Clinical and radiographic comparison of primary molar pulpotomy using formocresol, portland cement, and NeoMTA plus: a randomized controlled clinical trial
Pediatric dentistry aims to preserve primary teeth until natural exfoliation, safeguarding the dental arch, preventing permanent teeth malalignment, and ensuring their crucial roles in esthetics, speech, and mastication . Pulpotomy is considered a standard therapeutic approach for treating primary molars with inflamed and exposed pulps due to caries or traumatic injuries. Many researches have been aimed to increase the success rate of pulpotomy and also, various materials such as ferrous sulfate, calcium hydroxide, and aggregate mineral trioxide (MTA) have been developed for this purpose . The most frequently used pulp dressing material is formocresol (FC) (Buckley’s solution: formaldehyde, cresol, glycerol, and water) , which aims to disinfect and fix the underlying tissue . FC is recognized as the gold standard pulpotomy agent that all emerging modalities are judged against , . According to previous studies, despite the popularity of FC, it has been demonstrated side effects such as cytotoxicity, mutagenicity, and carcinogenicity , , .Moreover, other concerns about the use of FC include allergenicity, chromosomal damage to the dental pulp cells , chromosomal breaks, aberrations in peripheral lymphocytes , and mutagenesis of stem cells . Current trends in dentistry are focused on finding more biocompatible options to replace FC in primary teeth pulpotomies . Since 2001, in primary molars pulpotomy procedures, MTA has been used as an alternative to FC and has demonstrated clinical success rate similar to and even higher than FC . It was showed that MTA causes less inflammation, hyperemia, and necrosis, plus a thicker dentinal bridge than calcium hydroxide . However, despite the many advantages of MTA, such as the capacity of MTA to stimulate matrix formation and mineralization during dentinogenesis, it has some disadvantages, such as long setting time that leads to washout in presence of excess moisture, discoloration, mud-like consistency, leakage, solubility, low compressive strength due to its porous matrix, difficult handling, and high cost , . Recently, NeoMTA Plus has been introduced with the aim of improving the properties of MTA in pulpotomy. It has exceptionally high cell migration rates and appropriate cytocompatibility with human dental pulp cells . Tantalum oxide in NeoMTA Plus increases the production of mineralized nodules, which is very important in endodontic treatment processes . Also, Tantalum oxide improves NeoMTA Plus observation on radiographs . NeoMTA Plus enhances the healing rate because it generates calcium hydroxide, which elevates the pH to 12.5 , . NeoMTA Plus has calcium phosphate forming capacity, which could improve its bioactivity and biocompatibility for its use for vital pulp therapies . It has shown that NeoMTA Plus is not cytotoxic or genotoxic , and has antimicrobial effect , and dentin bridge formation properties , . Portland cement has gained attention in dental research due to its similarity to MTA, a widely used biocompatible material . It is obtained by calcination limestone with argillaceous silicon , . Once the product was calcined and finely ground, it displayed binder properties when combined with water to create a mortar that was stable, easy to handle, and had binder capacity . It has been shown that PC is biocompatible and can lead to neoformation of the extracellular matrix .The favorable characteristics of PC including antibacterial activity, biocompatibility, bioinductivity and acceptable setting time .Compared to MTA, PC does not differ much in physical properties, cytotoxicity, and genotoxicity , . But there is no study to compare the NeoMTA Plus and PC. In addition, there are limited clinical trials on PC. Therefore, PC is now under investigation of comprehensive properties promoting its usage in clinical dentistry as an alternative to MTA and FC . According to Tewari et al., there is a lack of evidence regarding the choice of pulpotomy medicaments for treating caries-affected primary teeth . Recent systematic reviews and meta-analyses, however, have failed to establish the superiority of pulpotomy techniques and materials , . No published study has compared the therapeutic success rates of PC and NeoMTA Plus with FC as pulpotomy agents. Therefore, the primary objective of the present study was to determine the clinical and radiographic success rate of FC, PC, and NeoMTA Plus as pulpotomy agents in primary molars and their success rates after 6 and 12 months. The second objective was to evaluate the effect of age, sex, jaw, and type of primary molars on the success rate of the treatment. The null hypothesis was that FC, PC, and NeoMTA Plus would show no significant difference in clinical and radiographic success rate. 

