PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration

Nagendrababu, Venkateshbabu; Duncan, Henry F.; Bjørndal, Lars; Kvist, Thomas; Priya, Ekta; Jayaraman, Jayakumar; Pulikkotil, Shaju Jacob; Dummer, P. M. H.

doi:10.1111/iej.13304

Cited by 23 publications

(25 citation statements)

References 68 publications

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“…The trial was reported according to the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines (Nagendrababu et al . 2020). The protocol was registered at the ClinicalTrials.gov Identifier: NCT03312153.…”

Section: Methodsmentioning

confidence: 99%

Effect of Neem (Azadirachta indica) versus 2.5% sodium hypochlorite as root canal irrigants on the intensity of post‐operative pain and the amount of endotoxins in mandibular molars with necrotic pulps: a randomized controlled trial

et al. 2021

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Aim To assess the effect of Neem versus 2.5% NaOCl as root canal irrigants on the intensity of post‐operative pain and amount of endotoxins following root canal treatment of mandibular molars with necrotic pulps. Methodology This parallel, prospective, double‐blinded, randomized controlled trial with allocation ratio 1:1 was conducted in the out‐patient clinic of the Endodontic Department, Faculty of Dentistry, Cairo University, Egypt. Fifty healthy patients with mandibular molars with necrotic pulps were randomly assigned into two equal groups using computer software. In the intervention group, root canals were irrigated using Neem; whilst 2.5% NaOCl was used in the control group. A standard root canal treatment was performed in two visits using ProTaper Next rotary files, with no intracanal medication. Pain intensity was assessed using a numerical rating scale (NRS) 6, 12, 24 and 48 h following instrumentation and canal filling. Endotoxin samples were collected using three paper points before and after canal instrumentation and a sandwich ELISA method was used to quantify the level of endotoxins. Demographic, baseline, and outcome data were collected and analysed using chi‐square tests (for the comparisons of categorical variables), Mann–Whitney tests (for non‐normally distributed variables) and Student’s t tests (for normally distributed variables), A P‐value < 0.05 was considered to be statistically significant. Results The mean pain scores within the two groups decreased continually over time. The mean pain scores in the Neem group were lower than those in the 2.5% NaOCl group at 6, 12, 24 and 48 h following instrumentation and canal filling with no significant difference between them except at 24 h following instrumentation (P = 0.012). Both irrigants significantly reduced endotoxin levels compared to the pre‐instrumentation samples (P < 0.001) by 8% for the NaOCL group and 18% for the Neem group. Conclusion Neem and 2.5% NaOCl were not significantly different in terms of reducing the intensity of post‐operative pain during all follow‐up periods except at 24 h following instrumentation where Neem was associated with lower pain intensity. Both irrigants significantly reduced endotoxin levels but were not effective in eliminating endotoxins completely from root canals of mandibular molars with necrotic pulps.

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Section: Methodsmentioning

confidence: 99%

Effect of Neem (Azadirachta indica) versus 2.5% sodium hypochlorite as root canal irrigants on the intensity of post‐operative pain and the amount of endotoxins in mandibular molars with necrotic pulps: a randomized controlled trial

et al. 2021

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“…http://ClinicalTrials.gov databases (NCT/04700995). This manuscript has been written according to PRIRATE 2020 guidelines (Nagendrababu et al, 2020). A PRIRATE flowchart sets out the key stages of the study (Figure 1).…”

Section: Methodsmentioning

confidence: 99%

The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single‐rooted incisor teeth: A randomized controlled trial

