Introduction
Materials and methods
Trial design
Participants
Reference population
Sample size calculation
Randomization
Control of study bias
Intervention: Surgical procedure
Monitoring and data collection
Clinical parameters
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Recession depth (REC depth): measured in the mid vestibular from the cemento-enamel junction (CEJ) to the deepest point of the pocket. As non-carious cervical lesions were not excluded, if the CEJ was not present or not detectable, it was determined using the technique described by Cairo and Pini-Prato [36] in 2010.
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Recession width (REC width): measured mesio-distally at the level of the CEJ.
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Keratinized tissue width (KTW): measured from the gingival margin to the mucogingival junction.
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Clinical attachment level (CAL), measured from the CEJ to the gingival margin to the deepest point of the pocket (PD + REC depth).
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Percentage of CRC (the number of treated recessions with REC depth = 0 mm): CRC × 100/number of recessions.
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Percentage of MRC (mean preoperative REC depth -mean postoperative REC depth/mean preoperative REC depth × 100) were calculated.
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GT: measured 3 mm apical from the center of the gingival margin (at baseline and 12 months) using a 25-gauge K endodontic file with a rubber stopper, measured perpendicular to the tooth axis under local anesthesia.
Patient-related outcomes measures
Professional esthetic evaluation
Statistical analysis
Results
Study population
Twenty patients (13 women (65%)) with a mean age of 48.59 years (SD:10.32), of whom two were smokers (10%) participated in this study. The 96.39% of the participants had multiple recessions. A total of 111 RT2 recessions were treated (CMX: 58 vs. CTG: 53), among which 65 (CMX: 34 vs. CTG: 31) were in the mandible (58.5%). A total of 31 incisors (27.92%), 36 canines (32.43%), and 44 premolars (39.63%) were included. REC depth, REC width, KTW, GT, and CAL at baseline are shown in Table 1.
Test (CMX) (n = 0) | Control (CTG) (n = 20) | P value | Total | |
---|---|---|---|---|
Age (mean ± SD) | 48.79 ± 10.35 | 48.39 ± 10.59 | 0.73 | 48.59 ± 10.32 |
Females n (%) | 13 (65%) | 13 (65%) | > 0.05 | 13 (65%) |
Smokers n (%) | 1 (5%) | 1 (5%) | 2 (10%) | |
REC per patient (mean ± SD) [range] | 2.9 ± 1.12 [1–5] | 2.65 ± 0.99 [1–4] | 0.622 | 2.78 (1.05) [1–5] |
REC maxilla n (%) | 24 (41.38%) | 22 (41.51%) | > 0.05 | 46 (41.44%) |
REC mandible n (%) | 34 (58.62%) | 31 (58.49%) | 65 (58.5%) | |
