Pulpotomies in Primary Molars

This is a retrospective review of thirty-month outcomes of Biodentine Pulpotomies in Primary Molars by Wong et al in 2020. This review was presented by Brisbane Kids Dentists.

A pulpotomy procedure is typically performed when caries removal results in a carious or mechanical pulp exposure in a primary tooth without evidence of radicular pathology.

The inflamed coronal pulp is removed and the remaining radicular pulp stump is treated with a medicament, allowing for final tooth restoration and retention of the primary tooth.

vital pulp therapy→ carious primary tooth→ reversible pulpitis 

inflamed coronal pulp removed→radicular pulp stump treated with medication

The ideal properties of pulpotomy medicaments are listed below from a systematic review by Coll et al. in 2017:

• non-toxic
• non-mutagenic
• non-carcinogenic
• biocompatible
• dimensionally stable
• bactericidal
• harmless to the pulp & surrounding structures
• promote healing of radicular pulp
• not interfering with the physiological process of root resorption

majority of primary molars successful over 30 month study period

primary first molar=primary second molar

maxillary=mandibular 

• 9 clinical failures 
  • first-year: 5  failures
  • 3 loss of full coverage 
  • 2 pain/soft tissue pathology 
• second-year →1 tooth with pain and pathological mobility
• the third year →3 more teeth with pain

• The majority of primary molars were clinically successful
• over the 30-month study period.
• There were no observable differences in clinical outcomes when comparing both
• primary first and second molars or when comparing maxillary to mandibular teeth. 
• There was a total of nine clinical failures over the 30 months. 
• Five failures occurred within the first year after pulpotomy treatment. 
• Three of the failures were associated with the loss of the full-coverage restoration
• and the two remaining failures presented with either pain or both pain and soft tissue pathology. 
• During the second year, one tooth presented with both pain and pathologic mobility. 
• Three more teeth presenting with clinical outcomes of pain were observed in the third year. 

A survival analysis estimating the cumulative probability that anyone tooth survived clinically with a 95 per cent bootstrap confidence band is plotted as a survival curve and presented in Figure 1. The probability of survival at both 12 and 24 months remained constant at 99.1 per cent but decreased to 93.7 per cent at 30 months.

This is a summary of the final study sample.

final study sample

• 208 patients (104 male & 104 female)
• mean age: 4.9 ys
• total number of primary molars: 608
• 5 different treatment providers
• mean number of teeth treated for each patient: 2.9

• full coverage
  • SS crown
  • zirconia crown
• the mean number of recalls per →patient: 2.4 visits
• the time between recalls →37-1005 days (mostly within 6-month intervals for the first 18 months)

All teeth received full-coverage restorations, either stainless steel crowns or zirconia crowns. The mean number of recall examinations per patient was 2.4 visits. The time between recall examinations ranged between 37 and 1,005 days; however, most recalls were completed at regular six-month intervals for the first 18 months of the study period.

All information was de-identified, recorded, and compiled on a Microsoft Excel worksheet Data for continuous variables, including the age at treatment, a number of teeth treated per patient, and a number of recall examinations per patient were calculated as means and standard deviations.

Percentages were used to summarize categorical data, including overall clinical and radiographic outcomes, over the study Survival analyses were conducted to estimate the probability of clinical success and radiographic success over the observation time post-treatment for each tooth. Survival curves were estimated by nonparametric maximum likelihood methods for interval-censored data. Statistical analysis was completed using R-project software. A subset of radiographs from the sample population was utilized to determine rater reliability; all radiographs with a failed outcome were included along with a randomized sample of radiographs with successful outcomes at a one-to-two ratio.

data collection :

• • Microsoft excel
  • data for continuous variables →calculated as means and standard deviation
  • percentages →summarize the categorical data
  • survival analysis →probability of clinical/radiographic success 
  • statistical analysis→ R-project software
  • a subset of radiographs→ rater reliability
  • independent evaluation of the radiographs
    • principle investigator
    • practising paediatric dentist 

Independent evaluation of the radiographs was completed by both the principal investigator and a practicing pediatric dentist to determine interrater reliability of radiographic diagnosis. (Also see Paediatric Dentists in Brisbane)

The setting reaction of Biodentine® is initiated when tricalcium silicate interacts with water to form hydrated calcium silicate (CSH) gel and calcium hydroxide.

