|Year : 2017 | Volume
| Issue : 2 | Page : 124-130
Comparative evaluation of postoperative pain after single visit endodontic treatment using ProTaper Universal and ProTaper Next rotary file systems: A randomized clinical trial
Neha Arora, Sonal Bakul Joshi
Department of Conservative Dentistry and Endodontics, KLE V. K. Institute of Dental Sciences, Belagavi, Karnataka, India
|Date of Web Publication||30-May-2017|
Department of Conservative Dentistry and Endodontics, KLE V. K. Institute of Dental Sciences, Belagavi, Karnataka
Source of Support: None, Conflict of Interest: None
Introduction: Root canal preparation may cause inadvertent apical extrusion of debris causing postoperative pain. This debris varies with the instrumentation technique and design characteristics. One of the major revolutions in the design of the instruments is the introduction of files with an offset center of mass or/and rotation, which causes asymmetric rotary motion in the canal. An example is the ProTaper Next (PTN) rotary file system. In vitro studies have shown that this system extrudes lesser debris than more commonly used ProTaper Universal (PTU). However, in clinical circumstances, periapical tissues may act as a natural barrier and host immune response may affect the response. Hence, the aim of the present study was to evaluate and compare the postoperative pain after single visit endodontic treatment using PTU and PTN rotary file systems.
Study Design: A total of 80 patients were assigned to two groups according to the root canal instrumentation technique used, PTU or PTN. Root canal treatment was carried out in a single appointment, and the severity of postoperative pain was assessed using visual analog scale score after 6, 24, 48, and 72 h. The association of variables (age and sex) and root canal preparation time were also evaluated and compared between the groups.
Results: Postoperative pain was significantly higher in PTU group than PTN group. The highest pain was observed at 6 h interval which reduced with each time with no pain at 72 h interval in both the groups. Significantly, more amount of time was involved with PTU as compared to PTN. A significantly higher pain was observed with advancing age and in females.
Conclusion: The postoperative pain was significantly higher in patients undergoing canal instrumentation with PTU rotary instruments as compared to the PTN rotary instruments.
Keywords: Postoperative pain, ProTaper Next, ProTaper Universal, single visit endodontics
|How to cite this article:|
Arora N, Joshi SB. Comparative evaluation of postoperative pain after single visit endodontic treatment using ProTaper Universal and ProTaper Next rotary file systems: A randomized clinical trial. Indian J Health Sci Biomed Res 2017;10:124-30
|How to cite this URL:|
Arora N, Joshi SB. Comparative evaluation of postoperative pain after single visit endodontic treatment using ProTaper Universal and ProTaper Next rotary file systems: A randomized clinical trial. Indian J Health Sci Biomed Res [serial online] 2017 [cited 2017 Oct 18];10:124-30. Available from: http://www.ijournalhs.org/text.asp?2017/10/2/124/207258
| Introduction|| |
The increase in the lifespan of the individuals and higher success rates in endodontics have widened the scope of endodontics. Today, extraction of the teeth has become a rarity and endodontic intervention a norm. Even with a better understanding of the internal tooth anatomy, evolution of instruments and materials and a greater know-how regarding techniques for treatment modalities, complications do surface. Postoperative pain, which is an undesirable complication, is frequently encountered and found to range between 3% and 58% in root canal treatment.
This postoperative pain is dependent on many factors that include host-dependent factors such as host immunity, history of preoperative pain, and occlusal trauma or operator-dependent factors such as chemical, mechanical, or bacterial injury during root canal preparation. Of these, inadvertent extrusion of dentin chips, microorganisms, pulpal tissue remnants, or necrotic debris into the periapical region during preparation forms a major factor of postoperative pain. This debris varies with the instrumentation technique and the instrument per se Therefore, an instrument that extrudes minimal debris into the periapical area, thus causing lesser pain, is desirable.
Over the decades, research has led to a full sequence, variable taper rotary instrument, that is, ProTaper Universal (PTU) by Dentsply-Maillefer (Ballaigues, Switzerland). This system has shown encouraging results in terms of shaping ability. However, its disadvantages include the increased number of instruments, learning curve, and instrument fatigue.
The newer fifth generation of files has been designed such that the center of mass and/or the center of rotation are offset. This produces a mechanical wave of motion that travels along the active length of the file, minimizing the engagement of file to the root dentin ProTaper Next (PTN) (Dentsply-Maillefer, Ballaigues, Switzerland) is an example of this generation.