Statistical population and study design The statistical population of this randomized, controlled, double-blind clinical trial consisted of systemically healthy children 3–9 years of age, needing pulpotomy in one primary molar referring to a pediatric dental office in Kerman (Iran). In accordance with clinical criteria in this study, the standard diagnosis of asymptomatic irreversible pulpitis with normal apical tissues in primary molars was used . This clinical trial was conducted in accordance with the Helsinki Declaration of Human Rights. Also, this research approved by the Kerman University of Medical Sciences Ethics Committee, Kerman Province, Kerman, Iran, under the code IR.KMU.REC.1400.223. Participants were recruited in a pediatric dental office located in Kerman Province between March 2022 and August 2023 under the supervision of the IRCT organization 14/03/2022 with the ID No IRCT20180521039763N5 on ClinicalTrials.gov. The study design followed the 2010 CONSORT Statement: Updated guidelines for reporting parallel group randomized trials . Based on the formula below, the sample size (n) required to detect a 30% difference in success rate at a significance level of α = 0.05 (two-sided), power = 0.80, p 1 = 73.3%, p 2 = 100%, Z1-α/2 = 1.96, Z1-β = 0.84 was calculated at n = 32 in each group and 96 in total in three groups . [12pt]{minimal}
				
				 
				 
				 
				
				
				
