side)×100
Measured: 6months
Scar width assessment by photograph
Standard photography was taken; objective measurements were obtained from the photographs using the ruler as a control reference.
One standard surgical ruler was placed over the lower lip and a frontally orientated photograph of the patient was taken at 6m follow up to assess scar width using the Image J1.5i0R program. The first point was 1mm above the white roll and the second point was 1mm below the C-flap suture line . Scar width will be measured by two assessors and the mean score of two assessors was calculated
Measured: 6months
scar width by ultrasound
scar width will be quantified by ultrasound. The transducer placement with its upper border touching the columella-philtral junction, upper lip imaging obtained and the scar width will be measured.
Measured: 6months
scar elascitity
Scar elasticity will be quantified by ultrasound. The transducer, coupled with several millimeters of ultrasound gel, was smoothly placed in the longitudinal section and perpendicular to the skin without compressing the tissue. Compare scar stiffness in relation to adjacent normal tissue
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Oct 2020
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
- Investigators
- shaimaa refahee, phd, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627389
- Sponsor's protocol ID
- 27/9/20
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esthetic Outcomes Evaluation of Unilateral Cleft Lip Repaired by Orbicularis Oris Z-plasty Modification of Modified Millard Technique Versus Modified Millard Technique. A Randomized Clinical Trail.
- ClinicalTrials.gov ID
- NCT04627389
- Acronym / sponsor ID
- 27/9/20
- Conditions
- Cleft Lip
- Keywords
- cleft lip, chelioplasty, modified millard, orbicularis oris modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 13 Nov 2020 (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.
This study aimed to evaluate the effect of orbicularis oris muscle z-plasty modification of modified Millard technique on the esthetic outcome and length of the repaired lip
Detailed description
forty patients with a unilateral cleft lip will be enrolled in this randomized comparative study. The patients will be divided into two groups, the control (group A) who treated with the modified Millard technique and the study group who repaired by orbicularis oris muscle Zplasty modification of modified Millard technique (group B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study arm | Experimental | Procedure: orbicularis oris muscle Z- plasty modification of modified millard technique20 patients with a unilateral cleft lip will be repaired with orbicularis oris muscle Z-plasty modification of modified Millard technique |
| controlled arm | Active comparator | Procedure: modified millard technique20 patients with a unilateral cleft lip will be repaired with modified Millard technique |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- non-syndromic cleft lip patients.
- Primary, unilateral, complete or incomplete cleft lip.
- The patient's age is younger than six months.
- lip repair performed by one craniofacial surgeon
Key exclusion criteria (4 listed)
- syndromic cleft lip.
- Secondary lip treatment (previously operated cases)
- Bilateral cleft lip
- Patients are older than six months. Associated Cardiac anomalies. Any systemic condition
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 |
|---|---|---|
| orbicularis oris muscle Z- plasty modification of modified millard techniqueAfter orbicularis oris muscle had been released from the overlying skin, the previously marked points using methylene blue for designing the z-plasty were shown to be followed by back-cut incisions including the OOM and inner mucosa in both medial and lateral elements without involving the overlying skin. This procedure resulted in two triangular flaps in both segments | Procedure or surgery | study arm |
| modified millard techniqueno z-plasty modification | Procedure or surgery | controlled arm |
Primary outcome
lip legth
Time frame: immediate postoperative
evaluate the lip length of the cleft side changes from preoperative at immediate postoperative
4 secondary outcomes
Philtral ridge length symmetry index assessment
Time frame: 6months
Scar width assessment by photograph
Time frame: 6months
scar width by ultrasound
Time frame: 6months
scar elascitity
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Individual participant dataSharing planned: No
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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.
shaimaa refahee, phd principal investigator
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orbicularis oris muscle Z- plasty modification of modified millard technique and modified millard technique in people with Cleft Lip, run by Fayoum 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 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: status not confirmed, as of the sponsor's last update on 12 Oct 2022. 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?
Results are not available in the source record.
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?
lip legth (time frame: immediate postoperative). 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 12 Oct 2022.