In vitro studies have shown that the PTN extruded lesser debris as compared to the conventional and more commonly used PTU. However, in clinical circumstances, periapical tissues may act as a natural barrier, positive and negative pressure at the apex, normal or pathological periapical tissues, immature root development, and open apices affect debris extrusion. Furthermore, the host immune response could affect the presentation of postoperative pain. A randomized clinical trial evaluating the two abovementioned systems with respect to the postoperative pain was aimed for as it provides the highest level of support for evidence-based clinical practice.
Endodontic treatment could be offered in single or multiple visits. Single visit endodontic treatment with its advantages such as reduction in the number of operative procedures, no risk of inter-appointment leakage, lesser time, relatively inexpensive, and decreased overall postoperative pain has taken over multiple visit treatment in recent times as the preferred modality.
Hence, a study aimed at evaluating and comparing the postoperative pain after single visit endodontic treatment using PTU and PTN rotary file systems has been conducted.
To evaluate and compare the postoperative pain after single visit endodontic treatment using PTU and PTN rotary file systems in a randomized clinical trial.
| Materials and Methods|| |
This randomized clinical trial was conducted in the Department of Conservative Dentistry and Endodontics, KLE V. K. Institute of Dental Sciences, Belagavi, Karnataka. This study was approved by the Research and Ethical Committee, KLE University's V K Institute of Dental Sciences (Reg. No 906; Dated: 30th October 2014).
Eighty patients in the age group 18–50 years, taking into account 10% dropouts if present, requiring endodontic treatment on asymptomatic permanent maxillary premolar teeth diagnosed as vital using pulp sensitivity tests were selected for the study from the regular pool of patients. The procedure was explained to the patient in his/her own language, and a written informed consent was obtained.
Important prognostic determinants of postoperative pain such as age and gender were recorded. A single clinician evaluated and treated all patients. Patients were divided into two groups using table of random numbers.
Local anesthesia (2% lignocaine 1:80,000 adrenaline) (Xicaine, ICPA Health Products Ltd., Ankleshwar, Gujarat, India) was administered and rubber dam applied (Hygienic, Coltene/Whaledent). The tooth was then disinfected with Möller's procedure.
Access cavity was prepared and canal patency checked by #10 K-file. (Mani Inc., Japan). The working length was determined using DentaPort ZX (J. Morita Mfg. Corp., Kyoto, Japan) and confirmed with radiograph. Glide path was created by #15 K-file (Mani Inc., Tochigi, Japan).
Subsequently, root canal preparation was accomplished by one of the following two instrumentation systems, in Group A (n = 40) with full-sequence rotary PTU files up to size F2 (25/08) and in Group B (n = 40) PTN files up to size X2 (25/06) according to the manufacturer's instructions.
Irrigation was performed with 3% NaOCl, 17% ethylenediaminetetraacetic acid, and 0.9% normal saline according to protocol suggested by Schafer et al.
Master cone radiograph was taken and both groups were obturated with single cone obturation technique with an epoxy resin based sealer (AH Plus ® Sealer (Dentsply DeTrey, Konstanz, Germany)). Temporary restoration (Cavit G, 3M ESPE Dental-Medizin GmbH Co, Seafeld, Germany) was given and postobturation IOPAR was taken.
Time for canal preparation was measured from the first file that was used to check canal patency till the last file that was used to instrument the canal.
The patients were instructed to take mild analgesic (400 mg ibuprofen), if they experienced pain. The presence or absence of postoperative pain, or the appropriate degree of pain was recorded as none, slight, moderate, or severe, using a modified visual analog scale (VAS), validated in previous studies:
- No pain (0): The treated tooth felt normal. Patients did not have any pain
- Mild pain (1): Recognizable, but not discomforting, pain, which required no analgesics
- Moderate pain (2): Discomforting, but bearable, pain (analgesics, if used, were effective in relieving the pain)
- Severe pain (3): Difficult to bear (analgesics had little or no effect in relieving the pain).
The amount of analgesic, if taken, was recorded at that particular time interval. The patients were instructed to call the clinic if adequate pain relief was not obtained with the prescription.
Statistical analysis was performed using SPSS software (IBM SPSS Statistics for Windows, Version 20.0. Armonk, NY: IBM Corp ).
