Journal of Indian Society of Pedodontics and Preventive Dentistry
Journal of Indian Society of Pedodontics and Preventive Dentistry
                                                   Official journal of the Indian Society of Pedodontics and Preventive Dentistry                           
Year : 2022  |  Volume : 40  |  Issue : 2  |  Page : 105--111

Clinical Outcome of Direct Pulp Therapy in Primary Teeth: A Systematic Review and Meta-analysis

Parimala Kulkarni, Shilpi Tiwari, Nikita Agrawal, Anup Kumar, Poorva Umarekar, Sanjana Bhargava 
 Department of Pediatric and Preventive Dentistry, People's College of Dental Sciences and Research Centre, Bhopal, Madhya Pradesh, India

Correspondence Address:
Dr. Shilpi Tiwari
Department of Pediatric and Preventive Dentistry, Peoples College of Dental Sciences and Research Centre, Bhopal, Madhya Pradesh


Background: Direct pulp treatment is carried out when a healthy pulp gets mechanically/accidentally exposed during the operative procedures or trauma. Aim: To determine the effects of various direct pulp capping materials as measured by the clinical and radiographic analysis. Design: Two reviewers performed a database search of the studies published between January 2005 and November 2020. The inclusion criteria were papers published in the English language; children aged 3–12 years having deep carious lesions in primary teeth. All potential studies were acknowledged by their title and abstract. The full-text analysis of potentially relevant studies, the selected studies were included in the systematic review. A meta-analysis calculation was performed for the overall data and the subgroup data. Results: The database searching led to 57 articles, which were of direct pulp treatment in primary teeth, after the removal of duplicates, 55 records remained but did not meet all inclusion criteria. A high variability was observed among the papers. Further filtering with criteria led to nine articles, which met all inclusion criteria. Meta-analysis demonstrated the success rates of DPT in primary teeth (95% confidence interval −0.799–0.898); P < 0.001. Clinical assessments of various direct pulp capping materials suggested 84.9% of success irrespective of the material used. The nine studies were heterogeneous according to the random effect model (P < 0.001, I2 = 84.08%). Conclusions: Direct pulp treatment has the advantage of being a conservative vital pulp therapy reducing the need for a more invasive treatment.

How to cite this article:
Kulkarni P, Tiwari S, Agrawal N, Kumar A, Umarekar P, Bhargava S. Clinical Outcome of Direct Pulp Therapy in Primary Teeth: A Systematic Review and Meta-analysis.J Indian Soc Pedod Prev Dent 2022;40:105-111

How to cite this URL:
Kulkarni P, Tiwari S, Agrawal N, Kumar A, Umarekar P, Bhargava S. Clinical Outcome of Direct Pulp Therapy in Primary Teeth: A Systematic Review and Meta-analysis. J Indian Soc Pedod Prev Dent [serial online] 2022 [cited 2022 Aug 18 ];40:105-111
Available from:

Full Text


Despite recent advances in the prevention of dental caries and increased understanding of the significance of maintaining the natural dentition, many teeth are still prematurely lost. This loss can lead to malocclusion, phonetic, esthetic, or functional problems that may be transient or permanent in nature.

The aim of direct pulp treatment is to preserve pulp vitality by stimulating the young healthy pulp to form a reparative “dentin-like” bridge at the pulp exposed site.[1],[2] In direct pulp treatment, a bioactive restorative material is placed immediately on the exposed pulp to protect it from additional injury and to stimulate the regeneration potential of pulpal cells.[2],[3] Direct pulp treatment is a less invasive, economical, and relatively simple practice. The main biological difference between primary and permanent teeth is the higher content of undifferentiated mesenchymal stem cells in primary teeth,[4] which may differentiate to odontoclasts leading to internal resorption and failure of direct pulp treatment.[2],[3]

Modern pediatric dentistry looks for new strategies and materials to stimulate the regenerative capacity of dental tissues. Understanding of mechanisms that inhibit, control, and regulate internal resorption can assist in maintaining a primary tooth until normal exfoliation. This goal can be achieved by targeting undifferentiated mesenchymal cells leading to odontoblast differentiation and activation to regenerate a vital pulp by the formation of a continuous hard tissue barrier.[5] Simultaneously, bacterial contamination and inflammation, as the prime cause of treatment failure in primary teeth, should be reduced or eliminated. The objective of this review was to evaluate the long-term success of direct pulp treatment with various pulp capping materials in primary teeth.

 Materials and Methods

Eligibility criteria

This study was carried out in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analyses Statement.