				
				$$n =  + z( ) {_{1} (1 - _{1} ) + _{2} (1 - _{2} )} } ]^{2} }}{{^{2} }}$$ Ninety-six primary molar teeth that met the inclusion criteria were randomly assigned to one of the three groups of FC, PC, and NeoMTA Plus. This study allocated subjects to three groups through a random number table and block randomization method. The generated random number sequence was also blinded and produced independently by a statistician. A dental hygienist opened an opaque, sealed, and serially numbered envelope to reveal the treatment allocation. The study’s objectives and the implementation method were elucidated to the parents or legal guardian, and written informed consent was acquired. Inclusion criteria Good general health (ASA 1), free from any systemic disease, as classified by the American Society of Anesthesiologists (ASA Class); healthy periodontal and gingiva tissues; and children who score positive or definitely positive on the Frankle behavioral rating scale. There were no abnormalities or hypoplastic anomalies in any of the teeth. The clinical criteria for asymptomatic irreversible pulpitis and normal apical tissues were a vital tooth with carious pulp exposure without lingering thermal pain, spontaneous pain, or referred pain, no pathological tooth mobility, no pain on percussion or palpation, no fistula, abscess, or swelling, the possibility of restoring the tooth with a stainless-steel crown(SSC), and controllable pulp bleeding . Radiographic criteria for tooth selection included caries involving the inner third of dentin or approaching the pulp, no internal or external pathological root resorption, no radiolucency at the apex and furcal region, and no evidence of periodontal ligament widening. The periapical radiographs were taken using the parallel technique and with Rinn XCP (Dentsply, Sirona, York, Pa., USA) to increase reproducibility. A lead apron and a thyroid collar were also used to reduce patient exposure. Exclusion criteria Participants with allergies to local anesthetics, teeth that was difficult to isolate by the rubber dam, and teeth with physiological resorption involving more than two-thirds of the root length and also, parents who declined to let their children to take part in the trial were excluded from the study. Any radiographic signs such as internal resorption, external resorption, periodontal ligament widening, radiolucency around the apex or furcal area, and obliteration of the pulp canals were not considered for inclusion. Clinical procedures The treatment was performed by an experienced pedodontist in the pediatric dental office using FC (Sultan, New Jersey, USA), PC (Votoran, São Paulo, Brazil), or NeoMTA Plus (Avalon Biomed, Houston, USA). Topical anesthetic (20 percent benzocaine; Ultracare, Ultradent products, Inc., South Jordan, Utah, USA) is applied to the mucosa after a gauze pad has been used to dry the area. The carious primary first and second molars underwent a local anesthetic procedure using local infiltration and posterior superior alveolar nerve block technique in the maxilla respectively. The carious primary first and second molars were anesthetized using inferior alveolar nerve block (IANB) in the mandible and isolated with a rubber dam. The local anesthesia was 2% lidocaine with 1:80,000 epinephrine (Persocaine, Daroopakhsh Company, Tehran, Iran). Carious enamel was removed using a sterile high-speed diamond bur, and carious dentin was removed with a sterile low-speed round carbide bur. The exposed superficial pulp was gently removed with a sterile round bur (Drendel and Zweiling Diamant GmbH, Lemgo, Germany) in a high-speed handpiece under low-pressure cold-water irrigation until the orifices stump are clearly visible without any tags remaining. A sterile wet cotton pellet was placed on the area with mild pressure to control bleeding for 5 min. Hemostasis was achieved in all the cases successfully. After achieving hemostasis, in the FC group, a cotton pellet impregnated with FC with a 1:5 concentration (20% FC diluted with Buckley Solution, Sultan, New Jersey, USA) was placed on the root canal orifices for 5 min. The material was prepared using the manufacturer’s instructions in the NeoMTA Plus (Avalon Biomed, Houston, USA) group. An amalgam carrier was used to place the material. The NeoMTA Plus mix at root canal orifices was gently packed with a wet cotton pellet. A 2–3-mm-thick NeoMTA Plus layer covered the root canal orifices. In the PC (Votoran, São Paulo, Brazil) group, the cement was sterilized with ethylene oxide gas before it was applied; 0.2 g of cement was mixed with distilled water to achieve a homogeneous mix which was placed in the pulp chamber floor and smoothened and packed with a slightly wet cotton pellet. Subsequently, in the FC group, zinc oxide eugenol paste (Kemdent, Associated Dental Products Ltd., Swindon, UK) was used as a dressing, followed by zinc phosphate paste (Hanse Dental GmbH, Oldenburg, Germany) in the pulp chamber. In PC and NeoMTA Plus groups, zinc oxide eugenol was used and the cavity was filled with glass ionomer cement (GC Fuji II, Tokyo, Japan). Finally, a SSC was placed as a final restoration (3M Unitek, St. Paul, Minn., USA) using glass-ionomer cement (GC Fuji I, Tokyo, Japan) in all groups. During the same visit, the pulpotomy procedure and the SSC placement were performed. All research steps were carried out using behavioral guidance techniques without any drugs. Study outcomes The clinical success criteria of the teeth were as follows: no pain; not be sensitive to percussion; absence of any pathological mobility; no sign of abscess or swelling; no fistula or sinus tract; achieving hemostasis five minutes following the coronal pulp amputation. The radiographic success criteria included the following: no pathological internal root resorption or external resorption; absence of any radiolucency at the furcation or periapex; absence of PDL widening. The pulp canal obliteration (PCO) was also checked in the radiographic examinations, and this complication was considered a success. Any tooth with failure treatment underwent appropriate treatment (e.g., total pulpectomy or extraction and place a space maintainer if necessary). Outcome evaluation After six and twelve months, the patients were recalled to evaluate the outcomes clinically and radiographically. Clinical and radiographic failure was defined as the observation of any clinical and radiographic outcomes mentioned previously at the end of follow up periods. After calibration, radiographic evaluation, clinical evaluation, and recruitment criteria evaluations were carried out by another two independent pedodontits who were unaware of the treatment type. The observers evaluated 10% of the radiographs. Cohen’s kappa coefficient was used to measure intra- and inter-examiner reliability. The kappa coefficient was 0.90 for two months’ inter-examiner reliability (perfect agreement). The kappa coefficient was 0.88 for intra-examiner reliability (perfect agreement). If there was disagreement between the two observers, a consensus was reached after discussion and re-evaluation of the case. To assess the clinical outcomes, participants underwent an examination using disposable dental mirror and explorer. The radiographic images were interpreted on a 20-inch LED computer monitor (HP W2082a, Palo Alto, Calif., USA). The information obtained in each group was recorded in a separate form. The crowns of the primary molars were covered to hide the material used in the coronal part of the tooth to blind the examiners when evaluating the radiographic failures. The participants, parents and statistician were also blinded to the treatment method and the materials used in the research. Data collection and statistical analysis Total failure refers to any tooth with clinical or radiographic failure. Each treatment modality’s clinical success rate, radiography, and overall success rate were calculated at the six and 12-month follow-up sessions. The variables age, gender, second/first molar, maxilla/mandible were collected by a checklist. The data were analyzed according to group assignment (intention-to-treat). SPSS 26 (SPSS Inc., Chicago, Ill., USA) was used for data analysis, and ANOVA, chi-squared test, and Fisher’s exact test were used for data analyses. The significance level was defined at P < 0.05. Ethics approval and consent to participate The study’s objectives and the implementation method were explained to the parents, and informed consent was obtained. Participants were assured that their information would remain confidential. This clinical trial was conducted in accordance with the Helsinki Declaration of Human Rights. Also, this research approved by the Kerman University of Medical Sciences Ethics Committee, Kerman Province, Kerman, Iran, under the code IR.KMU.REC.1400.223. This study was under the supervision of the IRCT organization 14/03/2022 with the ID No IRCT20180521039763N5 on ClinicalTrials.gov. Participants could also withdraw from the study at any time. The authors have no conflicts of interest to declare relevant to this article. 

