Rows: 35
Columns: 20
$ patient_number <dbl> 1, 2, 3, 4, 5, 6, …
$ gender_1_male_2_female <chr> "female", "female"…
$ age <dbl> 41, 23, 17, 40, 19…
$ study_groups_1_test_2_control <chr> "TEST", "TEST", "C…
$ type_of_procedure_1_bsso_2_bimax_3_bsso_g_4_bimax_g <chr> "BiMax", "BiMax", …
$ gap_size_r_mm <dbl> 5.14, 1.55, 5.88, …
$ gap_size_l_mm <dbl> 8.60, 1.39, 11.08,…
$ rotation_of_occlusal_plane <dbl> -2.675, 4.965, -0.…
$ fracture_pattern_r_1_type_2_type <chr> "type 2", "type 2"…
$ fracture_pattern_l_1_type_2_type <chr> "type 2", "type 1"…
$ bad_split_presence_r_0_no_1_yes <chr> "no", "no", "no", …
$ bad_split_precence_l_0_no_1_yes <dbl> 0, 0, 0, 0, 0, 0, …
$ proximal_segment_postoperative_position_r <dbl> 1, 2, 1, 1, 1, 1, …
$ proximal_segment_postoperative_position_l <dbl> 1, 1, 1, 1, 1, 1, …
$ bone_gain_r_mm3 <dbl> 371, 706, 1051, 58…
$ bone_gain_l_mm3 <dbl> 491, 548, 646, 800…
$ bone_resorption_remodelling_r_mm3 <dbl> 230, 233, 451, 256…
$ bone_resorption_remodelling_l_mm3 <dbl> 236, 397, 61, 137,…
$ net_bone_volume_change_r_mm3 <dbl> 141, 473, 600, 324…
$ net_bone_volume_change_l_mm3 <dbl> 255, 151, 585, 663…2025_lana_prf_clinical_trial_BBCE
Data
EDA
| Characteristic | CONTROL N = 141 |
TEST N = 211 |
|---|---|---|
| gender | ||
| female | 7 (50%) | 10 (48%) |
| male | 7 (50%) | 11 (52%) |
| age | 21 (19, 23) | 25 (20, 33) |
| type_of_procedure | ||
| BiMax | 10 (71%) | 16 (76%) |
| BiMax + Genioplasty | 0 (0%) | 3 (14%) |
| BSSO | 4 (29%) | 1 (4.8%) |
| BSSO + Genioplasty | 0 (0%) | 1 (4.8%) |
| gap_size_r_mm | 2.52 (1.47, 5.28) | 3.13 (1.74, 5.13) |
| gap_size_l_mm | 3.36 (2.23, 6.80) | 3.58 (2.60, 5.91) |
| rotation_of_occlusal_plane | 1.2 (-0.6, 3.0) | 0.6 (0.0, 5.0) |
| fracture_pattern_r | ||
| type 1 | 8 (62%) | 15 (71%) |
| type 2 | 5 (38%) | 6 (29%) |
| Unknown | 1 | 0 |
| fracture_pattern_l | ||
| type 1 | 6 (50%) | 14 (67%) |
| type 2 | 6 (50%) | 7 (33%) |
| Unknown | 2 | 0 |
| bad_split_presence_r | 1 (7.1%) | 0 (0%) |
| bad_split_presence_l | 2 (14%) | 0 (0%) |
| proximal_segment_postoperative_position_r | ||
| 1 | 5 (36%) | 10 (48%) |
| 2 | 7 (50%) | 9 (43%) |
| 3 | 2 (14%) | 2 (9.5%) |
| proximal_segment_postoperative_position_l | ||
| 1 | 8 (57%) | 12 (57%) |
| 2 | 5 (36%) | 7 (33%) |
| 3 | 1 (7.1%) | 2 (9.5%) |
| bone_gain_r_mm3 | 517 (391, 607) | 640 (546, 900) |
| bone_gain_l_mm3 | 463 (268, 646) | 566 (488, 734) |
| bone_resorption_remodelling_r_mm3 | 279 (218, 352) | 233 (191, 355) |
| bone_resorption_remodelling_l_mm3 | 218 (166, 321) | 276 (181, 365) |
| net_bone_volume_change_r_mm3 | 286 (79, 362) | 414 (355, 613) |
| net_bone_volume_change_l_mm3 | 153 (38, 383) | 320 (185, 515) |
| 1 n (%); Median (Q1, Q3) | ||
MODELLING
Gap size model
| Characteristic | Beta | 95% CI |
|---|---|---|
| Study Group | ||
| CONTROL | — | — |
| TEST | -0.62 | -2.2, 0.92 |
| Gender | ||
| female | — | — |
| male | 0.19 | -1.2, 1.6 |
| Age | 0.04 | -0.06, 0.13 |
| Type of Procedure | ||
| BiMax | — | — |
| BiMax + Genioplasty | 6.1 | 3.6, 8.6 |
| BSSO | 0.07 | -2.0, 2.2 |
| BSSO + Genioplasty | 1.4 | -2.7, 5.5 |
| Side (R / L) | ||
| gap_size_l_mm | — | — |
| gap_size_r_mm | -1.0 | -2.0, -0.08 |
| Abbreviation: CI = Confidence Interval | ||
Check assumptions
Bone gain model
| Characteristic | Beta | 95% CI |
|---|---|---|
| Study Group | ||
| CONTROL | — | — |
| TEST | 101 | -42, 244 |
| Gender | ||
| female | — | — |
| male | 138 | 6.5, 270 |
| Age | -6.6 | -15, 2.0 |
| Type of Procedure | ||
| BiMax | — | — |
| BiMax + Genioplasty | 561 | 327, 794 |
| BSSO | -134 | -328, 61 |
| BSSO + Genioplasty | 81 | -301, 462 |
| Side (R / L) | ||
| bone_gain_l_mm3 | — | — |
| bone_gain_r_mm3 | 66 | -18, 150 |
| Abbreviation: CI = Confidence Interval | ||
Bone resorption
| Characteristic | Beta | 95% CI |
|---|---|---|
| Study Group | ||
| CONTROL | — | — |
| TEST | -19 | -109, 72 |
| Gender | ||
| female | — | — |
| male | 67 | -17, 150 |
| Age | -0.12 | -5.5, 5.3 |
| Type of Procedure | ||
| BiMax | — | — |
| BiMax + Genioplasty | 66 | -82, 214 |
| BSSO | 30 | -94, 153 |
| BSSO + Genioplasty | -5.2 | -247, 237 |
| Side (R / L) | ||
| bone_resorption_remodelling_l_mm3 | — | — |
| bone_resorption_remodelling_r_mm3 | 28 | -27, 83 |
| Abbreviation: CI = Confidence Interval | ||
Net volume model
| Characteristic | Beta | 95% CI |
|---|---|---|
| Study Group | ||
| CONTROL | — | — |
| TEST | 120 | -35, 275 |
| Gender | ||
| female | — | — |
| male | 72 | -71, 215 |
| Age | -6.5 | -16, 2.8 |
| Type of Procedure | ||
| BiMax | — | — |
| BiMax + Genioplasty | 495 | 242, 748 |
| BSSO | -164 | -375, 48 |
| BSSO + Genioplasty | 86 | -328, 499 |
| Side (R / L) | ||
| net_bone_volume_change_l_mm3 | — | — |
| net_bone_volume_change_r_mm3 | 38 | -51, 128 |
| Abbreviation: CI = Confidence Interval | ||
ETC