The inclusion criteria were as follows: (1) Papers published in the English language, (2) Randomized controlled trials on direct pulp treatment in primary teeth, (3) children of age between 3 and 12 years, (4) Publication dates, sample sizes, and statistical analyses were not restricted in the screening of the articles.

The exclusion criteria were as follows: (1) nonhuman studies/in vitro studies, (2) studies with histological evaluation or only histological evaluation, (3) case-control and cohort studies, (4) indirect pulp capping/pulpotomy procedure, (5) unpublished manuscripts and thesis, book chapters, case studies, and other were excluded.

Literature search and search strategy

This systematic review was performed by thorough research of clinical studies that reported use of various direct pulp treatment materials in primary teeth.[6] The primary sources of the reviewed studies were MEDLINE, CENTRAL, EBSCO, and COCHRANE database. The search of literature published from 2005 to April 2020 in various databases with the English language was carried out [Table 1]. During the initial search, the following MeSH and keywords were employed: “direct pulp treatment” and (”primary OR deciduous” teeth), with the limitation of only human randomized clinical trials written in the English language. Combination strategies using Boolean Operator “OR” and “AND” were applied for searching the theme. Care was taken to use the combinations only once to avoid reptation and appearance of each article. In addition, the bibliographies of the final selected articles were hand-searched to identify any relevant publications that were not identified earlier. The authors of the included studies were contacted by E-mail for the identification of additional information.{Table 1}

Study selection

Two reviewers independently read all retrieved titles and abstracts. If one assessor regarded a publication as having met the inclusion criteria, the full text was obtained. Abstracts considered as potentially eligible, as well as those that did not supply enough information, were reserved for full-text assessment. Any differences concerning eligibility after evaluation of the full text were resolved over consensus, and when differences still persisted, a third reviewer was consulted before a final decision was reached.

Data extraction

Two reviewers independently conducted data extraction. General information such as authors, year of publication, and country was collected from each study. In addition, the following specific characteristics were also collected: (i) Direct pulp treatment in primary teeth, (ii) age range in years, (iii) sample size, (iv) interventions, (v) direct pulp treatment materials, and (ix) outcome.

Assessment of risk of bias

Quality assessment of the studies was performed to control the influence of bias. The four criteria were analyzed in all the included papers. The criteria items were as follows: (1) Eligibility criteria for the participants, (2) randomization, (3) sample size calculation, and (4) statistical analyses. Two of the reviewers assessed the included studies for risk of bias and were blinded to each other's assessments. Disagreements were resolved with a third reviewer. Domains from the Cochrane Collaboration risk of bias tool were assessed for each study. Data were entered into Review Manager Version 5.3 (Cochrane Collaboration, Copenhagen, Denmark) for graphical representation.


The outcome measure was based on the binary data of success/failure depending on dentin bridge formation/absence of dentin bridge formation. The nine studies were heterogeneous according to χ2 statistics and I2 (P < 0.001, I2 = 84.08%). Among the studies the heterogeneity was high, thus random effect model was used. A graphical informal test (Forest plot) [Figure 1] also confirmed the heterogeneity. Based on these data, the overall clinical and radiographic success of direct pulp therapy was statistically significant (95% confidence interval −0.799–0.898); P < 0.001). The success rate of direct pulp therapy was obtained by pooling the results of all nine studies and the pooled success rate was 84.9% irrespective of the material used for direct pulp therapy.{Figure 1}


Study selection

The database searching led to 57 articles, which were of direct pulp treatment in primary teeth, after removal of duplicates, 55 records remained but did not meet all inclusion criteria, further filtering with criteria led to 9 articles, which met all inclusion criteria [Figure 2].{Figure 2}

Design of included studies

The clinical randomized studies having control and experimental groups were included, where both groups received direct pulp treatment using various materials.

Study characteristics

All nine included studies were conducted in a university teaching hospital environment, out of these, four studies were conducted in Iran, four in Turkey and one in Mexico. The characteristics of the participants in included studies are presented in [Table 2].{Table 2}

Methodological quality assessment of included studies

The methodological quality of the relevant randomized controlled trials was assessed with the use of a scale developed and validated by Jadad et al.[7] The quantitative 5-point scale is based on randomization, blinding and reasons for withdrawal, where a score of 2 or more was considered to be high-impact randomized controlled trial. Based on the Jadad criteria, the quality scores were 4 for the studies by Garrocho-Rangel et al. (2009),[19] Tüzüner T. et al. (2012)[22], Erfanparast et al. (2018)[14], Vafaei et al. (2019)[28] and 3 for the study by Aminabadi et al. (2016)[21] and 2 for studies by Demir and Çehreli (2007)[26], Tuna and Ölmez (2008)[4], Aminabadi et al. (2010)[20], Ulusoy et al. (2014[27] [Table 2].