The statistical population of this randomized, controlled, double-blind clinical trial consisted of systemically healthy children 3–9 years of age, needing pulpotomy in one primary molar referring to a pediatric dental office in Kerman (Iran). In accordance with clinical criteria in this study, the standard diagnosis of asymptomatic irreversible pulpitis with normal apical tissues in primary molars was used . This clinical trial was conducted in accordance with the Helsinki Declaration of Human Rights. Also, this research approved by the Kerman University of Medical Sciences Ethics Committee, Kerman Province, Kerman, Iran, under the code IR.KMU.REC.1400.223. Participants were recruited in a pediatric dental office located in Kerman Province between March 2022 and August 2023 under the supervision of the IRCT organization 14/03/2022 with the ID No IRCT20180521039763N5 on ClinicalTrials.gov. The study design followed the 2010 CONSORT Statement: Updated guidelines for reporting parallel group randomized trials . Based on the formula below, the sample size (n) required to detect a 30% difference in success rate at a significance level of α = 0.05 (two-sided), power = 0.80, p 1 = 73.3%, p 2 = 100%, Z1-α/2 = 1.96, Z1-β = 0.84 was calculated at n = 32 in each group and 96 in total in three groups . [12pt]{minimal}
				
				 
				 
				 
				
				
				
				
				$$n =  + z( ) {_{1} (1 - _{1} ) + _{2} (1 - _{2} )} } ]^{2} }}{{^{2} }}$$ Ninety-six primary molar teeth that met the inclusion criteria were randomly assigned to one of the three groups of FC, PC, and NeoMTA Plus. This study allocated subjects to three groups through a random number table and block randomization method. The generated random number sequence was also blinded and produced independently by a statistician. A dental hygienist opened an opaque, sealed, and serially numbered envelope to reveal the treatment allocation. The study’s objectives and the implementation method were elucidated to the parents or legal guardian, and written informed consent was acquired. 

Good general health (ASA 1), free from any systemic disease, as classified by the American Society of Anesthesiologists (ASA Class); healthy periodontal and gingiva tissues; and children who score positive or definitely positive on the Frankle behavioral rating scale. There were no abnormalities or hypoplastic anomalies in any of the teeth. The clinical criteria for asymptomatic irreversible pulpitis and normal apical tissues were a vital tooth with carious pulp exposure without lingering thermal pain, spontaneous pain, or referred pain, no pathological tooth mobility, no pain on percussion or palpation, no fistula, abscess, or swelling, the possibility of restoring the tooth with a stainless-steel crown(SSC), and controllable pulp bleeding . Radiographic criteria for tooth selection included caries involving the inner third of dentin or approaching the pulp, no internal or external pathological root resorption, no radiolucency at the apex and furcal region, and no evidence of periodontal ligament widening. The periapical radiographs were taken using the parallel technique and with Rinn XCP (Dentsply, Sirona, York, Pa., USA) to increase reproducibility. A lead apron and a thyroid collar were also used to reduce patient exposure. 