check if each patient have both sides
# A tibble: 1 × 2
n_groups n
<int> <int>
1 1 35# A tibble: 2 × 2
study_group n
<chr> <int>
1 CONTROL 14
2 TEST 21Stats power test
# Fixed Effects
Parameter | Coefficient | SE | 95% CI
-----------------------------------------------------------------------------
(Intercept) | 3.41 | 1.25 | [ 0.91, 5.90]
study group [TEST] | -0.62 | 0.79 | [-2.20, 0.95]
gender [male] | 0.19 | 0.72 | [-1.26, 1.64]
age | 0.04 | 0.05 | [-0.06, 0.13]
type of procedure [BiMax + Genioplasty] | 6.14 | 1.28 | [ 3.57, 8.70]
type of procedure [BSSO] | 0.07 | 1.07 | [-2.07, 2.21]
type of procedure [BSSO + Genioplasty] | 1.36 | 2.10 | [-2.83, 5.55]
side [gap_size_r_mm] | -1.03 | 0.49 | [-2.01, -0.06]
Parameter | t(60) | p
--------------------------------------------------------
(Intercept) | 2.73 | 0.008
study group [TEST] | -0.79 | 0.430
gender [male] | 0.26 | 0.793
age | 0.76 | 0.450
type of procedure [BiMax + Genioplasty] | 4.78 | < .001
type of procedure [BSSO] | 0.06 | 0.949
type of procedure [BSSO + Genioplasty] | 0.65 | 0.519
side [gap_size_r_mm] | -2.12 | 0.038
# Random Effects
Parameter | Coefficient
--------------------------------------------
SD (Intercept: patient_number) | 1.37
SD (Residual) | 2.04Simulating: | |Simulating: |= |Simulating: |== |Simulating: |=== |Simulating: |==== |Simulating: |===== |Simulating: |====== |Simulating: |======= |Simulating: |======== |Simulating: |========= |Simulating: |========== |Simulating: |=========== |Simulating: |============ |Simulating: |============= |Simulating: |============== |Simulating: |=============== |Simulating: |================ |Simulating: |================= |Simulating: |================== |Simulating: |=================== |Simulating: |==================== |Simulating: |===================== |Simulating: |====================== |Simulating: |======================= |Simulating: |======================== |Simulating: |========================= |Simulating: |========================== |Simulating: |=========================== |Simulating: |============================ |Simulating: |============================= |Simulating: |============================== |Simulating: |=============================== |Simulating: |================================ |Simulating: |================================= |Simulating: |================================== |Simulating: |=================================== |Simulating: |==================================== |Simulating: |===================================== |Simulating: |====================================== |Simulating: |======================================= |Simulating: |======================================== |Simulating: |========================================= |Simulating: |========================================== |Simulating: |=========================================== |Simulating: |============================================ |Simulating: |============================================= |Simulating: |============================================== |Simulating: |=============================================== |Simulating: |================================================ |Simulating: |================================================= |Simulating: |================================================== |Simulating: |=================================================== |Simulating: |==================================================== |Simulating: |===================================================== |Simulating: |====================================================== |Simulating: |======================================================= |Simulating: |======================================================== |Simulating: |========================================================= |Simulating: |========================================================== |Simulating: |=========================================================== |Simulating: |============================================================ |Simulating: |============================================================= |Simulating: |============================================================== |Simulating: |=============================================================== |Simulating: |================================================================ |Simulating: |================================================================= |Simulating: |==================================================================|# Fixed Effects
Parameter | Coefficient | SE
--------------------------------------------------------------
(Intercept) | 596.12 | 115.41
study group [TEST] | 101.00 | 72.94
gender [male] | 138.17 | 67.20
age | -6.59 | 4.36
type of procedure [BiMax + Genioplasty] | 560.86 | 119.08
type of procedure [BSSO] | -133.94 | 99.26
