Advertisement

CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review

Published:August 02, 2021DOI:https://doi.org/10.1016/j.joen.2021.07.017

      Abstract

      Introduction

      This study aimed to investigate methodological quality of clinical trials in regenerative endodontics and its compliance with the CONSORT statement.

      Methods

      An electronic search was performed in 8 electronic databases. Only clinical trials whose participants underwent regenerative endodontic treatment on necrotic permanent immature teeth were included. Quality assessment was performed using the Cochrane Collaboration’s Risk of Bias Tool (RoB, version 2.0). Compliance of articles with the CONSORT guidelines was assessed by a tool with scales: 0 = no description, 1 = deficient, and 2 = adequate description, totaling a maximum score of 32 points. The Mann-Whitney and Kruskal-Wallis tests were used to compare the scores among journals, studies, country, income levels, and publication periods. Spearman correlation analyses were performed between CONSORT compliance scores and 2019 journal CiteScore values, publication year, and quality assessment.

      Results

      Twenty studies were included. The average CONSORT compliance score was 20.95 (±6.19). The better reported items were the description of the interventions performed in the trials (100%), followed by the description of the number of patients analyzed, losses and exclusions (90%), and the hypothesis tested (85%). Within the 20 studies, 3 articles were classified as “low risk of bias,” 8 studies were classified as “some concerns,” and 9 studies were considered “high risk of bias.” Studies carried out in countries with higher income levels presented higher CONSORT scores. Significant moderate correlations were found between the CONSORT score and the percentage of risk of bias in low-risk domains (rs = 0.63; 95% CI, 0.31–0.94; P = .003) and the overall risk of bias categories (rs = 0.76; 95% CI, 0.54–0.98; P = .001).

      Conclusions

      The adequacy of reporting based on the CONSORT checklist items of regenerative endodontic trials was low with a moderate to high risk of bias.