Participants with allergies to local anesthetics, teeth that was difficult to isolate by the rubber dam, and teeth with physiological resorption involving more than two-thirds of the root length and also, parents who declined to let their children to take part in the trial were excluded from the study. Any radiographic signs such as internal resorption, external resorption, periodontal ligament widening, radiolucency around the apex or furcal area, and obliteration of the pulp canals were not considered for inclusion. 

The treatment was performed by an experienced pedodontist in the pediatric dental office using FC (Sultan, New Jersey, USA), PC (Votoran, São Paulo, Brazil), or NeoMTA Plus (Avalon Biomed, Houston, USA). Topical anesthetic (20 percent benzocaine; Ultracare, Ultradent products, Inc., South Jordan, Utah, USA) is applied to the mucosa after a gauze pad has been used to dry the area. The carious primary first and second molars underwent a local anesthetic procedure using local infiltration and posterior superior alveolar nerve block technique in the maxilla respectively. The carious primary first and second molars were anesthetized using inferior alveolar nerve block (IANB) in the mandible and isolated with a rubber dam. The local anesthesia was 2% lidocaine with 1:80,000 epinephrine (Persocaine, Daroopakhsh Company, Tehran, Iran). Carious enamel was removed using a sterile high-speed diamond bur, and carious dentin was removed with a sterile low-speed round carbide bur. The exposed superficial pulp was gently removed with a sterile round bur (Drendel and Zweiling Diamant GmbH, Lemgo, Germany) in a high-speed handpiece under low-pressure cold-water irrigation until the orifices stump are clearly visible without any tags remaining. A sterile wet cotton pellet was placed on the area with mild pressure to control bleeding for 5 min. Hemostasis was achieved in all the cases successfully. After achieving hemostasis, in the FC group, a cotton pellet impregnated with FC with a 1:5 concentration (20% FC diluted with Buckley Solution, Sultan, New Jersey, USA) was placed on the root canal orifices for 5 min. The material was prepared using the manufacturer’s instructions in the NeoMTA Plus (Avalon Biomed, Houston, USA) group. An amalgam carrier was used to place the material. The NeoMTA Plus mix at root canal orifices was gently packed with a wet cotton pellet. A 2–3-mm-thick NeoMTA Plus layer covered the root canal orifices. In the PC (Votoran, São Paulo, Brazil) group, the cement was sterilized with ethylene oxide gas before it was applied; 0.2 g of cement was mixed with distilled water to achieve a homogeneous mix which was placed in the pulp chamber floor and smoothened and packed with a slightly wet cotton pellet. Subsequently, in the FC group, zinc oxide eugenol paste (Kemdent, Associated Dental Products Ltd., Swindon, UK) was used as a dressing, followed by zinc phosphate paste (Hanse Dental GmbH, Oldenburg, Germany) in the pulp chamber. In PC and NeoMTA Plus groups, zinc oxide eugenol was used and the cavity was filled with glass ionomer cement (GC Fuji II, Tokyo, Japan). Finally, a SSC was placed as a final restoration (3M Unitek, St. Paul, Minn., USA) using glass-ionomer cement (GC Fuji I, Tokyo, Japan) in all groups. During the same visit, the pulpotomy procedure and the SSC placement were performed. All research steps were carried out using behavioral guidance techniques without any drugs. 

The clinical success criteria of the teeth were as follows: no pain; not be sensitive to percussion; absence of any pathological mobility; no sign of abscess or swelling; no fistula or sinus tract; achieving hemostasis five minutes following the coronal pulp amputation. The radiographic success criteria included the following: no pathological internal root resorption or external resorption; absence of any radiolucency at the furcation or periapex; absence of PDL widening. The pulp canal obliteration (PCO) was also checked in the radiographic examinations, and this complication was considered a success. Any tooth with failure treatment underwent appropriate treatment (e.g., total pulpectomy or extraction and place a space maintainer if necessary). 