type of procedure [BSSO + Genioplasty] | 80.52 | 194.53
side [bone_gain_r_mm3] | 66.14 | 42.92
Parameter | 95% CI | t(60) | p
----------------------------------------------------------------------------
(Intercept) | [ 365.27, 826.98] | 5.17 | < .001
study group [TEST] | [ -44.90, 246.89] | 1.38 | 0.171
gender [male] | [ 3.75, 272.59] | 2.06 | 0.044
age | [ -15.32, 2.13] | -1.51 | 0.136
type of procedure [BiMax + Genioplasty] | [ 322.66, 799.06] | 4.71 | < .001
type of procedure [BSSO] | [-332.48, 64.61] | -1.35 | 0.182
type of procedure [BSSO + Genioplasty] | [-308.60, 469.63] | 0.41 | 0.680
side [bone_gain_r_mm3] | [ -19.70, 151.99] | 1.54 | 0.129
# Random Effects
Parameter | Coefficient
--------------------------------------------
SD (Intercept: patient_number) | 134.37
SD (Residual) | 179.53Simulating: | |Simulating: |= |Simulating: |== |Simulating: |=== |Simulating: |==== |Simulating: |===== |Simulating: |====== |Simulating: |======= |Simulating: |======== |Simulating: |========= |Simulating: |========== |Simulating: |=========== |Simulating: |============ |Simulating: |============= |Simulating: |============== |Simulating: |=============== |Simulating: |================ |Simulating: |================= |Simulating: |================== |Simulating: |=================== |Simulating: |==================== |Simulating: |===================== |Simulating: |====================== |Simulating: |======================= |Simulating: |======================== |Simulating: |========================= |Simulating: |========================== |Simulating: |=========================== |Simulating: |============================ |Simulating: |============================= |Simulating: |============================== |Simulating: |=============================== |Simulating: |================================ |Simulating: |================================= |Simulating: |================================== |Simulating: |=================================== |Simulating: |==================================== |Simulating: |===================================== |Simulating: |====================================== |Simulating: |======================================= |Simulating: |======================================== |Simulating: |========================================= |Simulating: |========================================== |Simulating: |=========================================== |Simulating: |============================================ |Simulating: |============================================= |Simulating: |============================================== |Simulating: |=============================================== |Simulating: |================================================ |Simulating: |================================================= |Simulating: |================================================== |Simulating: |=================================================== |Simulating: |==================================================== |Simulating: |===================================================== |Simulating: |====================================================== |Simulating: |======================================================= |Simulating: |======================================================== |Simulating: |========================================================= |Simulating: |========================================================== |Simulating: |=========================================================== |Simulating: |============================================================ |Simulating: |============================================================= |Simulating: |============================================================== |Simulating: |=============================================================== |Simulating: |================================================================ |Simulating: |================================================================= |Simulating: |==================================================================|# Fixed Effects
Parameter | Coefficient | SE
---------------------------------------------------------------
(Intercept) | 237.16 | 73.31
study group [TEST] | -18.71 | 46.28
gender [male] | 66.59 | 42.64
age | -0.12 | 2.77
type of procedure [BiMax + Genioplasty] | 65.83 | 75.56
type of procedure [BSSO] | 29.65 | 62.98
type of procedure [BSSO + Genioplasty] | -5.16 | 123.44
side [bone_resorption_remodelling_r_mm3] | 28.00 | 28.05
Parameter | 95% CI | t(60) | p
----------------------------------------------------------------------------
(Intercept) | [ 90.52, 383.80] | 3.23 | 0.002
study group [TEST] | [-111.28, 73.87] | -0.40 | 0.688
gender [male] | [ -18.71, 151.88] | 1.56 | 0.124
age | [ -5.65, 5.42] | -0.04 | 0.967
type of procedure [BiMax + Genioplasty] | [ -85.32, 216.98] | 0.87 | 0.387
