Background
Methods
Sample size calculation
Case selection
Randomization, allocation concealment of the instrumentation systems, and pretreatment instructions
Treatment protocol
Group | Protocols |
---|---|
I | Chemomechanical preparation with a rotary motion by using Profile 04 system files (Dentsply-Maillefer) driven by the X-Smart Plus electric motor (Dentsply-Maillefer) at 300 rpm with a torque setting of 2 N.cm, with a slow in-and-out pecking motion that did not exceed 3–4 mm in amplitude, according to the crown-down philosophy without IFE, i.e., the apical limit was established around the AC (-0.5 mm from the AF identified by the apex locatora as 0.0 mm). A 2.5 mL aliquot of 2.5% NaOCl was used as an irrigating solution at each file use or change, applied with a NaviTip 31 G needle (Ultradent) up to 5 mm short of the AF. The same amount of NaOCl was used for each canal (40 mL) |
II | The exact specifications described for Group I, but with IFE, i.e., the apical limit was established at 0.5 mm beyond the AF (identified by the apex locatora as 0.0 mm) |
III | Chemomechanical preparation with a reciprocating motion by using Reciproc system files (VDW) driven by the X-Smart Plus electric motor (Dentsply-Maillefer), with a slow in-and-out pecking motion that did not exceed 3–4 mm in amplitude without IFE, i.e., the apical limit was established around the AC (-0.5 mm from the AF identified by the apex locatora as 0.0 mm). A 2.5 mL aliquot of 2.5% NaOCl was used as an irrigating solution at each file use or change, applied with a NaviTip 31 G needle (Ultradent) up to 5 mm short of the AF. The same amount of NaOCl was used for each canal (40 mL) |
IV | The exact specifications described for Group III, but with IFE, i.e., the apical limit was established at 0.5 mm beyond the AF (identified by the apex locatora as 0.0 mm) |
Group I | Group II | Group III | Group IV | |||
---|---|---|---|---|---|---|
Approximate size of the AC/AF before the chemomechanical preparation (corresponding to the manual FlexoFile number) | The final file used around the AC (-0.5 mm from the AF) (tip/taper) | The final file used at 0.5 mm beyond the AF (tip/taper) | Approximate size of AC after the chemomechanical preparation | The final file used around the AC (-0.5 mm from the AF) (tip/taper) | The final file used at 0.5 mm beyond the AF (tip/taper) | Approximate size of AC after the chemomechanical preparation |
10/12 | 25/04 | 25/04 | 29 | 25/08 | 25/08 | 33 |
15/17 | 40/04 | 40/04 | 44 | 40/06 | 40/06 | 46 |
20/22 | 40/04 | 40/04 | 44 | 40/06 | 40/06 | 46 |
25/27 | 50/04 | 50/04 | 54 | 50/05 | 50/05 | 55 |
30/32 | 50/04 | 50/04 | 54 | 50/05 | 50/05 | 55 |
Analysis of postoperative pain
Score | Pain | Features |
---|---|---|
0 | No pain | No discomfort or pain |
1 | Slight pain | The patient could be distracted from feeling pain, and no analgesia was required |
2 | Moderate pain | The patient felt moderate pain even while concentrating on some other activity, and an analgesic was required |
3 | Severe pain | The patient could no longer perform any activity and needed to lie down and rest (analgesics had little or no effect on pain relief) |
Statistical analysis
Results
Groups | ||||||
---|---|---|---|---|---|---|
Variable | I (n. 60) | II (n. 60) | III (n. 60) | IV (n. 60) | Total (n. 240) | P value |
Age (mean ± standard deviation) | 40.6 ± 18.29a | 38.48 ± 16.49a | 41.37 ± 15.30a | 41.10 ± 15.4a | 40.39 ± 16.35a | 0.76 |
< 30 years-old (n. / % considering the age / % considering the group) | 22 / 27.8% / 36.7%a | 20 / 25.3% / 33.3%a | 16 / 20.3% / 26.7%a | 21 / 26.6% / 35%a | 79 / 100% / 32.9%a | |