After six and twelve months, the patients were recalled to evaluate the outcomes clinically and radiographically. Clinical and radiographic failure was defined as the observation of any clinical and radiographic outcomes mentioned previously at the end of follow up periods. After calibration, radiographic evaluation, clinical evaluation, and recruitment criteria evaluations were carried out by another two independent pedodontits who were unaware of the treatment type. The observers evaluated 10% of the radiographs. Cohen’s kappa coefficient was used to measure intra- and inter-examiner reliability. The kappa coefficient was 0.90 for two months’ inter-examiner reliability (perfect agreement). The kappa coefficient was 0.88 for intra-examiner reliability (perfect agreement). If there was disagreement between the two observers, a consensus was reached after discussion and re-evaluation of the case. To assess the clinical outcomes, participants underwent an examination using disposable dental mirror and explorer. The radiographic images were interpreted on a 20-inch LED computer monitor (HP W2082a, Palo Alto, Calif., USA). The information obtained in each group was recorded in a separate form. The crowns of the primary molars were covered to hide the material used in the coronal part of the tooth to blind the examiners when evaluating the radiographic failures. The participants, parents and statistician were also blinded to the treatment method and the materials used in the research. 

Total failure refers to any tooth with clinical or radiographic failure. Each treatment modality’s clinical success rate, radiography, and overall success rate were calculated at the six and 12-month follow-up sessions. The variables age, gender, second/first molar, maxilla/mandible were collected by a checklist. The data were analyzed according to group assignment (intention-to-treat). SPSS 26 (SPSS Inc., Chicago, Ill., USA) was used for data analysis, and ANOVA, chi-squared test, and Fisher’s exact test were used for data analyses. The significance level was defined at P < 0.05. 

The study’s objectives and the implementation method were explained to the parents, and informed consent was obtained. Participants were assured that their information would remain confidential. This clinical trial was conducted in accordance with the Helsinki Declaration of Human Rights. Also, this research approved by the Kerman University of Medical Sciences Ethics Committee, Kerman Province, Kerman, Iran, under the code IR.KMU.REC.1400.223. This study was under the supervision of the IRCT organization 14/03/2022 with the ID No IRCT20180521039763N5 on ClinicalTrials.gov. Participants could also withdraw from the study at any time. The authors have no conflicts of interest to declare relevant to this article. 

Ninety-six primary molars in 49 girls and 47 boys were treated in this study. The mean age of these participants was 5.5 ± 1.41 years. Two patients dropped out of the study after six months, and three additional patients dropped out after 12 months. The final sample size was 91 patients (Fig. ). The integrity of the restorations (SSC) was evaluated during the 6- and 12-month follow-up periods. None of them had any problems in terms of integrity. One case of external root resorption was detected in the FC group, and two cases of internal resorption were seen in the PC group, with no cases in the NeoMTA Plus group. These differences were not statistically significant ( P = 0.993). One case of furcal radiolucency was observed in the FC group, and one case was observed in the NeoMTA Plus group, with no cases in the PC group; these differences were not statistically significant ( P = 0.989). Eleven (34.4%) pulp canal obliteration (PCO) cases were observed in the FC group, with nine (28.1%) in the PC group and eight (25.0%) in the NeoMTA Plus group, with no significant difference ( P = 0.992). The variables of gender and age did not have a significant difference between the treatment groups ( P = 0.750, P = 0.321). Also, there were no significant differences regarding tooth type and jaw between FC, PC, and NeoMTA Plus groups ( P = 0.855, P = 0.112) (Table ). At baseline, the frequency of proximal and occlusal caries showed no significant difference between the two groups ( P = 0.736). Regarding clinical symptoms, no symptoms, including pain, tenderness, tooth mobility, abscess, and fistula, were observed after the follow-up period in the three treatment groups at six- and 12-month follow-ups. The radiographic and overall clinical success rate was not significantly different at six- and 12-month follow-up ( P = 0.999) (Table ), (Fig. ). The association between overall outcome, and gender ( P = 0.667), type of jaw ( P = 1), and tooth type ( P = 0.348) was not significantly different. 

