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| ID | Type | Description | Link |
|---|---|---|---|
| ChangGungMH | Other Identifier | ChangGungMH |
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study hypothesis
The aim of this study:
How can the investigators predict and control the nasal changes after maxillary LeFort I osteotomy with 2 different alar base suture techniques ?
Study hypothesis
Background and study purpose:
Patients who received maxillary LeFort I osteotomy often complained about their nose become wider and more nostril show after surgery. According the the literature review, the conventional and modified alar base cinch technique both could control the interalar width. However, there is no long term result show which technique is superior to the other. Therefore, in order to improve patients' nasal and midfacial esthetics after the surgery, this study is to evaluate how the nasal changes affected by 2 different alar base cinch suture and which technique could result in a more positive effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified alar base cinch suture | Active Comparator | Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The modified alar cinch suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. |
|
| conventional alar base cinch suture | Placebo Comparator | Before closure of the maxillary wound, an alar base cinch suture was performed with 3-O Nylon. The conventional alar base cinch suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional alar base cinch | Procedure | The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine. |
| Measure | Description | Time Frame |
|---|---|---|
| Soft and Hard Tissue Landmarks Movement | The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy. The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery. | The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 14 Nasolabial Linear Parameters |
| up to post-operation 6 months |
| 1 Nasolabial Angular Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen, Wen Ching Ko, DDS,MS | Chang Gung MH | Study Director |
| YiHsuan Chen, DDS, MS | Chang Gung MH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung memorial hospital | Taipei | Taiwan | 333 | Taiwan |
Exclusion criteria: Patients with an associated syndromic diagnosis, cleft of the lip or palate, dentofacial trauma, and previous nasal septum or nasal tip operations. 10 non-Class III patients were further excluded for enhanced sample consistency, 2 patients refused to participate were also excluded. Thus, total sample size was 48 patients.
All nongrowing Taiwanese patients over 18 years of age who underwent LeFort I maxillary osteotomy to correct skeletal discrepancies were randomly selected to receive either conventional or modified alar base cinching during the intraoral wound closing procedure.The recruitment duration was September of 2011 to February of 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Alar Cinch Group | Patients received conventional alar base cinch technique during LeFort I osteotomy procedure. |
| FG001 | Modified Alar Cinch Group | Patients received modified alar base cinch technique during LeFort I osteotomy procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Taiwanese Class III patients
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Alar Cinch Suture | modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Soft and Hard Tissue Landmarks Movement | The investigator measured the movement (1 month minus baseline) of hard tissue landmarks before and after 4-6 weeks maxillary LeFort I osteotomy. The movement (6 months minus baseline) of soft tissue landmarks was measured before and after 6 months of the maxillary LeFort I osteotomy. The 3D directional movement of each point was measured in the x(transverse), y(vertical), and z (antero-posterior)planes. The positive directional movement of each point in X axis means the point moved left after surgery, and negative directional movement in X axis means the the point moved right after surgery. The positive directional movement in Y axis means the point moved upward after surgery, and negative directional movement in Y axis means the the point moved downward after surgery. The positive directional movement in Z axis means the point moved anteriorly after surgery, and negative directional movement in Z axis means the the point moved posteriorly after surgery. | similar sex distribution in both groups (7 male and 17 female patients in Group C, and 8 male and 16 female patients in Group M) | Posted | Mean | Standard Deviation | mm | The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months. |
6 months after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Alar Cinch Suture | modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base. modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yi Hsuan Chen | ChangGungMH | +886227135211 | 3533 | acantehr@gmail.com |
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|
| modified alar base cinch | Procedure | The modified suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine. |
|
|
2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)
| up to post-operation 6 months |
| Conventional Alar Base Cinch Suture |
conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Modified Alar Cinch Suture | modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy. |
| OG001 | Conventional Alar Base Cinch Suture | conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy. |
|
|
|
| Secondary | 14 Nasolabial Linear Parameters |
| Posted | Mean | Standard Deviation | mm | up to post-operation 6 months |
|
|
|
|