Dental pulp, is a vital tissue, possessing a number of important functions including dentin induction, formation, nutrition, defense, and sensation.[8] Therefore, ensuring dental pulp vitality is of great significance in maintaining the normal functions of the tooth. Both mechanical pulp exposure and caries exposure may bring irreversible damage to dental pulp if not treated properly. Direct pulp treatment is considered successful if the tooth remains vital and reparative dentin is formed within 75–90 days.[9] This therapy has shown considerable promise in maintaining pulpal vitality.

The primary goal of direct pulp treatment is to preserve tooth vitality. It is mandatory that no postoperative signs or symptoms exist such as sensitivity, pain, or swelling, under ideal circumstances the result should be both pulp healing and reparative dentin formation, and no pathologic evidence of external or internal root resorption or inter-radicular radiolucency should be observed radiographically.[10] According to the American Academy of Pediatric Dentistry recommendations and studies by Agamy et al., Maroto et al., Tuna and Olmez,[4],[11],[12] direct pulp treatment is indicated in the primary teeth with iatrogenic pulp exposure when biological circumstances are optimal and minimal exposure of pulp (one mm or less) occurs, and it is not recommended when the pulp exposure occurs during caries excavation of primary teeth, as in these cases nearly 100% of exposed pulps are already affected from the carious insult.[13]

In 2018, Erfanparast et al. evaluated direct pulp capping using a resin-modified Portland cement-based material (TheraCal) compared to MTA.[14] Based on clinical and radiographic criteria, the overall success rate for MTA and TheraCal was 94.5% and 91.8%, respectively in the 92 primary molars studied in 46 healthy children aged 5–7 years, at 6 and 12 months follow-up. The difference between the outcome of the two groups was not statistically significant (P > 0.05). The clinical and radiographic criteria considered to evaluate were pain, swelling, sinus tract, pathologic mobility, tenderness to palpation, sensitivity to percussion; and radiographic sign of internal and/or external root resorption, periodontal space widening, inter-radicular radiolucency, periapical lesions, and recurrent caries under the restoration.[14]

Songsiripradubboon et al. compared Dycal to Acemannan and concluded that Acemannan had higher success rates (based on clinical, radiographic, and histopathological evaluation).[15] The histopathological evaluation was based on pulp inflammation, dentine bridge formation, and soft-tissue organization. The biocompatibility and efficiency of Acemannan make it a decent biomaterial for short-term vital pulp therapy of deep active caries in primary teeth that have approximately half of the root length remaining.[15]

According to Coll et al., successful pulp capping is possible under defined conditions, such as disinfection of pulp exposures and isolation. The procedure seems to be successful, especially in Class-I cavities and tight sealing with ZnO + amalgam or adhesive in combination with stainless steel crown.[16] Fallahinejad et al. compared calcium-enriched mixture a novel biomaterial to calcium hydroxide and reported that calcium-enriched mixture is superior to calcium hydroxide, viz. It induces the formation of a complete hard tissue bridge thicker than that of calcium hydroxide and the presence of odontoblast cells beneath the hard tissue after direct pulp therapy. The favorable biocompatibility of calcium-enriched mixture and its ability to produce hydroxyapatite which is a natural component for dental pulp cells, which in turn induce a calcific response from the directly capped tissue, makes it a suitable biomaterial for direct pulp treatment.[17],[18]