The null hypothesis was confirmed in the present study, and no significant difference was seen between FC, PC, and NeoMTA Plus regarding clinical and radiographic success rate. Based on the results, the clinical success rate of FC, PC, and NeoMTA Plus was the same (100%) and the radiographic success rates were 93.8, 93.8, and 96.9% at 12-month follow up respectively. There is no published study regarding clinical and radiographic comparison of primary molars’ pulpotomy using FC, PC and NeoMTA Plus. The strength of this study was the low number of cases lost to follow up. Also, the first and second primary molars were studied in each jaw to investigate the effect of three materials on the primary molars with different pulp shapes and neurovascular and nutritional sources. In this study, SSCs were selected for the final restoration due to their biological seal, which is crucial to their success , . Their primary advantages include enhanced durability, extended longevity, and a low incidence of recurrent caries . Additionally, SSCs are preferred for restorations in posterior regions because their properties most closely resemble the functional behavior of natural teeth . The final restoration quality plays a significant role in the treatment outcome . Some studies suggest that coronal sealing may be more important than biocompatibility material in vital pulp therapy . The high success rates in the present study can be attributed to the high quality of coronal sealing. Strict adherence to teeth in which the pulp state was adequate for pulpotomy is another advantage of this study. In this study, the 12-month success rate was consistently high across all three groups with no significant difference. In comparing FC and PC, Petel et al. reported that the overall success rate of pulpotomy treatments performed with FC in the follow-up period of 2–4 years was 91.1, and the success rate of treatments performed with pure PC was 100%. The results showed no special advantage for these two materials, and PC could be used as an alternative to FC, consistent with the present study . In a 2-year follow-up by Yildirim et al. on FC, PC, MTA, and enamel matrix in pulpotomy treatment of primary molars, the clinical success rates of FC and PC were 96.9 and 93.9%, respectively. The radiographic success rates of FC and PC were 84.4 and 86.7%, respectively. These findings did not show a significant difference between these two materials from a clinical and statistical point of view . The lower success rate of Yildirim et al. study may be related to longer follow up period. Alsanouni and Bawazir compared the clinical and radiographic success rate of NeoMTA Plus and ProRoot MTA. The clinical success rate of ProRoot MTA and NeoMTA Plus were 97.4, and 100% respectively. The radiographic success rate of ProRoot MTA and NeoMTA Plus were 94.9 and 97.5% respectively, which is consistent with the finding of this study . In the systematic review conducted by Jayaraman et al., the 12-month radiographic and clinical success rate of FC were reported as 95% and 98.8%, respectively, which is in line with the results of the present study . In another systematic review conducted by Meslmani et al., the 12-month radiographic and clinical success rate of PC were estimated as 93.3 and 93.3%, respectively, which is similar to the results of the present study . There are many studies that compered MTA, FC and PC pairewisely, , but there is no study has compered FC, PC and NeoMTA Plus. In the present study, there was no significant relationship between the gender, type of teeth and clinical and radiographic success rates. In a meta-analysis by Shirvani et al., no significant relationship was observed between the tooth type, age, and gender of the participants and the success rate of the treatment , which is consistent with the results of the present study. In this study, after a 12-month period, one case of furcal radiolucency and one case of external root resorption was reported in the FC group and, two cases of internal resorption in the PC group. Moreover, one case of furcal radiolucency was seen in NeoMTA Plus group. The observed failures could have occurred for various reasons. Even after coronal pulp tissue is amputated, furcal radiolucency may be observed as a result of the presence of micropulp remnants; the frequency of these changes may depend on the concentration of the medicament and the duration of FC application . Additionally, it could be due to the smaller molecular size of FC allowing diffuse into the apical area of primary molars via the pulpal canal(s) or into the furcation through accessory canals or the pulpal floor, as it is thin, porous and permeable in nature . It is well known that the exact mechanism underlying the use of FC to induce external root resorption remains unclear. One possibility is that FC irritation causes a cell-mediated reaction to normal tissue, which in turn increases the rate of external root resorption . Odontoclastic activity has been observed to cause internal resorption, which indicates that an affected tooth is maintaining some degree of vitality and function over time. There is an assumption that the predisposing factor of internal resorption causes vascular changes in the pulp, which leads to the formation of granulation tissue and inflammation. Internal resorption following the pulpotomy procedure