Conditions in T74.31 or T76.31
Conditions
Keywords
Alar Base Suture; Nasolabial Change; 3D stereogrammetry
Brief summary
study hypothesis 1. 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 ? 2. Study hypothesis * Null hypothesis: Nasal changes were not affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy * Alternative : Nasal changes were affected by 2 different alar base suture techniques after maxillary LeFort I osteotomy
Detailed description
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.
Interventions
PROCEDUREconventional alar base cinch
The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.
PROCEDUREmodified alar base cinch
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Taiwanese patients who received LeFort I osteotomy at CGMH during 2011-2012 * No previous craniofacial surgery * Patients agreed to attend this study and willing to sign the agreement * Patients who are elder than 18 years old and after growth completion
Exclusion criteria
* Craniofacial anomalies * cleft lip and /or palate patients * patients without all the documents * patients do not receive combined correcting nasolabial shape and orthognathic surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Soft and Hard Tissue Landmarks Movement | The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 14 Nasolabial Linear Parameters | up to post-operation 6 months | 1. baseline characteristics: intercanthulus distance 2. nasal linear parameters 3. nasolabial linear parameters |
| 1 Nasolabial Angular Parameters | up to post-operation 6 months | 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®) |
Countries
Taiwan
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Conventional Alar Base Cinch Suture | Total | Modified Alar Cinch Suture |
|---|---|---|---|
| Age, Customized Age | 23.78 years | 23.92 years | 24.13 years |
| Race/Ethnicity, Customized Taiwanese | 24 participants | 48 participants | 24 participants |
| Region of Enrollment Taiwan | 24 participants | 48 participants | 24 participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 |
Outcome results
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.
Time frame: The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale X axis | -0.35 mm | Standard Deviation 1.7 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point Y axis | -1.58 mm | Standard Deviation 1.95 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale Y axis | -0.29 mm | Standard Deviation 1.42 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point Z axis | 0.50 mm | Standard Deviation 2.35 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale Z axis | 0.48 mm | Standard Deviation 1.04 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point Z axis | 1.11 mm | Standard Deviation 2.43 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale X axis | -0.67 mm | Standard Deviation 1.88 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point Y axis | -0.95 mm | Standard Deviation 2.1 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale Y axis | -0.62 mm | Standard Deviation 1.32 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level X axis | -0.86 mm | Standard Deviation 1.53 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale Z axis | 1.08 mm | Standard Deviation 1.89 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point X axis | 0.22 mm | Standard Deviation 1.5 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious X axis | -0.74 mm | Standard Deviation 2.02 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level Y axis | -1.08 mm | Standard Deviation 1.82 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious Y axis | -0.03 mm | Standard Deviation 2.09 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level Z axis | 2.42 mm | Standard Deviation 3.95 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious Z axis | -0.03 mm | Standard Deviation 2.09 |
