CONSORT Randomized Clinical TrialEffect of the Simultaneous Working Length Control during Root Canal Preparation on Postoperative Pain
Section snippets
Design
The design of this study was a parallel-group, randomized, controlled trial with 2 arms.
A total of 44 patients were selected for this in vivo study. The study subjects were recruited from a pool of patients referred to the department of endodontics for root canal treatment from July 2016 to December 2016. The research ethics committee (2016-73) approved the protocol. Each patient was informed about the study and signed the informed consent form.
First, a pilot study was conducted on 16 patients.
Statistical Analysis
The homogeneity of variances for homogeneity and Kolmogorov-Smirnov for normality were conducted. Data on age, preoperative pain, and pain on preoperative percussion were normally distributed and homogeneous (P > .05); thus, these data were analyzed with an independent samples t test. However, pain on postoperative percussion and postoperative pain level on days 1, 3, 5, and 7 were not normally distributed and homogeneous (P < .05). Thus, these data were analyzed with the Mann-Whitney U test.
Results
Two patients were lost during follow-up (1 patient from the control group and 1 patient from the simultaneous length control during root canal preparation group) (Fig. 2). Demographic data, preoperative and postoperative pain levels, and pain levels on percussion according to the groups are shown in Table 1. No statistically significant differences were found between the groups in terms of demographic data (age, gender, tooth number) (P > .05). According to the statistical analysis, no
Discussion
When using conventional electronic apex locators, the working length is determined after coronal flaring. A stopper is generally used to fix the working length during instrumentation. However, the protection of the working length from deviations can be achieved manually by observing the stopper and coronal reference points. The Gold Reciproc motor allows for simultaneous length control during instrumentation, and the motor automatically controls the working length by stopping the
Weaknesses of the Study
Simultaneous length control during root canal preparation group resulted in lower postoperative pain levels on all days compared with the control group; only the differences on day 1 were statistically significant. However, statistically significant differences would be expected with a large sample-size study. Moreover, in the present study, the applications could not be blinded. However, the statistical analysis was blinded.
Strengths of the Study
The design of the present study was a randomized, controlled clinical trial with 2 arms. The patients were randomly distributed into 2 groups. Thus, the best evidence was provided (Level 1 evidence). Another strength of the present study was the standardization. Only molar teeth were treated by only 1 operator. Moreover, the sample size was determined according to the effect size obtained from the data of a pilot study.
Conclusion
Within the limitations of the present study, the group with simultaneous length control during root canal preparation resulted in lower postoperative pain levels on day 1 than did the control group, and no patient needed postoperative analgesics in the group with simultaneous length control during root canal preparation. Thus, it seems that simultaneous length control during root canal preparation as a non-pharmacologic strategy for reducing postoperative pain is a beneficial technique for
Acknowledgments
The authors deny any conflicts of interest related to this study.
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2021, Prostaglandins and Other Lipid MediatorsCitation Excerpt :Ethical approval was granted by the committee ‘the Ethical Committee of the Faculty of Dentistry, University of A’ (Decision no. 2018-64) and all participants signed an informed consent form prior to treatment. The sample size was calculated using the GPower program (Franz Faul, University of Kiel, Germany) based on the data obtained from a previous study that had evaluated post-operative endodontic pain [11]. The results showed that 15 patients were sufficient per group (α = 0.05, power = 0.8, effect size = 0.944).
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