Hydrated calcium silicate gel, which is impermeable to water, forms on the surface between unreacted tricalcium silicate grains. This tricalcium silicate and CSH gel conglomerate exhibit an intrinsic sealing ability. At the material-tooth interface, calcium hydroxide with surrounding phosphate ions precipitates into a hydroxyapatite-like molecule, which can be incorporated into dentin.

Biodentine is a non-toxic calcium silicate that was introduced by Septodont in 2009

• non-toxic
• nonmutagenic
• calcium silicate
• Septodont in 2009

Calcium silicate interacts with water →hydrated calcium silicate (CSH) gel + CaOH

CSH gel→ impermeable to water forms on the surface between unreacted tricalcium silicate 

intrinsic seal ability

(Arora et al. 2013)

material tooth interface→ CaOH & phosphate ions →hydroxyapatite like molecules

 (Arora et al. 2012 & Priyalakshmi and Ranjan 2014)

The high alkalinity of calcium hydroxide also stimulates the reparative process of osteoblasts. Through these two mechanisms of action, Biodentine® develops both an intrinsic seal and a seal at the material-dentin interface. Biodentine®’s ability to form a seal against bacterial microleakage and stimulate pulpal reparative processes within the tooth, as well as its reduced setting time, make it a promising dental material for clinical use in vital pulp therapy.

↑the alkalinity of CaOH reparative process of odontoblasts

(Carrotte 2004)

intrinsic seal and seal at material-dentine interface

promising  material in clinical use for vital pulp therapy 

• seal against bacterial microleakage
• stimulate pulpal repair
• reduced setting time

The previous nine studies that fulfilled the inclusion criteria of a 2018 systematic review and meta-analysis on mineral trioxide aggregate (MTA) and Biodentine® have sample sizes ranging from 22 to 90 patients and 20 to 45 teeth. 2019 meta-analysis reviewed these same studies and had comparable findings. Most reports in the literature

reviewing primary molar Biodentine® pulpotomies have monitored posttreatment outcomes over six to 12 months, with fewer studies reviewing up to 18 to 24 months.

Systematic reviews: 

Stringhini et al. 2018 &  Shafaee et al. 2019

• 9 studies
• MTA & biodentine
• 22-90 patients
• 20-45 teeth
• comparable findings

the purpose of this study was to evaluate the clinical and radiographic success of pulpotomy outcomes using Biodentine® with larger sample size and longer follow-up period than previously published.

Aim:

• the clinical and radiographic success of pulpotomy outcomes using Biodentine 
• larger sample size
• longer follow up period

This was a retrospective study conducted in a paediatric specialist dental group in Vancouver with ethics approval.

Methods:

• the private paediatric dental group
• Vancouver 
• retrospective chart review
• ethics approval

Outcome variable

three-round Delphi survey

clinical failure

• pain
• soft tissue pathology
• pathological mobility

radiographic failure

• pathological radiolucency
• pathological root resorption

(Smail- Faugeron et. al 2013)

These five outcome variables were used to determine the success of biodentine as a pulpotomy medicament in the current study

study sample

• CORGA
• Jan 1, 2013- May 1, 2018

inclusion criteria

• at least one primary molar that received biodentine pulpotomy
• restored with full coverage restoration
• minimum one recall 

Dental treatment provided under general anesthesia with rubber dam isolation by one of five certified pediatric dentists in the practice. All practitioners followed the same protocol for performing pulpotomies after caries removal resulted in a pulp exposure: cavity preparation with a high-speed handpiece and water spray followed by coronal pulp amputation with a slow-speed round bur, sterile water irrigation, the achievement of radicular hemostasis with slightly moistened cotton pellet application, and placement of Biodentine® in the chamber over the amputated pulp stumps. A layer of reinforced zinc oxide-eugenol was used to fill the rest of the pulp chamber and a full-coverage restoration was immediately placed with a glass ionomer cement while the Biodentine material completed its 12-minute setting time.