is thought to be caused by the medicaments’ irritating effects . The failures observed in the treated cases in the present study may be due to the failure of SSC which is rare . Another reason for failure can be improper treatment procedure. Since the treatment procedure in this study was performed by an experienced pedodontist, the possibility of error in the treatment procedure was low. Also, the observed failures may be related to the material used to cover the pulp. Therefore, it is very difficult to determine the main cause of failures in each group. In the present study, the number of PCOs reported in the three groups of FC, PC, and NeoMTA Plus was 8 (25%), 9 (28.1%), and 11 (34.4%), respectively, with no significant difference between the number of reported PCOs. In this study PCO was not considered a failure. Regarding PCO, there are generally several schools of thought. While some authors consider it as a failure due to its difference from normal pulp , ,others did not consider it as a failure because odontoblastic activity was present. It may indicate that a tooth was maintaining some level of vitality and function over time , . The observed PCOs rates in our study were in the range of other published studies. Alsanouni and Bawazir reported the PCOs rate in NeoMTA Plus was 50% at 12-month follow up period . PCO was detected in a wide range (0–52%) of teeth treated by FC pulpotomy – . Sakai et al. observed the PCOs rate in PC group was 100% at 24-month follow-up . It was showed that NeoMTA Plus has easy handling, decreased setting time, increased ion release, increased water sorption and non-staining radiopacifiers . Additionally, it exhibits the production of calcium hydroxide necessary to cause the formation of mineralized tissue . It is marketed as a new stain-free tricalcium silicate material . The beneficial properties of PC including antibacterial activity , biocompatibility , bio inductivity , non-cytotoxicity , good seal ability, acceptable setting time, and physical and mechanical characteristics are the rationale behind its widespread applications including the repair of root perforation and resorption, pulpotomy, and vital pulp therapy . PC also has good mechanical properties; its initial setting time is about 43 min, and the final setting time is about 177 min , which means it takes shorter time to deliver treatment with this material than with NeoMTA Plus(setting time:315 min) . FC acts only as a dressing material and needs a restorative agent to seal the pulp chamber. For this reason, the treatment time of pulpotomy with FC is longer. In addition, there is a possibility that the cotton fibers will stick to the clot during the removal of the cotton pellets impregnated with FC, which can lead to bleeding , while there is no such problem with NeoMTA Plus and PC. Therefore, NeoMTA Plus can be regarded as the ideal pulpotomy substance for primary molars. In this study, NeoMTA Plus is shown to have superior clinical and radiographic success rates, along with unique benefits such as absence of dental tissue discoloration , and higher antimicrobial properties . Nevertheless, some practitioners may still prefer PC for its unique advantages. PC provided higher mechanical properties, including surface microhardness and compressive strength . Additionally, its lower cost makes it an attractive option for budget-conscious practices or in situations where cost-effectiveness is a priority. The choice of material ultimately be influenced by the specific clinical requirements, patient needs, and practitioner preferences. Balancing these factors is crucial in determining the most suitable material for each case, ensuring optimal treatment outcomes while considering practical and economic aspects of dental practice. In the FC group, zinc phosphate cement served as the intermediate material, while GIC was utilized in the other two groups; nevertheless, the final restoration for all three groups was identical, performed with SSC. However, no significant difference was observed between the study groups. As a result, the use of intermediate materials and the final restoration did not influence the success rate. In general, to evaluate the success rate of the pulpotomy medicaments, it is better to assess the outcomes for long periods. One of the limitations of the present study was that only 12 months of follow-up assessment. In the future, it is suggested that studies with more extended follow-up periods and larger sample size are conducted. Furthermore, the angle of the periapical radiograph may significantly impact the assessment of caries proximity to the pulp in borderline cases. Therefore, the use of bitewing radiographs could aid in the diagnosis of teeth with decay and exposed pulp. It is essential to examine the success rate of the treatment modalities histologically, because it shows the minor effects of the materials used on the pulp tissue. 

Considering the limitations of the present study, the following conclusions can be made: The comparison of FC, PC, and NeoMTA Plus in the pulpotomy of primary molars showed that the overall success rates of these three substances were similar. PC and NeoMTA Plus can be suggested as alternatives to FC in future pulpotomy treatments. The effect of age, sex, jaw and type of primary molars on the success rate of the treatment was not significant. 

