Trial Outcomes & Findings for The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy (NCT NCT01473745)
NCT ID: NCT01473745
Last Updated: 2014-11-04
Results Overview
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.
COMPLETED
PHASE2/PHASE3
48 participants
The hard tissue movements were assessed after surgery 4-6 weeks.The soft tissue movements were assessed after surgery 6 months.
2014-11-04
Participant Flow
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.
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.
Participant milestones
| Measure |
Conventional Alar Cinch Group
Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
|
Modified Alar Cinch Group
Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Nasal Changes Affected by Different Alar Base Suture Techniques After Maxillary LeFort I Osteotomy
Baseline characteristics by cohort
| Measure |
Modified Alar Cinch Suture
n=24 Participants
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 Alar Base Cinch Suture
n=24 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
24.13 years
n=5 Participants
|
23.78 years
n=7 Participants
|
23.92 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Taiwanese
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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)
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.
Outcome measures
| Measure |
Modified Alar Cinch Suture
n=24 Participants
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 Alar Base Cinch Suture
n=24 Participants
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.
|
|---|---|---|
|
Soft and Hard Tissue Landmarks Movement
ANS point X axis
|
0.95 mm
Standard Deviation 1.29
|
-0.5 mm
Standard Deviation 1.09
|
|
Soft and Hard Tissue Landmarks Movement
ANS point Y axis
|
-0.95 mm
Standard Deviation 2.10
|
-0.32 mm
Standard Deviation 2.82
|
|
Soft and Hard Tissue Landmarks Movement
ANS point Z axis
|
0.50 mm
Standard Deviation 2.35
|
-0.71 mm
Standard Deviation 2.73
|
|
Soft and Hard Tissue Landmarks Movement
A point X axis
|
0.22 mm
Standard Deviation 1.50
|
-0.58 mm
Standard Deviation 1.22
|
|
Soft and Hard Tissue Landmarks Movement
A point Y axis
|
-1.58 mm
Standard Deviation 1.95
|
-0.95 mm
Standard Deviation 2.29
|
|
Soft and Hard Tissue Landmarks Movement
A point Z axis
|
1.11 mm
Standard Deviation 2.43
|
1.83 mm
Standard Deviation 2.97
|
|
Soft and Hard Tissue Landmarks Movement
UI level X axis
|
-0.86 mm
Standard Deviation 1.53
|
0.30 mm
Standard Deviation 1.44
|
|
Soft and Hard Tissue Landmarks Movement
UI level Y axis
|
-1.08 mm
Standard Deviation 1.82
|
-0.58 mm
Standard Deviation 2.40
|
|
Soft and Hard Tissue Landmarks Movement
UI level Z axis
|
2.42 mm
Standard Deviation 3.95
|
1.91 mm
Standard Deviation 2.88
|
|
Soft and Hard Tissue Landmarks Movement
pronasale X axis
|
-0.35 mm
Standard Deviation 1.70
|
0.14 mm
Standard Deviation 1.23
|
|
Soft and Hard Tissue Landmarks Movement
pronasale Y axis
|
-0.29 mm
Standard Deviation 1.42
|
-0.12 mm
Standard Deviation 1.62
|
|
Soft and Hard Tissue Landmarks Movement
pronasale Z axis
|
0.48 mm
Standard Deviation 1.04
|
0.08 mm
Standard Deviation 1.43
|
|
Soft and Hard Tissue Landmarks Movement
subnasale X axis
|
-0.67 mm
Standard Deviation 1.88
|
0.05 mm
Standard Deviation 1.13
|
|
Soft and Hard Tissue Landmarks Movement
subnasale Y axis
|
-0.62 mm
Standard Deviation 1.32
|
0.21 mm
Standard Deviation 0.97
|
|
Soft and Hard Tissue Landmarks Movement
subnasale Z axis
|
1.08 mm
Standard Deviation 1.89
|
-0.03 mm
Standard Deviation 1.55
|
|
Soft and Hard Tissue Landmarks Movement
labiale suprious X axis
|
-0.74 mm
Standard Deviation 2.02
|
0.00 mm
Standard Deviation 1.64
|
|
Soft and Hard Tissue Landmarks Movement
labiale suprious Y axis
|
-0.03 mm
Standard Deviation 2.09
|
-0.90 mm
Standard Deviation 1.78
|
|
Soft and Hard Tissue Landmarks Movement
labiale suprious Z axis
|
-0.03 mm
Standard Deviation 2.09
|
0.42 mm
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: up to post-operation 6 months1. baseline characteristics: intercanthulus distance 2. nasal linear parameters 3. nasolabial linear parameters
Outcome measures
| Measure |
Modified Alar Cinch Suture
n=24 Participants
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 Alar Base Cinch Suture
n=24 Participants
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.