• GA
• rubber dam isolation
• ⅕ paediatric dentists 
• same protocol for pulpotomies was followed 
• cavity preparation /coronal pulp amputation/ sterile water irrigation/ radicular hemostasis /Biodentine/ reinforced zinc oxide-eugenol /full-coverage restoration with a glass ionomer cement

Data Collection

Data was collected for each patient. pulpotomy was followed until exfoliation, extraction, or until the last date a recall evaluation was noted on the patient’s chart.

data collected for each patient 

• gender
• treatment provider
• tooth number
• type of final restoration
• age at treatment
• age at subsequent recall
• biodentine pulpotomy→ followed till exfoliation/ extraction/ last recall 

Radiographic failure

• pathological radiolucency/ pathological root resorption 
• unless evidence that the eruption of succedaneous permanent tooth 

radiographs

• digital
• analog LED →radiograph viewing digitized with a digital single-lens reflex camera 

radiographs excluded

• artifact
• motion artifact
• furcation not visible less than half the root length was visible

The two radiographic outcomes indicating failure of the Biodentine® pulpotomy were pathologic radiolucency and/or

pathologic root resorption. A finding of root resorption and/or radiolucency was considered pathologic unless there was clear evidence that the eruption of a succedaneous permanent tooth was the precipitating factor for this radiographic finding. Radiographs examined included both digital and analog films. Analog films were visualized on an LED radiograph viewing box and subsequently digitized with a digital single-lens reflex camera Upon digitization, analog films were evaluated for radiographic outcomes.

 Digital films were unaltered for radiographic outcome evaluation. Radiographs were excluded from the study if there was the presence of an artifact or motion artifact, the furcation area was not visible, the mesial and/or distal cementoenamel junction was not visible, and less than half the root length was visible.

Clinical Failure

• pain/pathological mobility/ soft tissue pathology (fistula/swelling)
• missing crown
  • failure before or after loss of crown
  • considered clinical failure 
• exfoliated teeth→ last documented date that the tooth was present
• exfoliation →no clinical/ radiographic outcome → clinical success
• extraction →failure 

The three outcomes that constituted a clinical failure were pain, pathologic mobility, and soft tissue pathology (fistula or swelling).

 If the crown was noted as missing at the recall examination, it was difficult to discern whether the failure of the pulpotomy medicament occurred before or after the loss of the crown. As a result, it was decided that a crown loss constituted a clinical failure.

 For treated teeth that exfoliated and were absent at the time of recall, the decision was made to use the last documented date when the tooth was present. An exfoliated tooth that did not exhibit a failed clinical or radiographic outcome was considered a clinical success. 

A tooth lost due to extraction was regarded as a clinical failure.

There were 461 total radiographs taken over the study period. However, only 270 radiographs met the established diagnostic criteria for inclusion. This enabled a radiographic evaluation of 90 primary maxillary molars and 144 primary mandibular molars. 

The overall 30-month radiographic success rate was 217 out of 234 There were no observable differences in success rates between maxillary and mandibular molars or between primary first and second molars.

There were 17 radiographic failures, of which the majority occurred within the first 18 months after pulpotomy treatment.

• total of 461 radiographs → 270 included 
  • 90 primary maxillary molars
  • 144 primary mandibular molars
• overall 30-month radiographic success rate 217/234
• maxillary molars=mandibular molars 
• first primary molars= second primary molar
• 17→ radiographic failures →majority in the first 18 month

There were seven teeth with pathological root resorption, five teeth with pathological radiolucencies five teeth with signs of both pathologic radiolucency and pathologic root resorption. 

• pathological root resorption →7
• pathological radiolucency→5
• pathological radiolucency & root resorption →5

clinical & radiographic outcome

The cumulative probability of clinical survival was 93.7 per cent and radiographic survival probability was 85.6 per cent during the 30-month posttreatment period. The majority of failed Biodentine® pulpotomies occurred before 18 months. Of the 20 failed primary molar Biodentine® pulpotomies, six teeth presented with signs of both clinical and radiographic failure, three teeth demonstrated only clinical signs of failure, and 11 teeth were solely radiographic failures (Table 2). Overall, there were 17 patients with failed primary molar pulpotomies, and five children each had two failed treatment outcomes.

• during 30 months
  • clinical survival 93.7%
  • radiographic survival 85.6%
• majority of failures before the first 18 month
• 20 failed primary molars
• both clinical and radiographic failure→ 6teeth 
• clinical failure→ 3 teeth 
• radiographic failure→ 11 teeth 
• 17 patients →with failed primary molars
• 5 children →2 failed treatment outcome 

Interrater reliability of radiographic outcomes was determined between two blinded investigators evaluating 51 radiographs and incorporating radiographs with successful and failed outcomes at a two-to-one ratio. Interrater agreement was 94.4 per cent with a Fleiss’ Kappa statistic of 0.870, which indicates a strong level of agreement.