| Modified Alar Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point X axis | 0.95 mm | Standard Deviation 1.29 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious Z axis | 0.42 mm | Standard Deviation 2.06 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point X axis | -0.5 mm | Standard Deviation 1.09 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point Y axis | -0.32 mm | Standard Deviation 2.82 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | ANS point Z axis | -0.71 mm | Standard Deviation 2.73 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point X axis | -0.58 mm | Standard Deviation 1.22 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point Y axis | -0.95 mm | Standard Deviation 2.29 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | A point Z axis | 1.83 mm | Standard Deviation 2.97 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level X axis | 0.30 mm | Standard Deviation 1.44 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level Z axis | 1.91 mm | Standard Deviation 2.88 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale X axis | 0.14 mm | Standard Deviation 1.23 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale Y axis | -0.12 mm | Standard Deviation 1.62 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | pronasale Z axis | 0.08 mm | Standard Deviation 1.43 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale X axis | 0.05 mm | Standard Deviation 1.13 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale Y axis | 0.21 mm | Standard Deviation 0.97 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | subnasale Z axis | -0.03 mm | Standard Deviation 1.55 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious X axis | 0.00 mm | Standard Deviation 1.64 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | labiale suprious Y axis | -0.90 mm | Standard Deviation 1.78 |
| Conventional Alar Base Cinch Suture | Soft and Hard Tissue Landmarks Movement | UI level Y axis | -0.58 mm | Standard Deviation 2.4 |
Comparison: ANS X axisp-value: 0.098t-test, 2 sided
Comparison: ANS Y axisp-value: 0.389t-test, 2 sided
Comparison: ANS Z axisp-value: 0.78t-test, 2 sided
Comparison: A point X axisp-value: 0.054t-test, 2 sided
Comparison: A point Y axisp-value: 0.323t-test, 2 sided
Comparison: A point X axisp-value: 0.371t-test, 2 sided
Comparison: UI level X axisp-value: 0.011t-test, 2 sided
Comparison: UI level Y axisp-value: 0.426t-test, 2 sided
Comparison: UI level Z axisp-value: 0.621t-test, 2 sided
Comparison: pronasale X axisp-value: 0.275t-test, 2 sided
Comparison: pronasale Y axisp-value: 0.361t-test, 2 sided
Comparison: pronasale Z axisp-value: 0.284t-test, 2 sided
Comparison: subnasale X axisp-value: 0.119t-test, 2 sided
Comparison: subnasale Y axisp-value: 0.019t-test, 2 sided
Comparison: subnasale Z axisp-value: 0.034t-test, 2 sided
Comparison: labiale superious X axisp-value: 0.422t-test, 2 sided
Comparison: labiale superious Y axisp-value: 0.177t-test, 2 sided
Comparison: labiale superious Z axisp-value: 0.133t-test, 2 sided
Secondary
14 Nasolabial Linear Parameters
1. baseline characteristics: intercanthulus distance 2. nasal linear parameters 3. nasolabial linear parameters
Time frame: up to post-operation 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | nasal tip protrusion change | -0.11 mm | Standard Deviation 0.92 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | L nostril show vertical dimension | -0.20 mm | Standard Deviation 1.42 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Intercanthal distance change | 0.04 mm | Standard Deviation 0.82 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Columellar length change | 0.38 mm | Standard Deviation 1.92 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Nasal width change | 0.31 mm | Standard Deviation 1.31 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Cutaneous height of upper lip change | 0.81 mm | Standard Deviation 1.87 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | nasal length change | 0.38 mm | Standard Deviation 2.41 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Overall upper lip height change | 0.63 mm | Standard Deviation 1.5 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Alar base width change | 0.62 mm | Standard Deviation 2.08 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | nasal height change | 0.78 mm | Standard Deviation 2.27 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Lower prolabial width change | -0.76 mm | Standard Deviation 1.56 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | R nostril show vertical dimension change | -0.19 mm | Standard Deviation 1.52 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Upper lip protrusion change | -1.88 mm | Standard Deviation 3.26 |