Çanakçi

Şen

et al. 2021

Int Endodontic J

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Aim This randomized clinical trial aimed to assess the effect of two rotary (ProTaper Retreatment + ProTaper Gold and Hyflex EDM) and two reciprocating (Reciproc Blue and WaveOne Gold) NiTi systems on postoperative pain after root canal retreatment on single‐rooted incisor teeth. Methodology One hundred and eighty patients scheduled for root canal retreatment were randomly assigned to one of the four groups according to the NiTi system (ProTaper Retreatment + ProTaper Gold, Hyflex EDM, Reciproc Blue or WaveOne Gold) used for the removal of root canal fillings and further canal preparation. The working length was determined to be 1 mm shorter than the ‘0.0’ mark of the apex locator. Root canals were filled with gutta‐percha and an epoxy resin‐based root canal sealer using a lateral compaction technique. The teeth were restored using a resin composite material. A single operator performed the retreatments in a single visit. The incidence and intensity of postoperative pain were rated on a numeric rating scale by patients 24, 48 and 72 h after retreatment. The number of analgesic tablets (400 mg Ibuprofen) taken by patients was also recorded. Data were analysed using the Mann–Whitney U, Wilcoxon and chi‐square tests. Results For the intensity of postoperative pain, the difference between the four groups was not significantly different (p > .05). No significant difference was found between the groups in terms of analgesic medication intake (p > .05). Conclusions The rotary and reciprocating NiTi systems tested in this study were associated with similar intensity of postoperative pain and intake of analgesics following root canal retreatment on single‐rooted incisor teeth completed in one visit.

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“…All patients who participated in the study signed an informed consent form. The study report followed the CONSORT statements (Moher et al 2012) and the Preferred Reporting Items for Randomized Trials in Endodontics (PRIRATE) (Nagendrababu et al 2020).…”

Section: Methodsmentioning

confidence: 99%

The impact of two root canal treatment protocols on the oral health‐related quality of life: a randomized controlled pragmatic clinical trial

Diniz‐de‐Figueiredo

Lima²,

Oliveira

et al. 2020

Int Endodontic J

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Aim To assess the impact of two root canal treatment protocols on the oral health‐related quality of life (OHRQoL) of patients in need of root canal treatment on their anterior teeth. Methodology The sample consisted of 120 participants (mean age: 34 years) enrolled in a pragmatic randomized clinical trial evaluating two root canal treatment protocols. Anterior teeth with nonvital pulps were allocated for root canal preparation with either hand files and filled with lateral compaction of gutta‐percha (manual protocol) or canal preparation with a single file in a reciprocating movement and filled with a single cone technique (Reciproc protocol). OHRQoL data were assessed using the Oral Health Impact Profile instrument (OHIP‐14), which was administered before the root canal intervention (baseline), and 6 and 12 months after treatment. Demographic and clinical characteristics of participants were collected at baseline. Data were analysed using bivariate analyses, Poisson univariate and multiple regression (α = 0.05). Results The drop‐out rate from baseline was 27% and 28% at 6 and 12 months after treatment, respectively. Both root canal protocols significantly enhanced patients' OHRQoL, regardless of the follow‐up time (P < 0.001). After 6 months, patients treated with the Reciproc protocol had significantly lower OHIP‐14 overall scores (P = 0.030), as well as significantly lower scores for psychological discomfort (P = 0.031) and social disability (P = 0.013). After 12 months, no significant difference was observed between the two root canal protocols for OHIP‐14 overall scores (P = 0.174). Either large or moderate effect sizes were observed for all domains and overall scores at both evaluation times, irrespective of the protocol. Low‐income persons (RR = 2.03) and the Reciproc protocol (RR = 1.52) had a higher likelihood of a positive impact on OHRQoL 12 months after root canal treatment. Conclusions The two root canal protocols improved the OHRQoL and differences in scores were observed only after 6 months with poorer OHRQoL for the manual protocol. After 12 months, patients with low‐income status and treated with Reciproc were associated with a greater improvement in OHRQoL scores.

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PRIRATE 2020 guidelines for reporting randomized trials in Endodontics: explanation and elaboration

Cited by 23 publications

References 68 publications

Effect of Neem (Azadirachta indica) versus 2.5% sodium hypochlorite as root canal irrigants on the intensity of post‐operative pain and the amount of endotoxins in mandibular molars with necrotic pulps: a randomized controlled trial

Effect of Neem (Azadirachta indica) versus 2.5% sodium hypochlorite as root canal irrigants on the intensity of post‐operative pain and the amount of endotoxins in mandibular molars with necrotic pulps: a randomized controlled trial

The effect of two rotary and two reciprocating NiTi systems on postoperative pain after root canal retreatment on single‐rooted incisor teeth: A randomized controlled trial

The impact of two root canal treatment protocols on the oral health‐related quality of life: a randomized controlled pragmatic clinical trial

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