      Key Words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Journal of Endodontics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Hargreaves K.M.
        • Geisler T.
        • Henry M.
        • et al.
        Regeneration potential of the young permanent tooth: what does the future hold?.
        Pediatr Dent. 2008; 30: 253-260
        • Cvek M.
        Prognosis of luxated non-vital maxillary incisors treated with calcium hydroxide and filled with gutta-percha. A retrospective clinical study.
        Endod Dent Traumatol. 1992; 8: 45-55
        • Hargreaves K.M.
        • Diogenes A.
        • Teixeira F.B.
        Treatment options: biological basis of regenerative endodontic procedures.
        Pediatr Dent. 2013; 35: 129-140
        • Torabinejad M.
        • Nosrat A.
        • Verma P.
        • et al.
        Regenerative endodontic treatment or mineral trioxide aggregate apical plug in teeth with necrotic pulps and open apices: a systematic review and meta-analysis.
        J Endod. 2017; 43: 1806-1820
        • Diogenes A.
        • Ruparel N.B.
        • Shiloah Y.
        • et al.
        Regenerative endodontics: a way forward.
        J Am Dent Assoc. 2016; 147: 372-380
        • Conde M.C.M.
        • Chisini L.A.
        • Sarkis-Onofre R.
        • et al.
        A scoping review of root canal revascularization: relevant aspects for clinical success and tissue formation.
        Int Endod J. 2017; 50: 860-874
        • Hargreaves K.M.
        • Diogenes A.
        • Teixeira F.B.
        Treatment options: biological basis of regenerative endodontic procedures.
        J Endod. 2013; 39: S30-S43
        • Ribeiro J.S.
        • Münchow E.A.
        • Ferreira Bordini E.A.
        • et al.
        Antimicrobial therapeutics in regenerative endodontics: a scoping review.
        J Endod. 2020; 46: S115-S127
        • Tricco A.C.
        • Lillie E.
        • Zarin W.
        • et al.
        A scoping review on the conduct and reporting of scoping reviews.
        BMC Med Res Methodol. 2016; 16: 15
        • Lopes L.B.
        • Neves J.A.
        • Botelho J.
        • et al.
        Regenerative endodontic procedures: an umbrella review.
        Int J Environ Res Public Health. 2021; 18: 754
        • Peters MDJ G.C.
        • McInerney P.
        • Munn Z.
        • et al.
        Chapter 11: Scoping Reviews (2020 version).
        in: Aromataris E. Munn Z. JBI Manual for Evidence Synthesis. JBI, Adelaide2020
        • Tricco A.C.
        • Lillie E.
        • Zarin W.
        • et al.
        PRISMA Extension for Scoping Reviews (PRISMA-ScR): checklist and explanation.
        Ann Intern Med. 2018; 169: 467-473
        • Munn Z.
        • Aromataris E.
        • Tufanaru C.
        • et al.
        The development of software to support multiple systematic review types: the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI).
        Int J Evid Based Healthc. 2019; 17: 36-43
        • Reis A.
        • de Geus J.L.
        • Wambier L.
        • et al.
        Compliance of randomized clinical trials in noncarious cervical lesions with the CONSORT statement: a systematic review of methodology.
        Oper Dent. 2018; 43: E129-E151
        • Sterne J.A.C.
        • Savović J.
        • Page M.J.
        • et al.
        RoB 2: a revised tool for assessing risk of bias in randomised trials.
        Bmj. 2019; 366: l4898
        • Rizk H.M.
        • Salah Al-Deen M.S.M.
        • Emam A.A.
        Comparative evaluation of Platelet Rich Plasma (PRP) versus Platelet Rich Fibrin (PRF) scaffolds in regenerative endodontic treatment of immature necrotic permanent maxillary central incisors: A double blinded randomized controlled trial.
        Saudi Dent J. 2020; 32: 224-231
        • ElSheshtawy A.S.
        • Nazzal H.
        • El Shahawy O.I.
        • et al.
        The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial.
        Int Endod J. 2020; 53: 905-921
        • El Mekkawi A.E.R.O.
        • Kataia M.A.E.R.
        • Ali M.M.
        • et al.
        Evaluation of the efficacy of diode laser in maturogenesis of immature teeth with necrotic pulps: An in vivo study “part one”.
        Indian J Public Health Res Dev. 2020; 11: 1398-1403
        • Ulusoy A.T.
        • Turedi I.
        • Cimen M.
        • et al.
        Evaluation of blood clot, platelet-rich plasma, platelet-rich fibrin, and platelet pellet as scaffolds in regenerative endodontic treatment: a prospective randomized trial.
        J Endod. 2019; 45: 560-566
        • Rizk H.M.
        • Al-Deen M.S.S.
        • Emam A.A.
        Regenerative endodontic treatment of bilateral necrotic immature permanent maxillary central incisors with platelet-rich plasma versus blood clot: a split mouth double-blinded randomized controlled trial.
        Int J Clin Pediatr Dent. 2019; 12: 332-339
        • Ragab R.A.
        • Lattif A.
        • Dokky N.
        Comparative study between revitalization of necrotic immature permanent anterior teeth with and without platelet rich fibrin: a randomized controlled trial.
        J Clin Pediatr Dent. 2019; 43: 78-85
        • Mittal N.
        • Parashar V.
        Regenerative evaluation of immature roots using PRF and artificial scaffolds in necrotic permanent teeth: a clinical study.
        J Contemp Dent Pract. 2019; 20: 720-726
        • Aly M.M.
        • Taha S.E.E.
        • El Sayed M.A.
        • et al.
        Clinical and radiographic evaluation of Biodentine and Mineral Trioxide Aggregate in revascularization of non-vital immature permanent anterior teeth (randomized clinical study).
        Int J Paediatr Dent. 2019; 29: 464-473
        • Santhakumar M.
        • Yayathi S.
        • Retnakumari N.
        A clinicoradiographic comparison of the effects of platelet-rich fibrin gel and platelet-rich fibrin membrane as scaffolds in the apexification treatment of young permanent teeth.
        J Indian Soc Pedod Prev Dent. 2018; 36: 65-70
