Unilateral Complete Cleft LipNAMNCT01883726
Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
A study testing Grayson's presurgical nasoalveolar molding and Figueroa's presurgical nasoalveolar molding in people with Unilateral Complete Cleft Lip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods. Read more about this study
- Who is it for?
- Ages 1 week to 3 months
- Conditions the study is for
- Unilateral Complete Cleft Lip
- What is being tested?
- Grayson's presurgical nasoalveolar molding and Figueroa's presurgical nasoalveolar molding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to Jul 2013
- 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 1 week to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Complete unilateral cleft lip infant
- Signed informed consent
Who cannot join
- Incomplete unilateral cleft lip infant
- Association of other craniofacial anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods.
Read the detailed description
Grayson's NAM reconstruction starts with alveolar molding first. The alveolar molding is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. After the alveolar cleft gap is less than 5 mm (usually at the end of second months), nasal molding was added to the alveolar molding plate.
Figueroa's NAM reconstruction use labial tapes and acrylic relief to the palatal plate to approximate alveolar gap. The device starts with nasal and alveolar molding simultaneously.
- Conditions
- Unilateral Complete Cleft Lip
- Being tested
- Grayson's presurgical nasoalveolar molding, Figueroa's presurgical nasoalveolar molding
- Keywords
- Unilateral complete cleft lip, Nasoalveolar molding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grayson's presurgical nasoalveolar moldingDevice
Grayson NAM
Figueroa's presurgical nasoalveolar moldingDevice
Figueroa NAM
| Study group | Role | What they receive |
|---|---|---|
| Grayson NAM | Experimental | Intervention: Grayson nasoalveolar molding This technique uses an acrylic plate to mold the alveolar segments and uses an extension to mold the alar cartilage of the nasal component. The construction is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. When the alveolar gap is reduced to 5 mm, nasal component are added to gradually mold the nasal cartilage and other nasal structures. Receives: Device: Grayson's presurgical nasoalveolar molding |
| Figueroa NAM | Experimental | Intervention: Figueroa's nasoalveolar molding Figueroa technique uses labial tapes and acrylic relief to the palatal plate to approximate alveolar gap [3]. The nasal component is added in the beginning of the treatment to mold the nasal cartilage. Receives: Device: Figueroa's presurgical nasoalveolar molding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nasal morphology - Nostril height 1
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Measured: (T1) at initial visit
The nasal morphology - Nostril height 2
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Measured: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - - Nostril height 3
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Measured: (T3) one week after surgery
The nasal morphology - Nostril height 4
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
Measured: (T4) 6 months after surgery
The nasal morphology - Nostril width 1
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Measured: (T1) at initial visit
The nasal morphology - Nostril width 2
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Measured: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - Nostril width 3
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Measured: (T3) one week after surgery
The nasal morphology - Nostril width 4
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
Measured: (T4) 6 months after surgery
The nasal morphology - Nasal sill height 3
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Measured: (T3) one week after surgery
The nasal morphology - Nasal sill height 4
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
Measured: (T4) 6 months after surgery
The nasal morphology - nostril area 1
Nostril area: the area presented by nostril aperture.
Measured: (T1) at initial visit
The nasal morphology - nostril area 2
Nostril area: the area presented by nostril aperture.
Measured: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
The nasal morphology - nostril area 3
Nostril area: the area presented by nostril aperture.
Measured: (T3) one week after surgery
The nasal morphology - nostril area 4
Nostril area: the area presented by nostril aperture.
Measured: (T4) 6 months after surgery
Secondary outcomes (4)
duration of NAM
Duration of NAM = Operation date - NAM initiation date
Measured: From initial of nasoalveolar molding to finish of nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
total number of visits before surgical correction
Total number of orthodontic visit or NAM adjustment = number of adjustment of NAM
Measured: From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age)
cost of treatment
Cost = cost of each visit of orthodontic and adjustment of NAM before surgery
Measured: From initial orthodontic visit to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
NAM complications
Any complication like mucosa ulceration and facial skin irritation
Measured: From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionJul 2013 (estimated)
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 Complete Cleft LipStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883726
- Sponsor's protocol ID
- 102-1267C
- Acronym
- NAM
- Status last verified
- Apr 2013
- First submitted
- 3 Jun 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang FC, Huang JJ, Wallace CG, Hsiao YC, Chen ZC, Liao YF, Chen PK. Comparison of Facial Growth between Two Nasoalveolar Molding Techniques in Patients with Unilateral Complete Cleft Lip. Plast Reconstr Surg. 2023 Nov 1;152(5):1078-1083. doi: 10.1097/PRS.0000000000010448. Epub 2023 Mar 21.
PubMed 36940137Chang CS, Wallace CG, Pai BC, Chiu YT, Hsieh YJ, Chen IJ, Liao YF, Liou EJ, Chen PK. Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes. Plast Reconstr Surg. 2014 Aug;134(2):275-282. doi: 10.1097/PRS.0000000000000361.