The cumulative probability that anyone tooth would have no signs of radiographic failure at one year was 97.0 per cent; this decreased to 92.5 per cent at the two-year mark. At 30 months, the probability declined to 85.6 per cent, predominantly due to the lower number of available diagnostic radiographs.

A recent review identified nine studies reporting the clinical and radiographic success rates of Biodentine® pulpotomies in primary molars. Most of these studies had one year or less of follow-up, had small sample sizes of 17 to 43 teeth, and reported success rates of 95 per cent to 100 per cent.

Yet another newly published study noted a 97 per cent Biodentine® pulpotomy success rate over three years, although it had a very small sample size. This study had comparable outcomes, but with the added advantage of both a longer follow-up time and a larger sample size than previous investigations 

recent reviews 

• nine studies clinical and radiographic success rates of Biodentine pulpotomy in primary molars
• one year or less follow up
• small sample size 17-34
• reported success rate of 95%-100%

(Stringhini et al. 2018)

recent RCT 

• 97% success rate over 3 years
• very small sample size                                                                                      
• (Rubanenko et al. 2019)

The use of Biodentine® as a medicament in this study compares favorably to traditional formocresol or ferric sulphate pulpotomies, which have respective clinical and radiographic success rates of 92 per cent and 74 per cent.25 

This may be because, unlike formocresol and ferric sulphate, bioactive materials such as Biodentine® minimize the likelihood of radicular pulp inflammation, which is otherwise associated with pathological root resorption and subsequent pulpotomy failure.

• use of biodentine in this study compares favorably to traditional formocresol or ferric sulphate pulpotomies 
  • clinical success rate 92%
  • radiographic success rate of 74%

(Grech et al. 2013)

• bioactive material →minimize the likelihood of radicular pulp inflammation→ pathological root resorption →pulpotomy failure 

(Papagiannoulis et al. 2002)

The results of this Biodentine® study are analogous to reported success rates using MTA as a pulpotomy medicament. A 24-month randomized trial comparing Biodentine and MTA found that the two medicaments had similar clinical and radiographic results. This is likely due to equivalent mechanisms of action, as both are biocompatible, noncytotoxic, nonmutagenic calcium-silicate materials that can stimulate pulpal healing and regenerative mechanisms. However, an advantage of Biodentine® over MTA in a clinical environment is its shorter setting time.

• Due to the addition of the calcium chloride accelerator in the liquid component of Biodentine®, the initial setting time is approximately 12 minutes, with a final setting time of 45 minutes.
• Comparatively, MTA takes three to four hours for the final set to be completed
• This is of importance for restorative procedures where Biodentine® is utilized as a layer under another restorative material, as is typical when performing direct or indirect pulp therapy. 
• Furthermore, dye leakage studies show significantly better marginal sealing of Biodentine® compared to MTA and glass ionomer cement 
• which could be partly attributable to Biodentine®’s interaction with dentinal tubules via mineral tags
• The results of this study provide support for the use of Biodentine® as an alternative to MTA, especially for clinicians preferring a pulpotomy medicament with a shorter setting time.

• calcium chloride →accelerator in the liquid →initial setting time of 12 mins and final set time 45 minutes 

(Grech et al. 2013 & Malkondu et al. 2014) 

• MTA: 3-4 hours for the final setting

(Holan et al. 2005 & Eidelman et al. 2001)

• important in restorative procedure →direct/indirect pulp capping 
• better marginal seal compared to MTA and GIC 

(Kokate and Pawar et al. 2012)

• interaction with dentinal tubules via mineral tags

(Arora et al. 2013)

An interesting incidental observation was that no failures were associated with placement of a zirconia crown, but the numbers were too small to draw any clinically or statistically significant conclusions from this finding. 

pain/ pathological mobility can be due to:

• Poor tooth selection
• failure of the
• pulpotomy medicament
• failure of the restoration 

However, given the overall high success rate and the minimal number of lost restorations, it is speculated that these clinical failures were most likely a consequence of poor tooth selection.