type of procedure [BSSO] | [ -96.34, 155.63] | 0.47 | 0.640
type of procedure [BSSO + Genioplasty] | [-252.08, 241.76] | -0.04 | 0.967
side [bone_resorption_remodelling_r_mm3] | [ -28.11, 84.11] | 1.00 | 0.322
# Random Effects
Parameter | Coefficient
--------------------------------------------
SD (Intercept: patient_number) | 82.91
SD (Residual) | 117.35Simulating: | |Simulating: |= |Simulating: |== |Simulating: |=== |Simulating: |==== |Simulating: |===== |Simulating: |====== |Simulating: |======= |Simulating: |======== |Simulating: |========= |Simulating: |========== |Simulating: |=========== |Simulating: |============ |Simulating: |============= |Simulating: |============== |Simulating: |=============== |Simulating: |================ |Simulating: |================= |Simulating: |================== |Simulating: |=================== |Simulating: |==================== |Simulating: |===================== |Simulating: |====================== |Simulating: |======================= |Simulating: |======================== |Simulating: |========================= |Simulating: |========================== |Simulating: |=========================== |Simulating: |============================ |Simulating: |============================= |Simulating: |============================== |Simulating: |=============================== |Simulating: |================================ |Simulating: |================================= |Simulating: |================================== |Simulating: |=================================== |Simulating: |==================================== |Simulating: |===================================== |Simulating: |====================================== |Simulating: |======================================= |Simulating: |======================================== |Simulating: |========================================= |Simulating: |========================================== |Simulating: |=========================================== |Simulating: |============================================ |Simulating: |============================================= |Simulating: |============================================== |Simulating: |=============================================== |Simulating: |================================================ |Simulating: |================================================= |Simulating: |================================================== |Simulating: |=================================================== |Simulating: |==================================================== |Simulating: |===================================================== |Simulating: |====================================================== |Simulating: |======================================================= |Simulating: |======================================================== |Simulating: |========================================================= |Simulating: |========================================================== |Simulating: |=========================================================== |Simulating: |============================================================ |Simulating: |============================================================= |Simulating: |============================================================== |Simulating: |=============================================================== |Simulating: |================================================================ |Simulating: |================================================================= |Simulating: |==================================================================|# Fixed Effects
Parameter | Coefficient | SE
--------------------------------------------------------------
(Intercept) | 358.96 | 125.16
study group [TEST] | 119.70 | 79.15
gender [male] | 71.58 | 72.92
age | -6.48 | 4.74
type of procedure [BiMax + Genioplasty] | 495.03 | 129.22
type of procedure [BSSO] | -163.58 | 107.71
type of procedure [BSSO + Genioplasty] | 85.68 | 211.09
side [net_bone_volume_change_r_mm3] | 38.14 | 45.71
Parameter | 95% CI | t(60) | p
----------------------------------------------------------------------------
(Intercept) | [ 108.61, 609.31] | 2.87 | 0.006
study group [TEST] | [ -38.61, 278.02] | 1.51 | 0.136
gender [male] | [ -74.28, 217.45] | 0.98 | 0.330
age | [ -15.95, 2.99] | -1.37 | 0.176
type of procedure [BiMax + Genioplasty] | [ 236.55, 753.52] | 3.83 | < .001
type of procedure [BSSO] | [-379.03, 51.86] | -1.52 | 0.134
type of procedure [BSSO + Genioplasty] | [-336.57, 507.92] | 0.41 | 0.686
side [net_bone_volume_change_r_mm3] | [ -53.29, 129.58] | 0.83 | 0.407
# Random Effects
Parameter | Coefficient
--------------------------------------------
SD (Intercept: patient_number) | 148.17
