Bioactive tricalcium silicate compared to calcium hydroxide as an indirect pulp capping material for primary teeth: a systematic review and meta-analysis

Background: Several clinical trials have assessed the effectiveness of Tricalcium Silicate and Resin-based Tricalcium Silicate as an indirect pulp capping material in primary teeth. This systematic review aimed to assess the evidence presented in these trials. Methods: Five electronic databases (PubMed, Scopus, ClinicalTrials.gov, ScienceDirect, and Cochrane) were utilized to search for studies published up to July 2025, with no restrictions on the publication date. A search of the gray literature was also conducted via Google Scholar. The search strategies were structured using the P (population) I (intervention) C (comparison) O (outcome) model to locate all studies that investigated the clinical success of Tricalcium Silicate and Resin-based Tricalcium Silicate as indirect pulp-capping agents, compared to calcium hydroxide. Quality assessment was conducted for randomized and non-randomized clinical trials. Meta-analysis was performed using the random-effect model. A total of 561 articles were initially identified. Results: After removing duplicates, 393 unique titles remained. Nine full-text articles were assessed for eligibility, and six studies met the inclusion criteria for qualitative analysis, culminating in two Randomized Clinical Trials (RCTs) and four non‑RCTs. The meta-analysis encompassed three studies involving a total of 228 teeth, with 115 in the Biodentine group (experimental) and 113 in the Calcium hydroxide (Ca(OH)2) group (control). The findings revealed no significant difference in clinical and radiographic success at the 12-month follow-up. Conclusions: Current evidence suggests there is no statistically significant difference between tricalcium silicate-based materials (including resin-based formulations) and calcium hydroxide regarding clinical and radiographic outcomes when used for indirect pulp capping in primary molars. However, these findings should be interpreted with caution due to the limited number of studies and varying follow-up periods. The PROSPERO Registration: A protocol for this review was prepared and registered in the PROSPERO database (CRD42023482089) in November 2023.

Children; Indirect pulp capping; Liners; Primary molars; Vital pulp therapy

[1] Pitts NB, Twetman S, Fisher J, Marsh PD. Understanding dental caries as a non-communicable disease. British Dental Journal. 2021; 231: 749–753.

[2] Hilton TJ, Ferracane JL, Broome J. Summitt’s fundamentals of operative dentistry: a contemporary approach. 4th edn. Quintessence Publishing: Batavia, NY, USA. 2013.

[3] Maldupa I, Al-Yaseen W, Giese J, Ahmed Elagami R, Raggio DP. Recommended procedures for managing carious lesions in primary teeth with pulp involvement—a scoping review. BDJ Open. 2024; 10: 74.

[4] Mathur VP, Dhillon JK, Logani A, Kalra G. Evaluation of indirect pulp capping using three different materials: a randomized control trial using cone-beam computed tomography. Indian Journal of Dental Research. 2016; 27: 623–629.

[5] Shakti P, Singh A, Purohit BM, Purohit A, Taneja S. Effect of premature loss of primary teeth on prevalence of malocclusion in permanent dentition: a systematic review and meta-analysis. International Orthodontics. 2023; 21: 100816.

[6] Saber AM, El Meligy OA, Alaki SM. Recent advances in indirect pulp treatment materials for primary teeth: a literature review. International Journal of Clinical Pediatric Dentistry. 2021; 14: 795–801.

[7] Coll JA. Indirect pulp capping and primary teeth: is the primary tooth pulpotomy out of date? Journal of Endodontics. 2008; 34: S34–S39.

[8] Sousa GH, Gonçalves RL, Figueiredo B, Dias VCM, Mendes ACS, de Cássia Bueno Melo V, et al. Exploring vital pulp therapies: a bibliometric analysis of the most cited articles. The Saudi Dental Journal. 2024; 36: 778–788.

[9] Chaves HGDS, Figueiredo B, Maia CA, Reis-Prado AHD, Antunes MM, Mesquita RA, et al. Tissue response and expression of interleukins (IL)-1β, IL-6, IL-10 after pulp capping with bioglasses in mice. Brazilian Oral Research. 2024; 38: e096.

[10] Kunert M, Lukomska-Szymanska M. Bio-inductive materials in direct and indirect pulp capping—a review article. Materials. 2020; 13: 1204.

[11] Barry MJ, Baghlaf K, Alamoudi N. Silver diamine fluoride as a medicament for the indirect pulp therapy in primary teeth: a review of the literature. Cureus. 2024; 16: e60780.

[12] Shen Q, Sun J, Wu J, Liu C, Chen F. An in vitro investigation of the mechanical-chemical and biological properties of calcium phosphate/calcium silicate/bismutite cement for dental pulp capping. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2010; 94: 141–148.

[13] Shafi N, Kaur H, Choudhary R, Yeluri R. dilute silver diamine fluoride (1:10) versus light cure calcium hydroxide as indirect pulp capping agents in primary molars—a randomized clinical trial. Journal of Clinical Pediatric Dentistry. 2022; 46: 273–279.

[14] Lipski M, Nowicka A, Kot K, Postek-Stefańska L, Wysoczańska-Jankowicz I, Borkowski L, et al. Factors affecting the outcomes of direct pulp capping using Biodentine. Clinical Oral Investigations. 2018; 22: 2021–2029.