REC depth (mm) (mean ± SD) [range] | 3.69 ± 1.03 [2.25–5.5] | 3.67 ± 0.66 [2.25–4.75] | 0.968 | 3.68 ± 0.85 [2.25–5.5] |
REC width (mm) (mean ± SD) [range] | 4.15 ± 0.73 [2.75–5.5] | 3.91 ± 0.68 [2.5–5.5] | 0.289 | 4.03 ± 0.71 [2.5–5.5] |
CAL (mm) (mean ± SD) [range] | 4.88 ± 1.12 [3.33–7] | 4.95 ± 0.75 [3.25–6.5] | 0.565 | 4.91 ± 0.95 [3.25–7] |
KTW (mm) (mean ± SD) [range] | 1.78 ± 1.24 [0–5] | 1.77 ± 1.10 [0–4] | 0.968 | 1.78 ± 1.24 [0–5] |
GT (mm) (mean ± SD) [range] | 1.09 ± 0.28 [0.5–2] | 1.19 ± 0.29 [1–2] | 0.365 | 1.14 ± 0.29 [0.5–2] |
Clinical results
Grupo | T0 | T1 | T2 | T0-T1 | T0-T2 | T1-T2 | ||
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(baseline) (mean ± SD) | (6 months) (mean ± SD) | (12 months) (mean ± SD) | P intragroup | P intragroup | P intragroup | |||
RECdepth (mm) | Test (CMX) n = 20 | 3.69 ± 1.03 | 1.48 ± 0.73 | 1.55 ± 0.77 | < 0.001 | < 0.001 | 0.448 | |
Control (CTG) n = 20 | 3.68 ± 0.66 | 1.18 ± 0.88 | 1.11 ± 0.78 | 0.905 | ||||
P (intergroup) | 0.968 | 0.314 | 0.149 | - | - | - | ||
RECwidth (mm) | Test (CMX) n = 20 | 4.15 ± 0.74 | 2.83 ± 1.02 | 2.9 ± 0.94 | < 0.001 | < 0.001 | 0.866 | |
Control (CTG) n = 20 | 3.91 ± 0.69 | 2.38 ± 1.56 | 2.48 ± 1.58 | 0.767 | ||||
P (intergroup) | 0.289 | 0.478 | 0.583 | - | - | - | ||
KTW (mm) | Test (CMX) n = 20 | 1.79 ± 1.25 | 2.36 ± 2.47 | 1.96 ± 1.09 | 0.307 | 0.443 | 0.623 | |
Control (CTG) n = 20 | 1.78 ± 1.11 | 2.47 ± 1.3 | 2.43 ± 1.17 | 0.004 | 0.01 | 0.752 | ||
P (intergroup) | 0.968 | 0.301 | 0.242 | - | - | |||
CAL (mm) | Test (CMX) n = 20 | 4.88 ± 1.12 | 2.53 ± 0.78 | 2.64 ± 0.79 | < 0.001 | < 0.001 | 0.14 | |
Control (CTG) n = 20 | 4.95 ± 0.76 | 2.35 ± 0.96 | 2.28 ± 0.87 | 0.284 | ||||
P (intergroup) | 0.565 | 0.738 | 0.265 | - | - | - |
Clinical parameter | Group | T1 | T2 | P intragroup |
---|---|---|---|---|
(6 months) | (12 months) | |||
MRC (%) | Test (CMX) n = 20 | 59.60 ± 16.23 | 56.48 ± 19.68 | 0.167 |
Control (CTG) n = 20 | 68.70 ± 23.53 | 69.72 ± 21.21 | 0.378 | |
P intergroup | 0.163 | 0.048 | ||
CRC (%) | Test (CMX) n = 20 | 45 | 35 | 0.084 |
Control (CTG) n = 20 | 40 | 40 | 0.086 | |
P intergroup | 0.64 | 0.14 | ||
RECred (mm) | Test (CMX) n = 20 | 2.21 ± 0.90 | 2.14 ± 1.07 | 0.448 |
Control (CTG) n = 20 | 2.50 ± 0.84 | 2.56 ± 0.86 | 0.905 | |
P intergroup | 0.277 | 0.181 | ||
CAL gain (mm) | Test (CMX) n = 20 | 2.36 ± 0.97 | 2.64 ± 0.79 | 0.14 |
Control (CTG) n = 20 | 2.60 ± 1.10 | 2.28 ± 0.87 | 0.284 | |
P intergroup | 0.512 | 0.221 | ||
KTW gain (mm) | Test (CMX) n = 20 | 0.57 ± 2.08 | 0.18 ± 0.84 | 0.623 |
Control (CTG) n = 20 | 0.69 ± 0.85 | 0.65 ± 0.92 | 0.752 | |
P intergroup | 0.174 | 0.114 | ||
GT (mm) | Test (CMX) n = 20 | - | 0.46 ± 0.54 | - |
Control (CTG) n = 20 | - | 0.78 ±0.47 | - | |
P intergroup | - | 0.038 |
Parameter T2 | Location | CMX | CTG | p intergroup |