| Secondary | 1 Nasolabial Angular Parameters | 2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®) | Posted | Mean | Standard Deviation | degree | up to post-operation 6 months |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Conventional Alar Base Cinch Suture | conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy. | 0 | 24 | 0 | 24 |
no financial PI disclosure
| nasal length change |
|
| nasal tip protrusion change |
|
| Nasal width change |
|
| Alar base width change |
|
| R nostril show vertical dimension change |
|
| L nostril show vertical dimension |
|
| Columellar length change |
|
| Cutaneous height of upper lip change |
|
| Overall upper lip height change |
|
| Vermilion height of upper lip change |
|
| Lower prolabial width change |
|
| Upper lip protrusion change |
|
P- value < 0.05 was set as statistical significance. |
| 0.336 |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | P- value < 0.05 was set as statistical significance | 0.192 | 2-Sided | No | Superiority or Other |
| nasal tip protrusion | t-test, 2 sided | P value < 0.05 was set as statistical significance. | 0.135 | 2-Sided | No | Superiority or Other |
| nasal width | t-test, 2 sided | P value < 0.05 was set as statistical significance. | 0.277 | 2-Sided | No | Superiority or Other |
| alar base width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.505 | 2-Sided | No | Superiority or Other |
| R nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.299 | 2-Sided | No | Superiority or Other |
| L nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.738 | 2-Sided | No | Superiority or Other |
| columellar length | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.008 | 2-Sided | No | Superiority or Other |
| cutaneious height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.116 | 2-Sided | No | Superiority or Other |
| overall upper lip height | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.528 | 2-Sided | No | Superiority or Other |
| vermillion height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.123 | 2-Sided | No | Superiority or Other |
| lower prolabial width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.250 | 2-Sided | No | Superiority or Other |
| upper lip protrusion | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.706 | 2-Sided | No | Superiority or Other |
| intercanthal distance | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.804 | 2-Sided | No | Superiority or Other |
| nasal height | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.114 | 2-Sided | No | Superiority or Other |
| Nasal length | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.457 | 2-Sided | No | Superiority or Other |
| Nasal tip protrusion | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.565 | 2-Sided | No | Superiority or Other |
| nasal width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.781 | 2-Sided | No | Superiority or Other |
| alar base width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.164 | 2-Sided | No | Superiority or Other |
| R nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.554 | 2-Sided | No | Superiority or Other |
| L nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.508 | 2-Sided | No | Superiority or Other |
| columellar length | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.358 | 2-Sided | No | Superiority or Other |
| cutaneous height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.049 | 2-Sided | No | Superiority or Other |
| overall upper lip height | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.057 | 2-Sided | No | Superiority or Other |
| vermillion height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.062 | 2-Sided | No | Superiority or Other |
| lower prolabial width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.029 | 2-Sided | No | Superiority or Other |
| upper lip protrusion | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.011 | 2-Sided | No | Superiority or Other |
| intercanthal distance | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.211 | 2-Sided | No | Superiority or Other |
| nasal height | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.102 | 2-Sided | No | Superiority or Other |
| nasal length | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.136 | 2-Sided | No | Superiority or Other |
| nasal tip protrusion | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.113 | 2-Sided | No | Superiority or Other |
| nasal width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.115 | 2-Sided | No | Superiority or Other |
| alar base width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.535 | 2-Sided | No | Superiority or Other |
| R nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.850 | 2-Sided | No | Superiority or Other |
| L nostril show vertical dimension | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.891 | 2-Sided | No | Superiority or Other |
| columellar length | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.262 | 2-Sided | No | Superiority or Other |
| cutaneous height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.344 | 2-Sided | No | Superiority or Other |
| overall upper lip height | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.057 | 2-Sided | No | Superiority or Other |
| vermillion height of upper lip | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.995 | 2-Sided | No | Superiority or Other |
| lower prolabial width | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.440 | 2-Sided | No | Superiority or Other |
| upper lip protrusion | t-test, 2 sided | P-value < 0.05 was set as statistical significance(*). | 0.078 | 2-Sided | No | Superiority or Other |
P value <0.05 was set as statistical significance. |
| 0.043 |
Intergroup difference of modified group |
| 2-Sided |
| No |
| Superiority or Other |
| t-test, 2 sided | P value < 0.05 was set as statistical significance. | 0.888 | 2-Sided | No | Superiority or Other |