Cleft LipNCT05748340
Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique
A study testing Unilateral cleft lip repair in people with Cleft Lip, run by Cairo University at 1 site in Egypt.
Trial summary
Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group… 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?
- Unilateral cleft lip repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 Sep 2022
- 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
- Infants with unilateral isolated cleft lip aged from 2-6 months
- Infants with incomplete and complete unilateral cleft lip(reach floor of the nose)
Who cannot join
- Infants less than 2 months or more than 6 months
- Bilateral cleft lip patients
- Recurrent repair cleft lip cases
- Facial cleft cases 5-Syndromic patients cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Modified Millard and Mishra Technique in Unilateral Cleft Lip Repair: a Randomised Controlled Study
Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group deformity was more severe. The lip shape, the vermilion shape was better in Millard technique than Mishra technique, however, this was statistically insignificant The scar shape was less evident in Mishra technique than Millard technique. But this was also statistically insignificant. However, no major difference in the overall results between the Mishra and Millard rotationadvancement repairs. Thus, either technique could be used for unilateral clefts, as the goal of cleft lip repair is making a symmetrical lip with minimal scar restoring the normal appearance of the face and functional anatomy Anthropometric Measurement of surgical outcome evaluates the surgical technique used and helps to compare between cleft and non-cleft side showing the degree of deformity and we used Subjective assessment to analyse facial aesthetics and appearance impairment as the harmony of a person's face is as Important as measurements, so they should be used together in our opinion.
Read the detailed description
Cleft lip and palate, which affects 0.5-1.6 out of every 1000 live births, is the most prevalent congenital defect of the head and neck .
When the palatal shelves and the medial nasal process fail to fuse together between the fourth and eighth weeks of development, unilateral cleft lip and palate results . Lip muscles are disrupted and abnormally inserted to the columellar base on the non-cleft side and from the alar base on the cleft side. The nasal floor and alveolus on the cleft side may be deficient or absent. Several approaches, including quadrangular flaps, triangular flaps, and rotationadvancement procedures, were established in the middle of the twentieth century White Roll Vermilion Turn Down Flap (WRV flap) from the lateral lip element Making a symmetrical lip with a small scar and restoring the face's natural appearance and functional structure are the objectives of cleft lip repair . Over the past century, numerous surgical repair approaches have been developed The first known cleft-lip repair was a straight-line suture and a simple cut along the cleft borders, followed by a curved incision to lengthen the lip Drawbacks of straight-line restorations included vertical scar contracture and lip notching Tennison-triangular Randall's approach, which relies on mathematical calculations and lessens vertical lip contraction, is the most popular triangular technique, however the scar violates the philtrum.The Millard rotation-advancement approach was created to align the scar with the philtral column naturally occurring. The initial rotation-advancement technique underwent various variations. Vermilion notching and a scar along the philtral line can be noticed in Millard's repair. The Cupid's bow is distorted and the white roll up is pulled up by scar contracture. was employed by Mishra to modify Millard's technique to create the vermilion and white roll on the medial lip segment. If there is medial hypoplastic vermilion or partial medial vermilion loss, the Mishra procedure is also used Anthropometric Evaluation of surgical technique and comparison of cleft and non-cleft sides are two benefits of measuring surgical outcome .Farkas and colleagues, provided normative measurements of the lip and nose. Qualitative Assessment is subjective assessment and can analyze facial aesthetics and appearance impairment using scales, indices, scoring systems, and rankings. Both direct and indirect techniques can be used to perform anthropometric measurements and qualitative assessments. The most accurate anthropometric method is direct anthropometry, which is the gold standard but requires general anesthesia in young kids. Two dimensional (2D) images can be used for indirect anthropometry; however, calibration and image distance standardization are needed for linear measurements.
- Conditions
- Cleft Lip
- Being tested
- Unilateral cleft lip repair
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral cleft lip repairProcedure or surgery
Surgical repair unilateral cleft lip
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 21normal infant aged 3-6 months Receives: Procedure: Unilateral cleft lip repair |
| Group a | Other | 21 patient of unilateral cleft lip had mishra technique repair Receives: Procedure: Unilateral cleft lip repair |
| Group b | Other | 21 patient of unilateral cleft lip had modified Millard technique repair Receives: Procedure: Unilateral cleft lip repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical repair unilateral cleft lip measurements
- Vertical lip height
- Horizontal lip length
- Philtral length
Measured: At 3 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Apr 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
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 Cairo 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Salah Ahmed, Cairo University
- Investigators
- Kasr Elainy, Principal investigator, Cairo university Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748340
- Sponsor's protocol ID
- MD-40-2021
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Shared for every one
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Modified Millard and Mishra Technique in Unilateral Cleft Lip Repair: a Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT05748340
- Acronym / sponsor ID
- MD-40-2021
- Conditions
- Cleft Lip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 28 Feb 2023 (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.
Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group deformity was more severe. The lip shape, the vermilion shape was better in Millard technique than Mishra technique, however, this was statistically insignificant The scar shape was less evident in Mishra technique than Millard technique. But this was also statistically insignificant. However, no major difference in the overall results between the Mishra and Millard rotationadvancement repairs. Thus, either technique could be used for unilateral clefts, as the goal of cleft lip repair is making a symmetrical lip with minimal scar restoring the normal appearance of the face and functional anatomy Anthropometric Measurement of surgical outcome evaluates the surgical technique used and helps to compare between cleft and non-cleft side showing the degree of deformity and we used Subjective assessment to analyse facial aesthetics and appearance impairment as the harmony of a person's face is as Important as measurements, so they should be used together in our opinion.
Detailed description
Cleft lip and palate, which affects 0.5-1.6 out of every 1000 live births, is the most prevalent congenital defect of the head and neck .
When the palatal shelves and the medial nasal process fail to fuse together between the fourth and eighth weeks of development, unilateral cleft lip and palate results . Lip muscles are disrupted and abnormally inserted to the columellar base on the non-cleft side and from the alar base on the cleft side. The nasal floor and alveolus on the cleft side may be deficient or absent. Several approaches, including quadrangular flaps, triangular flaps, and rotationadvancement procedures, were established in the middle of the twentieth century White Roll Vermilion Turn Down Flap (WRV flap) from the lateral lip element Making a symmetrical lip with a small scar and restoring the face's natural appearance and functional structure are the objectives of cleft lip repair . Over the past century, numerous surgical repair approaches have been developed The first known cleft-lip repair was a straight-line suture and a simple cut along the cleft borders, followed by a curved incision to lengthen the lip Drawbacks of straight-line restorations included vertical scar contracture and lip notching Tennison-triangular Randall's approach, which relies on mathematical calculations and lessens vertical lip contraction, is the most popular triangular technique, however the scar violates the philtrum.The Millard rotation-advancement approach was created to align the scar with the philtral column naturally occurring. The initial rotation-advancement technique underwent various variations. Vermilion notching and a scar along the philtral line can be noticed in Millard's repair. The Cupid's bow is distorted and the white roll up is pulled up by scar contracture. was employed by Mishra to modify Millard's technique to create the vermilion and white roll on the medial lip segment. If there is medial hypoplastic vermilion or partial medial vermilion loss, the Mishra procedure is also used Anthropometric Evaluation of surgical technique and comparison of cleft and non-cleft sides are two benefits of measuring surgical outcome .Farkas and colleagues, provided normative measurements of the lip and nose. Qualitative Assessment is subjective assessment and can analyze facial aesthetics and appearance impairment using scales, indices, scoring systems, and rankings. Both direct and indirect techniques can be used to perform anthropometric measurements and qualitative assessments. The most accurate anthropometric method is direct anthropometry, which is the gold standard but requires general anesthesia in young kids. Two dimensional (2D) images can be used for indirect anthropometry; however, calibration and image distance standardization are needed for linear measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Procedure: Unilateral cleft lip repair21normal infant aged 3-6 months |
| Group a | Other | Procedure: Unilateral cleft lip repair21 patient of unilateral cleft lip had mishra technique repair |
| Group b | Other | Procedure: Unilateral cleft lip repair21 patient of unilateral cleft lip had modified Millard technique repair |
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants with unilateral isolated cleft lip aged from 2-6 months
- Infants with incomplete and complete unilateral cleft lip(reach floor of the nose)
Key exclusion criteria (4 listed)
- Infants less than 2 months or more than 6 months
- Bilateral cleft lip patients
- Recurrent repair cleft lip cases
- Facial cleft cases 5-Syndromic patients cases
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 |
|---|---|---|
| Unilateral cleft lip repairSurgical repair unilateral cleft lip | Procedure or surgery | Control group, Group a, Group b |
Primary outcome
Surgical repair unilateral cleft lip measurements
Time frame: At 3 months post operative
1. Vertical lip height 2. Horizontal lip length 3. Philtral length
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 28 Feb 2023.
- Individual participant dataSharing planned: Yes. Shared for every one
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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.
Kasr Elainy principal investigator
Cairo university Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral cleft lip repair in people with Cleft Lip, run by Cairo 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 2 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 28 Feb 2023. 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?
Surgical repair unilateral cleft lip measurements (time frame: At 3 months post operative). 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 28 Feb 2023.