- Intergroup pairwise comparison with VAS scores at different time points was carried out using Man–Whitney U-test
- Intragroup pairwise comparison with VAS scores at different time points was carried out using Wilcoxon matched pairs test
- To assess the association of variables (age and sex) with VAS scores, Chi-square test was used
- The time required for instrumentation of the canals in both groups was compared using independent t-test.
| Results|| |
At the end of 6 h, although not statistically significant (P = 0.1021), higher VAS scores were observed in Group A than Group B, which were clinically significant. A statistically significant difference was observed with VAS scores between Groups A and B at the end of 24 h (P = 0.0133) and 48 h (P = 0.0493) with higher VAS scores observed in Group A [Table 1] and [Figure 1].
|Table 1: Comparison of Group A and Group B with visual analog scale scores at different time points using Mann-Whitney U-test|
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|Figure 1: Comparison of Group A and Group B with visual analog scale scores at different time points|
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In group A, a statistically significant difference (P< 0.05) was observed between the VAS scores at all time periods 6 h versus 24 h, 6 h versus 48 h, 6 h versus 72 h, 24 h versus 48 h, 24 h versus 72 h, 48 h versus 72 h [Table 2].
|Table 2: Intra-group (Group A) pairwise comparison of visual analog scale scores at 6, 24, 48, and 72 h by Wilcoxon matched pairs test|
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In group B, a statistically significant difference (P< 0.05) was observed between the VAS scores at time periods 6 h versus 24 h, 6 h versus 48 h, 6 h versus 72 h, 24 h versus 48 h, 24 h versus 72 h [Table 3].
|Table 3: Intra-group (Group B) pairwise comparison of visual analog scale scores at 6, 24, 48, and 72 h by Wilcoxon matched pairs test|
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The canal preparation time was significantly shorter in the Group B in comparison with the Group A (5.49 ± 1.06 min vs. 11.28 ± 1.72 min) [Table 4] and [Figure 2].
|Table 4: Comparison of two study groups (Group A and Group B) with mean time by independent t-test|
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| Discussion|| |
Evolution is the way of life and endodontics is not untouched by it. Manufacturers and researchers have readily come up with newer file systems utilizing the most proven design features from the past and adding to it the most recent technological advancement available, to produce safer, more efficient, and simpler file systems.
However, it has been observed that all instrumentation techniques, either manual or mechanical cause inadvertent extrusion of debris into the periapex.
This debris may include dentinal chips, microorganisms, pulpal tissue remnants, irrigating solutions, or necrotic tissue. Extrusion of this debris causes injury resulting in inflammation.
However, it has also been observed that some instruments and instrumentation techniques extrude lesser debris than others. Thus, causing lesser postoperative pain.
This postoperative pain affects the patient's quality of and in turn serves as a benchmark to judge the clinician's skill. Hence, postendodontic pain is an undesirable occurrence for even the clinicians.
The design of the root canal instrument has been determined to be the most influential factor for neuropeptide expression after root canal preparation, regardless of the number of files or the type of movement. There is a plethora of research in the design of the instrument to decrease this postoperative pain.
There has been a revolution in the alloy used for manufacturing these instruments too. The progression from manual to the mechanical usage of NiTi instruments in a rotary motion revolutionized the way root canals were treated.
The clinical effectiveness of the files increased manifold through the introduction of thermomechanically treated NiTi file systems such as M-Wire, R-phase, controlled memory, and gold wire.
Another major advancement was the introduction of reciprocating motion. However, it was shown to extruded more debris apically than files in continuous motion.
Thus, continuous research is going on in terms of their designs, alloy types, and the motions employed to accomplish an ideal preparation with predictability and minimal postoperative pain.
One of the results of the continuous research was a progressively tapered design in a single file. This design has been shown to significantly improve flexibility, cutting efficiency, and safety. The full sequence PTU system is an example of such a design. It is one of the most commonly used rotary NiTi systems. This system has shown encouraging results in terms of its shaping ability. Its disadvantages include the use of increased number of instruments, increased learning curve, increased fatigue, and increased treatment time.
The newer fifth generation of rotary files has been designed such that the center of mass and/or the center of rotation are offset. Such a design produces a mechanical wave of motion that travels along the active length of the file further minimizing the engagement of file to the root dentin  PTN is an example of this generation.
In vitro studies have concluded that PTN files were associated with significantly lesser apical debris extrusion as compared to PTU system. However, the results of in vitro (simulated) studies cannot be directly extrapolated to the clinical situations. In clinical circumstances, dental pulp, and periapical tissues may act as a natural barrier for extrusion of this debris.
A common difficulty encountered in studying pain is the patient's subjective evaluation of pain. Therefore, the design of the questionnaire is critical, and it must be fully understood by the patients and easily interpreted by statisticians and researchers. For rating the intensity of pain, a modified VAS was selected as it has been recommended in a report of Cochrane database of systematic reviews for postendodontic pain. They suggest that the level of discomfort/pain must be rated in categories arranged in advanced order and exactly described with the use of analgesics. Thus, making it accurate criteria for quantifying pain.
Nonsteroidal anti-inflammatory drugs, especially Ibuprofen has been recommended as first choice medication for postoperative pain management after endodontic treatment.