        • Shivashankar V.Y.
        • Johns D.A.
        • Maroli R.K.
        • et al.
        Comparison of the effect of PRP, PRF and induced bleeding in the revascularization of teeth with necrotic pulp and open apex: a triple blind randomized clinical trial.
        J Clin Diagn Res. 2017; 11: Zc34-Zc39
        • Lin J.
        • Zeng Q.
        • Wei X.
        • et al.
        Regenerative endodontics versus apexification in immature permanent teeth with apical periodontitis: a prospective randomized controlled study.
        J Endod. 2017; 43: 1821-1827
        • Jiang X.
        • Liu H.
        • Peng C.
        Clinical and radiographic assessment of the efficacy of a collagen membrane in regenerative endodontics: a randomized, controlled clinical trial.
        J Endod. 2017; 43: 1465-1471
        • Botero T.M.
        • Tang X.
        • Gardner R.
        • et al.
        Clinical evidence for regenerative endodontic procedures: immediate versus delayed induction?.
        J Endod. 2017; 43: S75-S81
        • Alagl A.
        • Bedi S.
        • Hassan K.
        • et al.
        Use of platelet-rich plasma for regeneration in non-vital immature permanent teeth: clinical and cone-beam computed tomography evaluation.
        J Int Med Res. 2017; 45: 583-593
        • Narang I.
        • Mittal N.
        • Mishra N.
        A comparative evaluation of the blood clot, platelet-rich plasma, and platelet-rich fibrin in regeneration of necrotic immature permanent teeth: a clinical study.
        Contemp Clin Dent. 2015; 6: 63-68
        • Bezgin T.
        • Yilmaz A.D.
        • Celik B.N.
        • et al.
        Efficacy of platelet-rich plasma as a scaffold in regenerative endodontic treatment.
        J Endod. 2015; 41: 36-44
        • Nagy M.M.
        • Tawfik H.E.
        • Hashem A.A.
        • et al.
        Regenerative potential of immature permanent teeth with necrotic pulps after different regenerative protocols.
        J Endod. 2014; 40: 192-198
        • Nagata J.Y.
        • Gomes B.P.
        • Rocha Lima T.F.
        • et al.
        Traumatized immature teeth treated with 2 protocols of pulp revascularization.
        J Endod. 2014; 40: 606-612
        • Nagata J.Y.
        • Soares A.J.
        • Souza-Filho F.J.
        • et al.
        Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization.
        J Endod. 2014; 40: 778-783
        • Jadhav G.
        • Shah N.
        • Logani A.
        Revascularization with and without platelet-rich plasma in nonvital, immature, anterior teeth: a pilot clinical study.
        J Endod. 2012; 38: 1581-1587
        • Sarkis-Onofre R.
        • Poletto-Neto V.
        • Cenci M.S.
        • et al.
        Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry.
        J Dent. 2017; 58: 54-59
        • Loguercio A.D.
        • Maran B.M.
        • Hanzen T.A.
        • et al.
        Randomized clinical trials of dental bleaching - Compliance with the CONSORT Statement: a systematic review.
        Braz Oral Res. 2017; 31: e60
        • Iwaya S.I.
        • Ikawa M.
        • Kubota M.
        Revascularization of an immature permanent tooth with apical periodontitis and sinus tract.
        Dent Traumatol. 2001; 17: 185-187
        • Chrepa V.
        • Joon R.
        • Austah O.
        • et al.
        Clinical outcomes of immature teeth treated with regenerative endodontic procedures-A San Antonio study.
        J Endod. 2020; 46: 1074-1084
        • Unnebrink K.
        • Windeler J.
        Intention-to-treat: methods for dealing with missing values in clinical trials of progressively deteriorating diseases.
        Stat Med. 2001; 20: 3931-3946
        • Saint-Mont U.
        Randomization does not help much, comparability does.
        PLoS One. 2015; 10: e0132102
        • American Association of Endodontists AAE
        Scope of Endodontics: Regenerative Endodontics.
        AAE Position Statement Regenerative Endodontics Committee, Chicago2018: 3
        • Göstemeyer G.
        • Levey C.
        The problem: relevance, quality, and homogeneity of trial designs, outcomes, and reporting.
        Monogr Oral Sci. 2018; 27: 146-154
        • Saltaji H.
        • Armijo-Olivo S.
        • Cummings G.G.
        • et al.
        Randomized clinical trials in dentistry: Risks ofbias, risks of random errors, reporting quality, and methodologic quality over the years 1955-2013.
        PLoS One. 2017; 12: e0190089
        • Sarkis-Onofre R.
        • Poletto-Neto V.
        • Cenci M.S.
        • et al.
        CONSORT endorsement improves the quality of reports of randomized clinical trials in dentistry.
        J Clin Epidemiol. 2020; 122: 20-26
        • Schulz K.F.
        • Altman D.G.
        • Moher D.
        CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials.
        Open Med. 2010; 4: e60-e68
        • Broglio K.
        Randomization in clinical trials: permuted blocks and stratification.
        JAMA. 2018; 319: 2223-2224
        • Pandis N.
        • Polychronopoulou A.
        • Eliades T.
        An assessment of quality characteristics of randomised control trials published in dental journals.
        J Dent. 2010; 38: 713-721
        • Schulz K.F.
        • Grimes D.A.
        Blinding in randomised trials: hiding who got what.
        Lancet. 2002; 359: 696-700
        • Hua F.
        • Walsh T.
        • Glenny A.M.
        • et al.
        Surveys on reporting guideline usage in dental journals.
        J Dent Res. 2016; 95: 1207-1213
        • Nagendrababu V.
        • Duncan H.F.
        • Bjørndal L.
        • et al.
        Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) guidelines: a development protocol.
        Int Endod J. 2019; 52: 974-978
        • Fang X.
        • Hua F.
        • Riley P.
        • et al.
        Abstracts of published randomised controlled trials in endodontics: reporting quality and spin.
        Int Endod J. 2020; 53: 1050-1061