Incidental observation→ no failures of zirconia crown (small numbers to draw a conclusion )

pain/pathological mobility 

• poor tooth selection (most likely) 
• failure of the
• pulpotomy medicament
• failure of the restoration

Accurate diagnosis of pulpal vitality plays a critical role in the outcome of a pulpotomy; however, no reliable method exists by which an operator can determine accurate pulpal diagnosis at the time of pulpal exposure.

 The colour and volume of blood observed following pulp amputation are considered subjective and, thus, are unreliable markers of pulp status.

A recent investigation measuring the presence of inflammatory cytokine markers to assess the current standard of pulpal hemostasis as an indicator to proceed with a pulpotomy suggests there is no direct correlation between the achievement of hemostasis and the inflammatory status of the radicular pulp.

Ultimately, an accurate preoperative pulp vitality diagnosis and the choice of a full-coverage restoration are key determinants contributing to the clinical success of primary molar Biodentine® pulpotomies.

Radiographic success is similar to previously reported success rates of Biodentine® pulpotomies, which range from 87 per cent to 94 per cent over follow-up periods up to 18 months.

The outcome is also comparable to reported MTA radiographic outcomes of 87 per cent.

However, the findings are more favourable than published radiographic success rates of formocresol and ferric sulfate pulpotomies, which range from 78 per cent to 90 per cent and 70 per cent to 97 per cent, respectively.

radiographic outcome similar to a study reporting

• biodentine pulpotomies
• 87%-94% radiographic success rate
• follow up 18 months 

(Bani et al. 2017 & Rajasekharan et al. 2017 & Juneja and Kulkarni 2017 & Caruso et al. 2018)

• the outcome of this study →compared to an 87% radiographic success rate 

(Cuadros-Fernández et al. 2016)

• more favourable radiographic success rate than formocresol (78%-90%)/ ferric sulphate (70%-97%)

(Peng et al. 2007 & Lin et al, 2014) 

Reported success rates of primary tooth pulpotomies have been inconsistent, partly due to a lack of well-defined, consistent outcome criteria.

To address this limitation, the two radiographic outcome variables identified as the most relevant in defining pulp therapy failure were utilized.

Typically, evaluation of radiographic outcomes utilizes periapical radiographs to visualize the periodontal ligament space and assess for the presence or absence of periradicular or furcation radiolucencies. Although this study relied upon bitewing films taken during periodic recall evaluations, there are differences to consider when performing a radiographic evaluation of the primary dentition compared to the permanent dentition. Upon radiographic examination of a primary molar, a pathologic radiolucency secondary to a pulpal necrosis may not present periapically—a typical finding in the permanent dentition. Rather, primary molars have a high prevalence of furcal accessory canals resulting in pathological furcation radiolucencies secondary to a necrotic pulp.

• lack of well defined, consistent outcome criteria 

(Smith et al. 2000)

• two radiographic outcomes most relevant in defining pulp therapy 

(Smail-Faugeron et al. 2013)

• periapical radiograph PDL space/assess the presence or absence of periradicular or furcation radiolucency (AAE)
• bitewing radiographs →difference to consider in  in primary and permanent dentition 
• primary molar →pathological radiolucency →not apical→ furcal 

(Ringelstoen and Seow 1989)

The low radiographic failure rate of this study suggests that routine periapical radiographs of primary molars following a pulpotomy are not recommended in the absence of any clinical signs or symptoms of failed pulp therapy. Furthermore, most of the radiographic failures occurred within the first 18 months after treatment, which additionally excludes the need for periapical radiographs to follow primary molars receiving pulpotomies until exfoliation. These results support the currently recommended radiographic intervals recommended by the American Dental Association.

Low radiographic failure

• routine PA of primary molars not recommended in the absence of any clinical signs/symptoms
• most failure within 18 months
• excludes the need for PA to follow primary molars receiving pulpotomies  until exfoliation
• Support current radiographic  intervals recommended by ADA

The study results are consistent with previous pulp therapy studies in that the observed radiographic success rate was lower than the clinical success rate. Radiographic failure does not consistently correlate with indicators of clinical failure such as pain, pathologic mobility, or soft tissue pathology. For instance, a tooth with internal root resorption, although considered a radiographic failure, may not present with any clinical symptoms. Radiographic interpretation can also be difficult in the primary dentition, as it may be challenging to differentiate between changes caused by pathologic versus physiologic exfoliation processes that employ identical cellular mechanisms of resorption. Hence, careful monitoring may be the preferred management in instances of radiographic failure, with extraction only being considered if signs of clinical failure develop.