≥ 30 and ≤ 50 years-old (n. / % considering the age / % considering the group) | 22 / 25% / 36.7%a | 22 / 25% / 36.7%a | 28 / 31.8% / 46.7%a | 16 / 18.2% / 26.7%a | 88 / 100% / 36.7%a | |
≥ 50 years-old (n. / % considering the age / % considering the group) | 16 / 21.9% / 26.7%a | 18 / 24.7% / 30%a | 16 / 21.9% / 26.7%a | 23 / 31.5% / 38.3%a | 73 / 100% / 30.4%a | |
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | |
Gender | ||||||
Male (n. / % considering the gender / % considering the group) | 27 / 26.7% / 45%a | 28 / 27.7% / 46.7%a | 22 / 21.8% / 36.7%a | 24 / 23.8% / 40%a | 101 / 100% / 42.1%a | 0.66 |
Female (n. / % considering the gender / % considering the group) | 33 / 23.7% / 55%a | 32 / 23% / 53.3%a | 38 / 27.3% / 63.3%a | 36 / 25.9% / 60%a | 139 / 100% / 57.9%a | |
Total | 60 / 25% / 100% | 60 / 25% / 100%a | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | |
Teeth | ||||||
Lower canine (n. / % considering the tooth / % considering the group) | 1 / 14.3% / 1.7%ª | 0 / 0% / 0%ª | 2 / 28.6% / 3.3%ª | 4 / 57.1% / 6.7%ª | 7 / 100% / 2.9% | < 0.00 |
Upper canine (n. / % considering the tooth / % considering the group) | 5 / 45.5% / 8.3%ª | 3 / 27.3% / 5%ª | 2 / 18.2% / 3.3%ª | 1 / 9.1% / 1.7%ª | 11 / 100% / 4.6% | |
Lower central incisor (n. / % considering the tooth / % considering the group) | 2 / 25% / 3.3%ª | 4 / 50% / 6.7%ª | 0 / 0% / 0%ª | 2 / 25% / 3.3%ª | 8 / 100% / 3.3% | |
Upper central incisor (n. / % considering the tooth / % considering the group) | 6 / 35.3% / 10%ª | 7 / 41.2% / 11.7%ª | 1 / 5.9% / 1.7%ª | 3 / 17.6% / 5%ª | 17 / 100% / 7.1% | |
Lower lateral incisor (n. / % considering the tooth / % considering the group) | 1 / 12.5% / 1.7%ª | 1 / 12.5% / 1.7%ª | 4 / 50% / 6.7%ª | 2 / 25% / 3.3%ª | 8 / 100% / 3.3% | |
Upper lateral incisor (n. / % considering the tooth / % considering the group) | 6 / 66.7% / 10%ª | 1 / 11.1% / 1.7%ª | 1 / 11.1% / 1.7%ª | 1 / 11.1% / 1.7%ª | 9 / 100% / 3.8% | |
Mandibular first molar (n. / % considering the tooth / % considering the group) | 7 / 14.9% / 11.7%ª | 8 / 17% / 13.3%ª | 27 / 57.4% / 45%b | 5 / 10.6% / 8.3%ª | 47 / 100% / 19.6% | |
Maxillary first molar (n. / % considering the tooth / % considering the group) | 11 / 40.7% / 18.3%ª | 5 / 18.5% / 8.3%ª | 5 / 18.5% / 8.3%ª | 6 / 22.2% / 10%ª | 27 / 100% / 11.3% | |
Mandibular first premolar (n. / % considering the tooth / % considering the group) | 2 / 12.5% / 3.3%ª | 2 / 12.5% / 3.3%ª | 2 / 12.5% / 3.3%ª | 10 / 62.5% / 16.7%ª | 16 / 100% / 6.7% | |
Maxillary first premolar (n. / % considering the tooth / % considering the group) | 1 / 5.9% / 1.7%ª | 6 / 35.3% / 10.0%ª | 7 / 41.2% / 11.7%ª | 3 / 17.6% / 5.0%ª | 17 / 100% / 7.1% | |
Lower second molar (n. / % considering the tooth / % considering the group) | 6 / 42.9% / 10%ª | 1 / 7.1% / 1.7%ª | 4 / 28.6% / 6.7%ª | 3 / 21.4% / 5%ª | 14 / 100% / 5.8% | |
Maxillary second molar (n. / % considering the tooth / % considering the group) | 4 / 30.8% / 6.7%ª | 4 / 30.8% / 6.7%ª | 1 / 7.7% / 1.7%ª | 4 / 30.8% / 6.7%ª | 13 / 100% / 5.4% | |
Lower second premolar (n. / % considering the tooth / % considering the group) | 5 / 19.2% / 8.3%a.b | 7 / 26.9% / 11.7%a.b | 1 / 3.8% / 1.7%b | 13 / 50% / 21.7%a | 26 / 100% / 10.8% | |
Maxillary second premolar (n. / % considering the tooth / % considering the group) | 3 / 15% / 5%a | 11 / 55% / 18.3%a | 3 / 15% / 5%a | 3 / 15% / 5%a | 20 / 100% / 8.3% | |
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | |
Periradicular status | ||||||