The results obtained in this study indicate that the postoperative pain obtained after root canal instrumentation with PTU rotary file system (Group A) was consistently higher than in instrumentation with PTN system (Group B). Hence, the null hypothesis was rejected.
Koçak et al., Ozsu et al. and Capar et al. in their in vitro studies have found that PTU extruded more debris apically as compared to PTN. As the postoperative pain after endodontic treatment is strongly implicated to the apical extrusion of debris, we can conclude that these results are similar to the abovementioned studies.
The design of PTN file system boasts of an off-centered rectangular cross section resulting in only two point contact to the root canal wall at a time. The axis of rotation in the PTN system differs from the center of mass. The offset design of the PTN system along with its swaggering motion in the canal could have enhanced the augering of debris out of the canal coronally rather in the apical direction., Thus, causing lesser postoperative pain.
As there were more number of files (five) in PTU group (Group A) as compared to three files only in PTN (Group B), the file insertion time increased leading to more debris produced and compacted tightly along dentine walls which made it difficult to be flushed out of the canal.
In addition, the larger taper in PTU F2 file (8%) (Group A) as compared to PTN X2 (Group B) which has only 6% taper, could result in more aggressive cutting, thus more debris production.
The thermomechanical treatment results in an increase in flexibility of the PTN files (M-wire) due to which it maintains the canal curvature well, causing lesser canal transportation than PTU (conventional NiTi). Maintaining the canal curvature well has been shown to result in lesser iatrogenic defects and thus lesser potential to create and extrude debris and thus, lesser postoperative pain.
The difference between postoperative pain between Group A (PTU) and B (PTN) at 6 h was, however, not significant. This could be first attributed to the in vivo, controlled and randomized study design. Another major factor could be the “Hawthorne effect.” This effect refers to the change in behavior of a subject because of the special attention and status received from participation in an investigation which could provoke them to overestimate their pain levels initially causing an apparent discordance until a day has passed.
In the results of this study, a pattern was also seen regarding the intensity of pain experienced by patients within the group wherein the greatest intensity of pain, if any, was recorded 6 h after the therapy, and afterward it decreased continuously (statistically significant, P< 0.05) resulting in no pain at all in both the groups at 72 h.
These results are similar to the results obtained by Kherlakian et al. and Relvas et al. Apart from the Hawthorne effect another possible reason attributable to this result, is the wearing off of the local anesthetic effect in the immediate 6 h following the endodontic procedure. In addition to this, the glide path establishment before rotary instrumentation, as followed in this study, has been shown to result in less postoperative pain and faster symptom resolution.
There was no pain seen at the 72 h follow-up in either of the groups. This is in accordance with previous studies that state that postendodontic pain, if present, lasts <72 h.
Furthermore, because the active time of canal preparation required when using an instrumentation system is an important factor considered by most clinicians because of its impact on patient's overall comfort and time available for irrigation, the preparation time of each of the evaluated instrumentation systems was also calculated.
In this study, it was observed that the difference in the canal preparation time was highly significant. The time required was much more in Group A (PTU) in comparison with the Group B (PTN) (11.28 ± 1.72 min vs. 5.493 ± 1.06 min, P< 0.001). The results are similar to a study by Bürklein et al. This could be due to the difference in a number of files used, that is, five for PTU group on comparison with only three for PTN group. Another possible explanation could be off-centered rectangular cross section of PTN files. Such a modification in the cross-section involves a reduction of the contact area with the canal and therefore, results in higher cutting efficiency resulting in less time required for preparation.
In the present study, it was observed that as the age advanced among the samples, the severity of pain also increased. These results are similar to Ali et al. This may be because of less pain tolerance, less blood flow, and delayed healing.
In this study, it was observed that the female patients experienced more pain as compared to their male counterparts. These results are similar to Ali et al. This could be attributed to fluctuating female hormone levels.
The ultimate success in endodontics cannot be correlated directly to postoperative pain. The success and failure of endodontic treatment are determined by long-term results and not the presence or absence of short-term postoperative pain.
It should be noted that the results of this one clinical study cannot be generalized to all clinical cases, and more such studies with a larger sample size and association of more number of variables are required. Future research comparing the postoperative pain after root canal preparation experienced by symptomatic patients is suggested.
| Conclusion|| |
Within the limitations of this study, the following conclusions were drawn:
- Highest intensity of pain was observed at 6 h after the treatment, after which the intensity of pain decreased in both the groups, with no pain observed at 72 h follow-up
- Postoperative pain was significantly higher in patients undergoing root canal instrumentation with the PTU rotary instruments than PTN file system at the end of 24 and 48 h
- The canal preparation time was significantly lesser in the PTN group than the PTU group.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3], [Table 4]