| Modified Alar Cinch Suture | 14 Nasolabial Linear Parameters | Vermilion height of upper lip change | 0.55 mm | Standard Deviation 1.64 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Upper lip protrusion change | 0.41 mm | Standard Deviation 5.12 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Intercanthal distance change | -0.62 mm | Standard Deviation 2.35 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | nasal height change | -0.80 mm | Standard Deviation 3.91 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | nasal length change | -0.81 mm | Standard Deviation 2.88 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | nasal tip protrusion change | 0.46 mm | Standard Deviation 1.42 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Nasal width change | 0.13 mm | Standard Deviation 2.25 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Alar base width change | 0.26 mm | Standard Deviation 1.85 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | R nostril show vertical dimension change | -0.27 mm | Standard Deviation 1.21 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | L nostril show vertical dimension | -0.13 mm | Standard Deviation 1.87 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Columellar length change | 0.97 mm | Standard Deviation 1.6 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Cutaneous height of upper lip change | 0.38 mm | Standard Deviation 1.11 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Overall upper lip height change | 0.25 mm | Standard Deviation 1.86 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Vermilion height of upper lip change | 0.55 mm | Standard Deviation 1.35 |
| Conventional Alar Base Cinch Suture | 14 Nasolabial Linear Parameters | Lower prolabial width change | -0.40 mm | Standard Deviation 1.61 |
Comparison: Intercanthal distancep-value: 0.218t-test, 2 sided
Comparison: nasal heightp-value: 0.336t-test, 2 sided
p-value: 0.192t-test, 2 sided
Comparison: nasal tip protrusionp-value: 0.135t-test, 2 sided
Comparison: nasal widthp-value: 0.277t-test, 2 sided
Comparison: alar base widthp-value: 0.505t-test, 2 sided
Comparison: R nostril show vertical dimensionp-value: 0.299t-test, 2 sided
Comparison: L nostril show vertical dimensionp-value: 0.738t-test, 2 sided
Comparison: columellar lengthp-value: 0.008t-test, 2 sided
Comparison: cutaneious height of upper lipp-value: 0.116t-test, 2 sided
Comparison: overall upper lip heightp-value: 0.528t-test, 2 sided
Comparison: vermillion height of upper lipp-value: 0.123t-test, 2 sided
Comparison: lower prolabial widthp-value: 0.25t-test, 2 sided
Comparison: upper lip protrusionp-value: 0.706t-test, 2 sided
Comparison: intercanthal distancep-value: 0.804t-test, 2 sided
Comparison: nasal heightp-value: 0.114t-test, 2 sided
Comparison: Nasal lengthp-value: 0.457t-test, 2 sided
Comparison: Nasal tip protrusionp-value: 0.565t-test, 2 sided
Comparison: nasal widthp-value: 0.781t-test, 2 sided
Comparison: alar base widthp-value: 0.164t-test, 2 sided
Comparison: R nostril show vertical dimensionp-value: 0.554t-test, 2 sided
Comparison: L nostril show vertical dimensionp-value: 0.508t-test, 2 sided
Comparison: columellar lengthp-value: 0.358t-test, 2 sided
Comparison: cutaneous height of upper lipp-value: 0.049t-test, 2 sided
Comparison: overall upper lip heightp-value: 0.057t-test, 2 sided
Comparison: vermillion height of upper lipp-value: 0.062t-test, 2 sided
Comparison: lower prolabial widthp-value: 0.029t-test, 2 sided
Comparison: upper lip protrusionp-value: 0.011t-test, 2 sided
Comparison: intercanthal distancep-value: 0.211t-test, 2 sided
Comparison: nasal heightp-value: 0.102t-test, 2 sided
Comparison: nasal lengthp-value: 0.136t-test, 2 sided
Comparison: nasal tip protrusionp-value: 0.113t-test, 2 sided
Comparison: nasal widthp-value: 0.115t-test, 2 sided
Comparison: alar base widthp-value: 0.535t-test, 2 sided
Comparison: R nostril show vertical dimensionp-value: 0.85t-test, 2 sided
Comparison: L nostril show vertical dimensionp-value: 0.891t-test, 2 sided
Comparison: columellar lengthp-value: 0.262t-test, 2 sided
Comparison: cutaneous height of upper lipp-value: 0.344t-test, 2 sided
Comparison: overall upper lip heightp-value: 0.057t-test, 2 sided
Comparison: vermillion height of upper lipp-value: 0.995t-test, 2 sided
Comparison: lower prolabial widthp-value: 0.44t-test, 2 sided
Comparison: upper lip protrusionp-value: 0.078t-test, 2 sided
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®)
Time frame: up to post-operation 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Alar Cinch Suture | 1 Nasolabial Angular Parameters | 3.25 degree | Standard Deviation 7.25 |
| Conventional Alar Base Cinch Suture | 1 Nasolabial Angular Parameters | 2.92 degree | Standard Deviation 8.28 |
p-value: 0.104t-test, 2 sided
p-value: 0.043t-test, 2 sided
p-value: 0.888t-test, 2 sided