|
|---|---|---|
|
14 Nasolabial Linear Parameters
Intercanthal distance change
|
0.04 mm
Standard Deviation 0.82
|
-0.62 mm
Standard Deviation 2.35
|
|
14 Nasolabial Linear Parameters
nasal height change
|
0.78 mm
Standard Deviation 2.27
|
-0.80 mm
Standard Deviation 3.91
|
|
14 Nasolabial Linear Parameters
nasal length change
|
0.38 mm
Standard Deviation 2.41
|
-0.81 mm
Standard Deviation 2.88
|
|
14 Nasolabial Linear Parameters
nasal tip protrusion change
|
-0.11 mm
Standard Deviation 0.92
|
0.46 mm
Standard Deviation 1.42
|
|
14 Nasolabial Linear Parameters
Nasal width change
|
0.31 mm
Standard Deviation 1.31
|
0.13 mm
Standard Deviation 2.25
|
|
14 Nasolabial Linear Parameters
Alar base width change
|
0.62 mm
Standard Deviation 2.08
|
0.26 mm
Standard Deviation 1.85
|
|
14 Nasolabial Linear Parameters
R nostril show vertical dimension change
|
-0.19 mm
Standard Deviation 1.52
|
-0.27 mm
Standard Deviation 1.21
|
|
14 Nasolabial Linear Parameters
L nostril show vertical dimension
|
-0.20 mm
Standard Deviation 1.42
|
-0.13 mm
Standard Deviation 1.87
|
|
14 Nasolabial Linear Parameters
Columellar length change
|
0.38 mm
Standard Deviation 1.92
|
0.97 mm
Standard Deviation 1.60
|
|
14 Nasolabial Linear Parameters
Cutaneous height of upper lip change
|
0.81 mm
Standard Deviation 1.87
|
0.38 mm
Standard Deviation 1.11
|
|
14 Nasolabial Linear Parameters
Overall upper lip height change
|
0.63 mm
Standard Deviation 1.50
|
0.25 mm
Standard Deviation 1.86
|
|
14 Nasolabial Linear Parameters
Vermilion height of upper lip change
|
0.55 mm
Standard Deviation 1.64
|
0.55 mm
Standard Deviation 1.35
|
|
14 Nasolabial Linear Parameters
Lower prolabial width change
|
-0.76 mm
Standard Deviation 1.56
|
-0.40 mm
Standard Deviation 1.61
|
|
14 Nasolabial Linear Parameters
Upper lip protrusion change
|
-1.88 mm
Standard Deviation 3.26
|
0.41 mm
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: up to post-operation 6 months2D nasolabial angular parameter: Nasolabial angle (NLA) (The NLA was a two dimensional measurement and was measured at the midsagittal plane with Image J software®)
Outcome measures
| Measure |
Modified Alar Cinch Suture
n=24 Participants
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 Alar Base Cinch Suture
n=24 Participants
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.
|
|---|---|---|
|
1 Nasolabial Angular Parameters
|
3.25 degree
Standard Deviation 7.25
|
2.92 degree
Standard Deviation 8.28
|
Adverse Events
Modified Alar Cinch Suture
Conventional Alar Base Cinch Suture
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee no financial PI disclosure
- Publication restrictions are in place
Restriction type: OTHER