[15] Kayad M, Koura A, El-Nozahy A. A comparative histological study of the effect of TheraCal LC and biodentine on direct pulp capping in rabbits: an experimental study. Clinical oral investigations. 2023; 27: 1013–1022.

[16] Boddeda KR, Rani CR, V Vanga NR, Chandrabhatla SK. Comparative evaluation of biodentine, 2% chlorhexidine with RMGIC and calcium hydroxide as indirect pulp capping materials in primary molars: an in vivo study. Journal of the Indian Society of Pedodontics and Preventive Dentistry. 2019; 37: 60–66.

[17] Rajasekharan S, Martens LC, Cauwels RGEC, Anthonappa RP. BiodentineTM material characteristics and clinical applications: a 3 year literature review and update. European Archives of Paediatric Dentistry. 2018; 19: 1–22.

[18] Sahin N, Saygili S, Akcay M. Clinical, radiographic, and histological evaluation of three different pulp-capping materials in indirect pulp treatment of primary teeth: a randomized clinical trial. Clinical Oral Investigations. 2021; 25: 3945–3955.

[19] Christie B, Musri N, Djustiana N, Takarini V, Tuygunov N, Zakaria MN, et al. Advances and challenges in regenerative dentistry: a systematic review of calcium phosphate and silicate-based materials on human dental pulp stem cells. Materials Today Bio. 2023; 23: 100815.

[20] Moher D, Shamseer L, Clarke M, Ghersi D, Liberati A, Petticrew M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Systematic Reviews. 2015; 4: 1.

[21] Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration’s tool for assessing risk of bias in randomised trials. The BMJ. 2011; 343: d5928.

[22] Wells GA, Shea B, O’Connell D, Peterson J, Welch V, Losos M, et al. The Newcastle-Ottawa scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. 2021. Available at: https://www.ohri.ca/programs/clinical_epidemiology/oxford.asp (Accessed: 16 December 2024).

[23] Baghlaf K, Sindi AE, Almughalliq FA, Alarifi NK, Alquthami R, Alzahrani RA, et al. Effectiveness of silver diamine fluoride in indirect pulp capping in primary molars: a systematic review and meta-analysis. Heliyon. 2023; 9: e19462.

[24] Alharthy H, Elkhodary HM, Nahdreen A, Al Tuwirqi A, Baghlaf K. Comparative evaluation of retention and cariostatic effect of hydrophilic and hydrophobic resin-based sealants: a systematic review and meta-analysis. Nigerian Journal of Clinical Practice. 2022; 25: 861–884.

[25] Garrocho-Rangel A, Quintana-Guevara K, Vázquez-Viera R, Arvizu-Rivera JM, Flores-Reyes H, Escobar-García DM, et al. Bioactive tricalcium silicate-based dentin substitute as an indirect pulp capping material for primary teeth: a 12-month follow-up. Pediatric Dentistry. 2017; 39: 377–382.

[26] Chauhan A, Dua P, Saini S, Mangla R, Butail A, Ahluwalia S. In vivo outcomes of indirect pulp treatment in primary posterior teeth: 6 months’ follow-up. Contemporary Clinical Dentistry. 2018; 9: S69–S73.

[27] Gurcan AT, Seymen F. Clinical and radiographic evaluation of indirect pulp capping with three different materials: a 2-year follow-up study. European Journal of Paediatric Dentistry. 2019; 20: 105–110.

[28] Acharya S, Gurunathan D. Comparison of novel bioactive materials in indirect pulp therapy in deciduous teeth: an in vivo study. Brazilian Research in Pediatric Dentistry and Integrated Clinic. 2025; 25: e230202.

[29] Moselhy YH, Elghazawy RK, Wassel MO. Clinical and radiographic evaluation of indirect and direct pulp capping in primary molars using TheraCal (LC): a randomized clinical trial. Egyptian Dental Journal. 2022; 68: 3065–3076.

[30] Santos PSD, Pedrotti D, Braga MM, Rocha RO, Lenzi TL. Materials used for indirect pulp treatment in primary teeth: a mixed treatment comparisons meta-analysis. Brazilian Oral Research. 2017; 31: e101.

[31] Nair M, Gurunathan D. Clinical and radiographic outcomes of calcium hydroxide vs other agents in indirect pulp capping of primary teeth: a systematic review. International Journal of Clinical Pediatric Dentistry. 2019; 12: 437–444.

[32] Smaïl-Faugeron V, Glenny AM, Courson F, Durieux P, Muller-Bolla M, Fron Chabouis H. Pulp treatment for extensive decay in primary teeth. Cochrane Database of Systematic Reviews. 2018; 5: CD003220.

[33] Arora V, Nikhil V, Sharma N, Arora P. Bioactive dentin replacement. Journal of Dental and Medical Sciences. 2013; 12: 51–57.

[34] Arandi NZ, Rabi T. TheraCal LC: from biochemical and bioactive properties to clinical applications. International Journal of Dentistry. 2018; 2018: 3484653.

[35] Ozkaya CA, Armagan G, Akin D, Birim D, Mustafa A, Dagci T, et al. The comparative evaluation of cell viability, inflammatory response, and antimicrobial activity of calcium hydroxide-bovine dentin grain. Turkish Journal of Biochemistry. 2024; 49: 647–655.