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The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01473745
Recruitment Status : Completed
First Posted : November 17, 2011
Results First Posted : September 8, 2014
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Conditions in T74.31 or T76.31
Interventions Procedure: conventional alar base cinch
Procedure: modified alar base cinch
Enrollment 48
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.
Arm/Group Title Conventional Alar Cinch Group Modified Alar Cinch Group
Hide Arm/Group Description Patients received conventional alar base cinch technique during LeFort I osteotomy procedure. Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
Period Title: Overall Study
Started 24 24
Completed 24 24
Not Completed 0 0
Arm/Group Title Modified Alar Cinch Suture Conventional Alar Base Cinch Suture Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
Taiwanese Class III patients
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 24 participants 24 participants 48 participants
24.13
(19 to 57)
23.78
(18 to 34)
23.92
(18 to 57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
17
  70.8%
18
  75.0%
35
  72.9%
Male
7
  29.2%
6
  25.0%
13
  27.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Taiwanese Number Analyzed 24 participants 24 participants 48 participants
24 24 48
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 24 participants 24 participants 48 participants
24 24 48
1.Primary Outcome
Title Soft and Hard Tissue Landmarks Movement
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mm
ANS point X axis 0.95  (1.29) -0.5  (1.09)
ANS point Y axis -0.95  (2.10) -0.32  (2.82)
ANS point Z axis 0.50  (2.35) -0.71  (2.73)
A point X axis 0.22  (1.50) -0.58  (1.22)
A point Y axis -1.58  (1.95) -0.95  (2.29)
A point Z axis 1.11  (2.43) 1.83  (2.97)
UI level X axis -0.86  (1.53) 0.30  (1.44)
UI level Y axis -1.08  (1.82) -0.58  (2.40)
UI level Z axis 2.42  (3.95) 1.91  (2.88)
pronasale X axis -0.35  (1.70) 0.14  (1.23)
pronasale Y axis -0.29  (1.42) -0.12  (1.62)
pronasale Z axis 0.48  (1.04) 0.08  (1.43)
subnasale X axis -0.67  (1.88) 0.05  (1.13)
subnasale Y axis -0.62  (1.32) 0.21  (0.97)
subnasale Z axis 1.08  (1.89) -0.03  (1.55)
labiale suprious X axis -0.74  (2.02) 0.00  (1.64)
labiale suprious Y axis -0.03  (2.09) -0.90  (1.78)
labiale suprious Z axis -0.03  (2.09) 0.42  (2.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments ANS X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments ANS Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.389
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments ANS Z axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments A point X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments A point Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.323
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments A point X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.371
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments UI level X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments UI level Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.426
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments UI level Z axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.621
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments pronasale X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.275
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments pronasale Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.361
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments pronasale Z axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.284
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments subnasale X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments subnasale Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments subnasale Z axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments labiale superious X axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.422
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments labiale superious Y axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.177
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments labiale superious Z axis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
2.Secondary Outcome
Title 14 Nasolabial Linear Parameters
Hide Description
  1. baseline characteristics: intercanthulus distance
  2. nasal linear parameters
  3. nasolabial linear parameters
Time Frame up to post-operation 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: mm
Intercanthal distance change 0.04  (0.82) -0.62  (2.35)
nasal height change 0.78  (2.27) -0.80  (3.91)
nasal length change 0.38  (2.41) -0.81  (2.88)
nasal tip protrusion change -0.11  (0.92) 0.46  (1.42)
Nasal width change 0.31  (1.31) 0.13  (2.25)
Alar base width change 0.62  (2.08) 0.26  (1.85)
R nostril show vertical dimension change -0.19  (1.52) -0.27  (1.21)
L nostril show vertical dimension -0.20  (1.42) -0.13  (1.87)
Columellar length change 0.38  (1.92) 0.97  (1.60)
Cutaneous height of upper lip change 0.81  (1.87) 0.38  (1.11)
Overall upper lip height change 0.63  (1.50) 0.25  (1.86)
Vermilion height of upper lip change 0.55  (1.64) 0.55  (1.35)
Lower prolabial width change -0.76  (1.56) -0.40  (1.61)
Upper lip protrusion change -1.88  (3.26) 0.41  (5.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments Intercanthal distance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.218
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments nasal height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.336
Comments [Not Specified]
Method t-test, 2 sided
Comments P- value < 0.05 was set as statistical significance.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments [Not Specified]
Method t-test, 2 sided
Comments P- value < 0.05 was set as statistical significance
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments nasal tip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.135
Comments [Not Specified]
Method t-test, 2 sided
Comments P value < 0.05 was set as statistical significance.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments nasal width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.277
Comments [Not Specified]
Method t-test, 2 sided
Comments P value < 0.05 was set as statistical significance.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments alar base width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.505
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments R nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments L nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.738
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments columellar length
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments cutaneious height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments overall upper lip height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments vermillion height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.123
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments lower prolabial width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.250
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments upper lip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.706
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments intercanthal distance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.804
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments nasal height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.114
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments Nasal length
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments Nasal tip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.565
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments nasal width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.781
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments alar base width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments R nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.554
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments L nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments columellar length
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.358
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments cutaneous height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments overall upper lip height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments vermillion height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments lower prolabial width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments upper lip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments intercanthal distance
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments nasal height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.102
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments nasal length
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.136
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments nasal tip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.113
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 33 Hide Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments nasal width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.115
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 34 Hide Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments alar base width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.535
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 35 Hide Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments R nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 36 Hide Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments L nostril show vertical dimension
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.891
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 37 Hide Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments columellar length
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.262
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 38 Hide Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments cutaneous height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.344
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 39 Hide Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments overall upper lip height
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 40 Hide Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments vermillion height of upper lip
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.995
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 41 Hide Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments lower prolabial width
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.440
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
Show Statistical Analysis 42 Hide Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments upper lip protrusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.078
Comments [Not Specified]
Method t-test, 2 sided
Comments P-value < 0.05 was set as statistical significance(*).
3.Secondary Outcome
Title 1 Nasolabial Angular Parameters
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: degree
3.25  (7.25) 2.92  (8.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conventional Alar Base Cinch Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.104
Comments intergroup difference of conventional group
Method t-test, 2 sided
Comments P value < 0.05 was set as statistical significance.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments Intergroup difference of modified group
Method t-test, 2 sided
Comments P value <0.05 was set as statistical significance.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Modified Alar Cinch Suture, Conventional Alar Base Cinch Suture
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.888
Comments [Not Specified]
Method t-test, 2 sided
Comments P value < 0.05 was set as statistical significance.
Time Frame 6 months after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Modified Alar Cinch Suture Conventional Alar Base Cinch Suture
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
no financial PI disclosure
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yi Hsuan Chen
Organization: ChangGungMH
Phone: +886227135211 ext 3533
EMail: acantehr@gmail.com
Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01473745     History of Changes
Other Study ID Numbers: CGMH-100-1653A3
ChangGungMH ( Other Identifier: ChangGungMH )
First Submitted: November 15, 2011
First Posted: November 17, 2011
Results First Submitted: August 6, 2014
Results First Posted: September 8, 2014
Last Update Posted: November 4, 2014