Unilateral Cleft LipNCT07850180
Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery
A study testing customized nostril retainer in people with Unilateral Cleft Lip, run by Hanoi Medical University.
Trial summary
The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose… Read more about this study
- Who is it for?
- Ages 3 to 18 months
- Conditions the study is for
- Unilateral Cleft Lip
- What is being tested?
- customized nostril retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.
- No local infection or inflammation.
- No associated congenital anomalies other than cleft lip and/or cleft palate.
Who cannot join
- Participants who do not meet any one of the inclusion criteria.
- Patients who are unable to attend follow-up visits.
- Families or legal guardians who refuse to participate in the study.
About this study
The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose in children following unilateral cleft lip repair?
The researchers will compare the use and non-use of a customized nostril retainer to determine whether the retainer is effective in supporting the aesthetic reconstruction of the nose.
Read more
Participants will be divided into two groups (the intervention group and the control group):
Study population: Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.
Intervention group: Participants who use a customized nostril retainer after unilateral cleft lip repair.
Control group: Participants who do not use a customized nostril retainer after unilateral cleft lip repair.
Follow-up: Participants will return for follow-up visits at 1 week, 3 months, and 6 months after surgery.
Outcome assessment: Nasal aesthetics will be evaluated at each follow-up visit, along with the convenience and ease of use of the retainer, assessed through interviews with caregivers.
- Conditions
- Unilateral Cleft Lip
- Being tested
- customized nostril retainer
- Keywords
- unilateral cleft lip, customized nostril retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customized nostril retainerDevice
Participants will undergo unilateral cleft lip repair and will then be assigned to either receive or not receive a customized nostril retainer.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: customized nostril retainer | Experimental | Participants who use a customized nostril retainer after unilateral cleft lip repair. Receives: Device: customized nostril retainer |
| Control arm - Non-customized nostril retainer | No intervention | Participants who do not use a customized nostril retainer after unilateral cleft lip repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-intervention nasal symmetry
Columellar deviation: This measure is assessed by the angle formed between the tangent line passing through the nasal base and the line passing through the midpoint of the columella. The value ranges from 0° to 90°, with a larger angle indicating a better outcome.
Degree of alar collapse on the affected side compared with the unaffected side: This measure is assessed as the ratio of the alar height on the affected side to the alar height on the unaffected side. The value ranges from 0% to 100%, with a higher ratio indicating a better outcome.
Measured: at 1 week, 3 months, and 6 months postoperatively
Secondary outcomes (1)
convenience and ease of use of the retainer
Adverse effects: This variable determines the presence or absence of adverse effects associated with the use of the device (e.g., whether the child is irritable or fussy, and whether there is redness or an inflammatory reaction at the device-skin contact area).
Convenience and satisfaction: Scores are rated on a 1-5 scale, corresponding to very dissatisfied - dissatisfied - neutral - satisfied - very satisfied, respectively. A higher score indicates greater convenience and satisfaction.
Measured: at 1 week, 3 months, and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinh Dieu Hong, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850180
- Sponsor's protocol ID
- 972050.1789
- Status last verified
- Feb 2026
- First submitted
- 17 Sep 2026
- Last updated
- 30 Sep 2026
- 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 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Supportive Effect of Personalized Nostril Retainer in Unilateral Cleft Lip Surgery
- ClinicalTrials.gov ID
- NCT07850180
- Acronym / sponsor ID
- 972050.1789
- Conditions
- Unilateral Cleft Lip
- Keywords
- unilateral cleft lip, customized nostril retainer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 30 Sep 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.
The objective of this clinical trial is to evaluate the supportive effectiveness of a customized nostril retainer in unilateral cleft lip repair at several hospitals in Hanoi. The main question that this trial aims to answer is: Does a customized nostril retainer help improve the aesthetic reconstruction of the nose in children following unilateral cleft lip repair?
The researchers will compare the use and non-use of a customized nostril retainer to determine whether the retainer is effective in supporting the aesthetic reconstruction of the nose.
Participants will be divided into two groups (the intervention group and the control group):
Study population: Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.
Intervention group: Participants who use a customized nostril retainer after unilateral cleft lip repair.
Control group: Participants who do not use a customized nostril retainer after unilateral cleft lip repair.
Follow-up: Participants will return for follow-up visits at 1 week, 3 months, and 6 months after surgery.
Outcome assessment: Nasal aesthetics will be evaluated at each follow-up visit, along with the convenience and ease of use of the retainer, assessed through interviews with caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm: customized nostril retainer | Experimental | Device: customized nostril retainerParticipants who use a customized nostril retainer after unilateral cleft lip repair. |
| Control arm - Non-customized nostril retainer | No intervention | –Participants who do not use a customized nostril retainer after unilateral cleft lip repair |
Who may qualify
- Ages
- 3 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients younger than 18 months with unilateral cleft lip who undergo primary lip and nasal repair.
- No local infection or inflammation.
- No associated congenital anomalies other than cleft lip and/or cleft palate.
Key exclusion criteria (3 listed)
- Participants who do not meet any one of the inclusion criteria.
- Patients who are unable to attend follow-up visits.
- Families or legal guardians who refuse to participate in the study.
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 |
|---|---|---|
| customized nostril retainerParticipants will undergo unilateral cleft lip repair and will then be assigned to either receive or not receive a customized nostril retainer. | Device | Intervention arm: customized nostril retainer |
Primary outcome
Post-intervention nasal symmetry
Time frame: at 1 week, 3 months, and 6 months postoperatively
Columellar deviation: This measure is assessed by the angle formed between the tangent line passing through the nasal base and the line passing through the midpoint of the columella. The value ranges from 0° to 90°, with a larger angle indicating a better outcome. Degree of alar collapse on the affected side compared with the unaffected side: This measure is assessed as the ratio of the alar height on the affected side to the alar height on the unaffected side. The value ranges from 0% to 100%, with a higher ratio indicating a better outcome.
1 secondary outcome
convenience and ease of use of the retainer
Time frame: at 1 week, 3 months, and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing customized nostril retainer in people with Unilateral Cleft Lip, run by Hanoi Medical University.
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 3 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Post-intervention nasal symmetry (time frame: at 1 week, 3 months, and 6 months postoperatively). 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 30 Sep 2026.