AAP with apical radiolucent areas (n. / % of this periradicular status considering each tooth / % of this periradicular status considering the group | 44 / 35.8% / 73.3%ª | 12 / 9.8% / 20%b | 40 / 32.5% / 66.7%a.c | 27 / 22% / 45%c | 123 / 100% / 51.3% | < 0.00 |
AAP with normal periradicular tissues (without apical radiolucent areas) (n. / % of this periradicular status considering each tooth / % of this periradicular status considering the group | 16 / 13.7% / 26.7%ª | 48 / 41% / 80%b | 20 / 17.1% / 33.3%a.c | 33 / 28.2% / 55.0%c | 117 / 100% / 48.8% | |
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | |
Overfilling/sealer extrusion | ||||||
Yes (n. / % of overfilling/sealer extrusion considering all the teeth / % of overfilling/sealer extrusion considering the group) | 3 / 4.5% / 5%a | 24 / 35.8% / 40%b | 14 / 20.9% / 23.3%b | 26 / 38.8% / 43.3%b | 67 / 100% / 27.9% | < 0.00 |
No (n. / % of overfilling/sealer extrusion considering all the teeth / % of overfilling/sealer extrusion considering the group) | 57 / 32.9% / 95%ª | 36 / 20.8% / 60%b | 46 / 26.6% / 76.7%b | 34 / 19.7% / 56.7%b | 173 / 100% / 72.1% | |
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% |
Groups | |||||||
---|---|---|---|---|---|---|---|
Time | Pain level | I | II | III | IV | Total | P value |
24 h | None (n. / % according to the pain score / % regarding the group) | 52 / 31%/ 86.7%a | 43 / 25.6% / 71.7%a.b | 38 / 22.6% / 63.3%b | 35 / 20.8% / 58.3%b | 168 / 100% / 70% | 0.02 |
Mild (n. / % according to pain score / % regarding group) | 7/ 15.6% / 11.7%ª | 8 / 17.8% / 13.3%ª | 14 / 31.1% / 23.3%ª | 16 / 35.6% / 26.7%ª | 45 / 100% / 18.8% | ||
Moderate (n. / % according to the pain score / % regarding the group) | 1/ 5.3% / 1.7%ª | 7 / 36.8% / 11.7%ª | 5 / 26.3% / 8.3%ª | 6 / 31.6% / 10%ª | 19 / 100% / 7.9% | ||
Acute/Severe (n. / % according to the pain score / % regarding the group) | 0 / 0% / 0%ª | 2 / 25% / 3.3%ª | 3 / 37.5% / 5.0%ª | 3 / 37.5% / 5%ª | 8 / 100% / 3.3% | ||
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | ||
48 h | None (n. / % according to the pain score / % regarding the group) | 55 / 27.2% / 91.7%ª | 46 / 22.8% / 76.7%ª | 51 / 25.2% / 85%ª | 50 / 24.8% / 83.3%ª | 202 / 100% / 84.2% | 0.49 |
Mild (n. / % according to pain score / % regarding the group) | 5 / 20% / 8.3%ª | 9 / 36% / 15%ª | 5 / 20% / 8.3%ª | 6 / 24% / 10%ª | 25 / 100% / 10.4% | ||
Moderate (n. / % according to the pain score / % regarding the group) | 0 / 0% / 0%ª | 4 / 36.4% / 6.7%ª | 4 / 36.4% / 6.7%ª | 3 / 27.3% / 5%ª | 11 / 100% / 4.6% | ||
Acute/Severe (n. / % according to the pain score / % regarding the group) | 0 / 0% / 0%ª | 1 / 50% / 1.7%ª | 0 / 0% / 0%ª | 1 / 50% / 1.7%ª | 2 / 100% / 0.8% | ||
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% | ||
72 h | None (n. / % according to the pain score / % regarding the group) | 57 / 26.3% / 95%ª | 53 / 24.4% / 88.3%ª | 55 / 25.3% / 91.7%ª | 52 / 24% / 86.7%ª | 217 / 100% / 90.4% | 0.27 |
Mild (n. / % according to pain score / % regarding group) | 3 / 20% / 5%ª | 3 / 20% / 5%ª | 2 / 13.3% / 3.3%ª | 7 / 46.7% / 11.7%ª | 15 / 100% / 6.3% | ||
Moderate (n. / % according to the pain score / % regarding the group) | 0 / 0% / 0%ª | 3 / 42.9% / 5%ª | 3 / 42.9% / 5%ª | 1 / 14.3% / 1.7%ª | 7 / 100% / 2.9% | ||
Acute/Severe (n. / % according to the pain score / % regarding the group) | 0 / 0% / 0%ª | 1 / 100% / 1.7%ª | 0 / 0% / 0.0%ª | 0 / 0% / 0%ª | 1 / 100% / 0.4% | ||
Total | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 60 / 25% / 100% | 240 / 100% / 100% |