In all nine relevant clinical trials, various bioactive materials such as calcium hydroxide, Enamel matrix derivative, MTA, 3Mixtatin, 3Mix, Simvastatin, and Formocresol, were used as direct pulp capping agents. The overall success rate (clinical and radiographic) was consistently better over a period of 2–24 months for enamel matrix derivative, MTA, 3Mixtatin, and Formocresol, with a success percentage of 97.7%, 93.8%, 91.9%, and 90%, respectively, as stated by Garrocho-Rangel et al., Tuna and Olmez, Aminabadi et al.[4],[19],[20],[21] Further Tüzüner et al. confirmed that the success rate of calcium hydroxide direct pulp therapy in primary molars could be enhanced by disinfecting the area of pulp exposure using antiseptic materials, namely 0.9% saline solution, 0.5% sodium hypochlorite, 2% chlorhexidine digluconate, and 1% octenidine dihydrochloride, he concluded that after 12 months follow-up 100% clinical and radiographic success was there with octenidine dihydrochloride direct pulp therapy.[22],[23],[24],[25] In addition, Demir and Cehreli evaluated the clinical and radiological response of primary molars, pulp-capped with calcium hydroxide and different adhesive systems (acetone-based total-etch adhesive [Prime and Bond NT]), nonrinse conditioner and Prime and Bond NT, total-etching with 36% phosphoric acid followed by Prime and Bond NT, self-etch adhesive system (Xeno III) after hemorrhage control with 1.25% sodium hypochlorite and reported approximately 93% overall success rate of direct pulp therapy.[26]

Ulusoy et al. evaluated the clinical and radiological response of direct pulp capping with calcium sulfate hemihydrate and calcium hydroxide and found 75% success with calcium sulfate hemihydrate at 12 months follow-up, the success rate did not differ significantly between calcium hydroxide and calcium sulfate hemihydrate treatment.[27] Further Vafaei et al. evaluated MTA and novel calcium silicate cement (Protooth) as direct pulp capping materials in primary teeth and reported 90% (37 out of 41 cases) and 85% (35 out of 41 cases) success, respectively, with no statistically significant differences after 6 and 12 months follow-up.[28] Data from the nine relevant studies reported lower radiographic success rates as compared to their clinical success, which lead to decrease in overall success outcome of the therapy. Although the studies stressed that radiographic results were important to evaluate the success or failure of DPT, only Aminabadi et al. and Tüzüner et al. reported statistically significant radiographic outcome (P < 0.05) in their studies. Thus, radiographic results may be considered vital for evaluating the success rates of direct pulp treatment and ongoing healing/necrosis.[20],[22]

Clinical considerations for better prognosis and successful results of direct pulp treatment in primary teeth are as follows: (1) Careful selection of cases based on a meticulous clinical and radiographic diagnosis,[19] (2) Adequate mechanical pulp exposure size[19] and disinfection of the exposed area using antiseptic solutions,[19] (3) Placement of direct pulp therapy material that preserves the pulp vitality and contributes to the active formation of new hard tissue by induction and upregulation of the differentiation of odontoblast cells,[19] and (4) Control of microleakage by the placement of the dentine adhesive, glass ionomer, and preformed metallic crown.[19]


All the studies in this meta-analysis demonstrated significant success rates of direct pulp treatment, with an overall success rate of 89.9%. Direct pulp treatment has the advantage of being a conservative vital pulp therapy reducing the need for a more invasive treatment. Close attention to rigid criteria for case selection along with the meticulous performance of the procedure, appear to be essential prerequisites for successful treatment outcome.[20] Therefore, direct pulp treatment should not be disregarded as a treatment option, especially in the primary teeth, although more studies (randomized controlled trials) may be imperative for substantiating the existing positive clinical evidence in favor of the above.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.


1Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am 2000;44:571-96, vii.
2Dammaschke T. The history of direct pulp capping. J Hist Dent 2008;56:9-23.
3Bodem O, Blumenshine S, Zeh D, Koch MJ. Direct pulp capping with mineral trioxide aggregate in a primary molar: A case report. Int J Paediatr Dent 2004;14:376-9.
4Tuna D, Olmez A. Clinical long-term evaluation of MTA as a direct pulp capping material in primary teeth. Int Endod J 2008;41:273-8.
5Vij R, Coll JA, Shelton P, Farooq NS. Caries control and other variables associated with success of primary molar vital pulp therapy. Pediatr Dent 2004;26:214-20.
6Chu Z, Ju B, Ni R. Clinical outcome of direct pulp capping with MTA or calcium hydroxide: A systematic review and meta-analysis. Int J Clin Exp Med 2015;8:17055-60.
7Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: Is blinding necessary? Control Clin Trials 1996;17:1-12.
8Swarup SJ, Rao A, Boaz K, Srikant N, Shenoy R. Pulpal response to nano hydroxyapatite, mineral trioxide aggregate and calcium hydroxide when used as a direct pulp capping agent: An in vivo study. J Clin Pediatr Dent 2014;38:201-6.
9Pameijer CH, Stanley HR. The disastrous effects of the “total etch” technique in vital pulp capping in primates. Am J Dent 1998;11:S45-54.
10Boutsiouki C, Frankenberger R, Krämer N. Relative effectiveness of direct and indirect pulp capping in the primary dentition. Eur Arch Paediatr Dent 2018;19:297-309.
11Agamy HA, Bakry NS, Mounir MM, Avery DR. Comparison of mineral trioxide aggregate and formocresol as pulp-capping agents in pulpotomized primary teeth. Pediatr Dent 2004;26:302-9.
12Maroto M, Barbería E, Vera V, García-Godoy F. Mineral trioxide aggregate as pulp dressing agent in pulpotomy treatment of primary molars: 42-month clinical study. Am J Dent 2007;20:283-6.
13Fuks AB. Vital pulp therapy with new materials for primary teeth: New directions and Treatment perspectives. Pediatr Dent 2008;30:211-9.
14Erfanparast L, Iranparvar P, Vafaei A. Direct pulp capping in primary molars using a resin-modified Portland cement-based material (TheraCal) compared to MTA with 12-month follow-up: A randomised clinical trial. Eur Arch Paediatr Dent 2018;19:197-203.
15Songsiripradubboon S, Banlunara W, Sangvanich P, Trairatvorakul C, Thunyakitpisal P. Clinical, radiographic, and histologic analysis of the effects of acemannan used in direct pulp capping of human primary teeth: Short-term outcomes. Odontology 2016;104:329-37.
16Coll JA, Seale NS, Vargas K, Marghalani AA, Al Shamali S, Graham L. Primary tooth vital pulp therapy: A systematic review and meta-analysis. Pediatr Dent 2017;39:16-123.
17Fallahinejad Ghajari M, Asgharian Jeddi T, Iri S, Asgary S. Direct pulp-capping with calcium enriched mixture in primary molar teeth: A randomized clinical trial. Iran Endod J 2010;5:27-30.
18Fallahinejad Ghajari M, Asgharian Jeddi T, Iri S, Asgary S. Treatment outcomes of primary molars direct pulp capping after 20 months: A randomized controlled trial. Iran Endod J 2013;8:149-52.
19Garrocho-Rangel A, Flores H, Silva-Herzog D, Hernandez-Sierra F, Mandeville P, Pozos-Guillen AJ. Efficacy of EMD versus calcium hydroxide in direct pulp capping of primary molars: A randomized controlled clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;107:733-8.
20Aminabadi NA, Farahani RM, Oskouei SG. Formocresol versus calcium hydroxide direct pulp capping of human primary molars: Two year follow-up. J Clin Pediatr Dent 2010;34:317-21.
21Asl Aminabadi N, Satrab S, Najafpour E, Samiei M, Jamali Z, Shirazi S. A randomized trial of direct pulp capping in primary molars using MTA compared to 3Mixtatin: A novel pulp capping biomaterial. Int J Paediatr Dent 2016;26:281-90.
22Tüzüner T, Alacam A, Altunbas DA, Gokdogan FG, Gundogdu E. Clinical and radiographic outcomes of direct pulp capping therapy in primary molar teeth following haemostasis with various antiseptics: A randomised controlled trial. Eur J Paediatr Dent 2012;13:289-92.
23Dogan AA, Adiloglu AK, Onal S, Cetin ES, Polat E, Uskun E, et al. Short-term relative antibacterial effect of octenidine dihydrochloride on the oral microflora in orthodontically treated patients. Int J Infect Dis 2008;12:e19-25.
24Tirali RE, Turan Y, Akal N, Karahan ZC. In vitro antimicrobial activity of several concentrations of NaOCl and Octenisept in elimination of endodontic pathogens. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2009;108:e117-20.
25Bal C, Alacam A, Tuzuner T, Tirali RE, Baris E. Effects of antiseptics on pulpal healing under calcium hydroxide pulp capping: A pilot study. Eur J Dent 2011;5:265-72.
26Demir T, Cehreli ZC. Clinical and radiographic evaluation of adhesive pulp capping in primary molars following hemostasis with 1.25% sodium hypochlorite: 2-year results. Am J Dent 2007;20:182-8.
27Ulusoy AT, Bayrak S, Bodrumlu EH. Clinical and radiological evaluation of calcium sulfate as direct pulp capping material in primary teeth. Eur J Paediatr Dent 2014;15:127-31.
28Vafaei A, Azima N, Erfanparast L, Løvschall H, Ranjkesh B. Direct pulp capping of primary molars using a novel fast-setting calcium silicate cement: A randomized clinical trial with 12-month follow-up. Biomater Investig Dent 2019;6:73-80.