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MRC (%) | Maxilla (n = 9) | 65.01 ± 16.83 | 83.34 ± 15.68 | 0.015 |
Mandible (n = 11) | 49.49 ± 19.74 | 58.58 ± 18.83 | 0.141 | |
p intragroup | 0.152 | 0.007 | ||
CRC n (%) | Maxilla (n = 9) | 55.56 | 77.78 | 0.034 |
Mandible (n = 11) | 27.28 | 9.09 | 0.72 | |
p intragroup | 0.412 | 0.012 | ||
REC depth (mm) (mean ± SD) | Maxilla (n = 9) | 2.61 ± 0.97 | 3.15 ± 0.73 | 0.297 |
Mandible (n = 11) | 1.76 ± 1.06 | 2.08 ± 0.67 | 0.217 | |
p intragroup | 0.08 | 0.003 | ||
REC width (mm) (mean ± SD) | Maxilla (n = 9) | 1.6 ± 0.99 | 2.5 ± 1.48 | 0.19 |
Mandible (n = 11) | 0.97 ± 0.89 | 0.57 ± 0.78 | 0.332 | |
p intragroup | 0.147 | 0.001 | ||
KTW gain (mm) (mean ± SD) | Maxilla (n = 9) | 0.16 ± 1.09 | 0.87 ± 1.07 | 0.185 |
Mandible (n = 11) | 0.19 ± 0.63 | 0.46 ± 0.77 | 0.401 | |
p intragroup | 0.943 | 0.33 | ||
CAL gain (mm) (mean ± SD) | Maxilla (n = 9) | 2.67 ± 0.97 | 3.47 ± 0.88 | 0.222 |
Mandible (n = 11) | 1.89 ± 1.07 | 2.01 ± 1.03 | 0.562 | |
p intragroup | 0.08 | 0.004 | ||
GT gain (mm) (mean ± SD) | Maxilla (n = 9) | 0.81 ± 0.55 | 0.97 ± 0.48 | 0.481 |
Mandible (n = 11) | 0.17 ± 0.31 | 0.64 ± 0.44 | 0.034 | |
p intragroup | 0.004 | 0.135 |
The percentage of MRC was 56.48% on test and 69.72% on control sites at 12 months (p = 0.048). Between 6 and 12 months, the percentage of MRC decreased from 59.60 to 56.48% in the test group and an increased in the control group from 68.70 to 69.72%, respectively. The CRC was achieved in 7 patients (35%) in the test group and 8 patients (40%) in the control group Three patients presented with CRC for all treated recessions in the control group. At the recession level, the percentage of CRC decreased in the test group (from 15.5 to 12.1%), and in the control group, it increased from 18.9 to 22.6% from 6 to 12 months.Both treatment groups showed significant post-surgical improvement in all clinical variables, except for the KTW in the test group. The GT increased after the surgical procedures: 0.46 mm (SD:0.54) in the test group and 0.78 mm (SD:0.47) in the control group (p = 0.038).
Results of the surgical procedure and PROMs
Test (CMX) | Control (CTG) | intergroup p | ||
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N = 20 (mean ± SD) | N = 20 (mean ± SD) | |||
Surgical time (minutes) | 41 ± 7.6 | 49.15 ± 8.5 | 0.003 | |
RES | 6.74 ± 1.97 | 7.29 ± 2.24 | 0.309 | |
PROMs | ||||
VAS postoperative pain | 3.65 ± 2.08 | 5.2 ± 2.31 | 0.015 | |
VAS clinical experience | 6.4 ± 2.21 | 5.35 ± 2.08 | 0.134 | |
VAS aesthetic | 6.85 ± 1.5 | 7.15 ± 1.3 | 0.64 |
The aesthetic evaluation score at 12 months was 6.85 (SD:1.5) in the test group and 7.15 (SD:1.3) in the control group These values were similar to the RES score in the test group (6.7 (SD:1.97)) and in the control group (7.28 (SD:2.24)).