SD (Residual) | 191.22Simulating: | |Simulating: |= |Simulating: |== |Simulating: |=== |Simulating: |==== |Simulating: |===== |Simulating: |====== |Simulating: |======= |Simulating: |======== |Simulating: |========= |Simulating: |========== |Simulating: |=========== |Simulating: |============ |Simulating: |============= |Simulating: |============== |Simulating: |=============== |Simulating: |================ |Simulating: |================= |Simulating: |================== |Simulating: |=================== |Simulating: |==================== |Simulating: |===================== |Simulating: |====================== |Simulating: |======================= |Simulating: |======================== |Simulating: |========================= |Simulating: |========================== |Simulating: |=========================== |Simulating: |============================ |Simulating: |============================= |Simulating: |============================== |Simulating: |=============================== |Simulating: |================================ |Simulating: |================================= |Simulating: |================================== |Simulating: |=================================== |Simulating: |==================================== |Simulating: |===================================== |Simulating: |====================================== |Simulating: |======================================= |Simulating: |======================================== |Simulating: |========================================= |Simulating: |========================================== |Simulating: |=========================================== |Simulating: |============================================ |Simulating: |============================================= |Simulating: |============================================== |Simulating: |=============================================== |Simulating: |================================================ |Simulating: |================================================= |Simulating: |================================================== |Simulating: |=================================================== |Simulating: |==================================================== |Simulating: |===================================================== |Simulating: |====================================================== |Simulating: |======================================================= |Simulating: |======================================================== |Simulating: |========================================================= |Simulating: |========================================================== |Simulating: |=========================================================== |Simulating: |============================================================ |Simulating: |============================================================= |Simulating: |============================================================== |Simulating: |=============================================================== |Simulating: |================================================================ |Simulating: |================================================================= |Simulating: |==================================================================|power_gap
Power for predictor 'study_group', (95% confidence interval):
0.00% ( 0.00, 3.62)
Test: t-test with Satterthwaite degrees of freedom (package lmerTest)
Based on 100 simulations, (0 warnings, 100 errors)
alpha = 0.05, nrow = 70
Time elapsed: 0 h 0 m 6 s
nb: result might be an observed power calculationpower_gain
Power for predictor 'study_group', (95% confidence interval):
0.00% ( 0.00, 3.62)
Test: t-test with Satterthwaite degrees of freedom (package lmerTest)
Based on 100 simulations, (0 warnings, 100 errors)
alpha = 0.05, nrow = 70
Time elapsed: 0 h 0 m 6 s
nb: result might be an observed power calculationpower_resorption
Power for predictor 'study_group', (95% confidence interval):
0.00% ( 0.00, 3.62)
Test: t-test with Satterthwaite degrees of freedom (package lmerTest)
Based on 100 simulations, (0 warnings, 100 errors)
alpha = 0.05, nrow = 70
Time elapsed: 0 h 0 m 6 s
nb: result might be an observed power calculationpower_net_bone
Power for predictor 'study_group', (95% confidence interval):
0.00% ( 0.00, 3.62)
Test: t-test with Satterthwaite degrees of freedom (package lmerTest)
Based on 100 simulations, (0 warnings, 100 errors)
alpha = 0.05, nrow = 70
Time elapsed: 0 h 0 m 7 s
nb: result might be an observed power calculationHOUSECLEANING
Sample size calculation for future studies
Two-sample t test power calculation
n = 23.60467
d = 0.8333333
sig.level = 0.05
power = 0.8
alternative = two.sided
NOTE: n is number in *each* group[1] 48so, 48 (24 +24) patients are required to detect a difference of 2.5mm if this difference really exists
for 2.0mm is
[1] 74