PubMed 24732649
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Nasoalveolar Molding Techniques in Complete Unilateral Cleft Lip Patient
- ClinicalTrials.gov ID
- NCT01883726
- Acronym / sponsor ID
- NAM / 102-1267C
- Conditions
- Unilateral Complete Cleft Lip
- Keywords
- Unilateral complete cleft lip, Nasoalveolar molding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (estimated)
- First posted
- 21 Jun 2013 (estimated)
- 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.
Two types of Presurgical Nasoalveolar Molding (NAM) coexist in Craniofacial Center in Chang Gung Memorial Hospital. The objective of this study is to compare the number of clinical visits, total prices, complications and nasal symmetry between these two NAM reconstruction methods.
Detailed description
Grayson's NAM reconstruction starts with alveolar molding first. The alveolar molding is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. After the alveolar cleft gap is less than 5 mm (usually at the end of second months), nasal molding was added to the alveolar molding plate.
Figueroa's NAM reconstruction use labial tapes and acrylic relief to the palatal plate to approximate alveolar gap. The device starts with nasal and alveolar molding simultaneously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grayson NAM | Experimental | Device: Grayson's presurgical nasoalveolar moldingIntervention: Grayson nasoalveolar molding This technique uses an acrylic plate to mold the alveolar segments and uses an extension to mold the alar cartilage of the nasal component. The construction is made by gradual modification of the acrylic plate with periodic acrylic add on and grinding. When the alveolar gap is reduced to 5 mm, nasal component are added to gradually mold the nasal cartilage and other nasal structures. |
| Figueroa NAM | Experimental | Device: Figueroa's presurgical nasoalveolar moldingIntervention: Figueroa's nasoalveolar molding Figueroa technique uses labial tapes and acrylic relief to the palatal plate to approximate alveolar gap [3]. The nasal component is added in the beginning of the treatment to mold the nasal cartilage. |
Who may qualify
- Ages
- 1 week to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Complete unilateral cleft lip infant
- Signed informed consent
Key exclusion criteria (2 listed)
- Incomplete unilateral cleft lip infant
- Association of other craniofacial anomalies
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 |
|---|---|---|
| Grayson's presurgical nasoalveolar moldingGrayson NAM | Device | Grayson NAM |
| Figueroa's presurgical nasoalveolar moldingFigueroa NAM | Device | Figueroa NAM |
Primary outcome
The nasal morphology - Nostril height 1
Time frame: (T1) at initial visit
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 2
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - - Nostril height 3
Time frame: (T3) one week after surgery
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril height 4
Time frame: (T4) 6 months after surgery
Nostril height: the vertical distance between horizontal reference lines to the highest point of nostril aperture.
The nasal morphology - Nostril width 1
Time frame: (T1) at initial visit
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 2
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 3
Time frame: (T3) one week after surgery
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nostril width 4
Time frame: (T4) 6 months after surgery
Nostril width: The widest horizontal distance between the inner medial and lateral border of nostril aperture.
The nasal morphology - Nasal sill height 3
Time frame: (T3) one week after surgery
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
The nasal morphology - Nasal sill height 4
Time frame: (T4) 6 months after surgery
Nasal sill height: the vertical distance between the horizontal reference line to the lowest border of nostril aperture.
The nasal morphology - nostril area 1
Time frame: (T1) at initial visit
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 2
Time frame: (T2) after nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 3
Time frame: (T3) one week after surgery
Nostril area: the area presented by nostril aperture.
The nasal morphology - nostril area 4
Time frame: (T4) 6 months after surgery
Nostril area: the area presented by nostril aperture.
4 secondary outcomes
duration of NAM
Time frame: From initial of nasoalveolar molding to finish of nasoalveolar molding (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
total number of visits before surgical correction
Time frame: From the initial visit to the date of surgery (participants' surgery will be performed on 3-month of age)
cost of treatment
Time frame: From initial orthodontic visit to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
NAM complications
Time frame: From initial of NAM to finish of NAM (participants' nasoalveolar molding will be finished before surgery, an expected average of 3-months old)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Derived from this study: PubMed 36940137Chang FC, Huang JJ, Wallace CG, Hsiao YC, Chen ZC, Liao YF, Chen PK. Comparison of Facial Growth between Two Nasoalveolar Molding Techniques in Patients with Unilateral Complete Cleft Lip. Plast Reconstr Surg. 2023 Nov 1;152(5):1078-1083. doi: 10.1097/PRS.0000000000010448. Epub 2023 Mar 21.
- Derived from this study: PubMed 24732649Chang CS, Wallace CG, Pai BC, Chiu YT, Hsieh YJ, Chen IJ, Liao YF, Liou EJ, Chen PK. Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes. Plast Reconstr Surg. 2014 Aug;134(2):275-282. doi: 10.1097/PRS.0000000000000361.
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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 Grayson's presurgical nasoalveolar molding and Figueroa's presurgical nasoalveolar molding in people with Unilateral Complete Cleft Lip, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 2 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 21 Jun 2013. 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 Taiwan. 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?
The nasal morphology - Nostril height 1 (time frame: (T1) at initial visit). The study lists 14 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 NCT01883726, 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 21 Jun 2013.