• radiographic success rate ↓clinical success rate 

(Bani et al. 2017 & Cuadros- Fernandez et al. 2016 & Juneja and Kulkarni 2017 & Kusum et al. 2015 & Caruso et al. 2018)

• radiographic failure doesn’t consistently correlate with clinical failure 

(Waterhouse et al. 2000)

• difficult interpretation of radiographs in primary dentition 
  • challenging to differentiate between pathological and physiological changes 

(Kamat et al. 2013)

• careful monitoring 

This study presented with limitations that warrant consideration. As a retrospective study, it was reliant upon the accuracy of the dentists’ clinical charting to help determine the signs and symptoms of clinical failure. Also, many of the children were referred to this specialty practice for general anesthesia due to their young age and/or inability to cooperate. These patients tended to return for a limited number of follow-up appointments before returning to the referring dentist. Therefore, a survival analysis was conducted to accommodate for the wide variability of patient follow-up times. However, the study design permitted a larger sample size and a longer follow-up period than any previously published primary tooth Biodentine® pulpotomy studies.  It also allowed for minimal selection bias because all teeth treated within the study period were included.  As all teeth were restored with full-coverage tooth restorations under general anesthesia for children, this may have minimized potential confounding factors resulting from uncooperative behavior or restoration microleakage. Finally, the decision to use a consistent set of outcome variables will allow for easier comparisons of these results with future pulpotomy studies.

• limitations
  • accuracy of clinical charts→ determine signs and symptoms of clinical failure
  • referred for GA →young age, unable to cope with treatment  
  • limited follow-ups →survival analysis 
  • this study design→ larger sample size/longer follow up period
  • ↓ selection bias →all teeth treated were included 
  • full coverage restoration under GA → confounding factor 
  • a consistent set of outcomes →easier comparison in the future studies

(Smail-Faugeron et al. 2013 & Coll et al. 2017)

based on this study’s results, the following conclusions can be made:

2. Pulpotomy procedures completed for primary molars utilizing Biodentine® as the pulpal medicament had favorable clinical and radiographic results after 30 months.
3. Biodentine® can be considered an alternative to other commonly used primary tooth pulpotomy medicaments.

Anaesthetic efficacy of articaine versus lidocaine in children’s dentistry: a systematic review and meta-analysis

Tong et al. 2018 IJPD

Anesthetic Effectiveness of Articaine and Lidocaine in Pediatric Patients During Dental Procedures: A Systematic and Meta-Analysis

Taneja et al. 2020 PD

• a more thorough assessment of the studies according to Prisma guidelines but due to the heterogeneity of the studies a meta-analysis could not be conducted. they have concluded that there is low-quality evidence suggesting that there is no difference between articaine and lidocaine during the procedure but less pain with articaine after the procedure.

Tong et al. 2018 

• Included 5 more studies of low quality but concluded that articaine was significantly better than lidocaine.

Taneja et al. 2020 

Title and abstract were concise.  Adding clinical and radiographic success would be helpful. The introduction was concise.

tile and abstract: 

• informative and balanced summary of the article 

keywords:

• clinical and radiographic success 

introduction

• a good summary of pulpotomy and biodentine 
• concise 

As part of STROBE guidelines it is recommended that key elements of the study design to be presented in the methods section, which has not been the case in their article. The setting has not been specified, it has been mentioned under GA but were they all in one hospital? From how many practices? Who performed the follow-ups? The same operators? Where they referred back to referring dentists?

The age of patients not specified ( this could affect the number of exfoliated teeth that have been accounted for the success, they may have had some symptoms or radiographic failures that were not picked up), the study only mentions meaning age of 4.9

Who had done the consultation and diagnosis prior to Rehab under GA?

Has been mentioned in the article that the subjects were followed up until exfoliation of teeth, extraction or last recall. If some subjects only came for 1 recall ( 6 months) it is not really a 30 month follow up. How have they addressed this?. 

Radiographic evaluation: how often were the radiographs taken? Ethics. Why were 2 different radiographs  Digital and analog used in the same practice?

Methods:

• key elements
• Setting
• age
• follow-ups
• radiographs  

Retrospective analysis: according to records and what has been provided.

Results

• the time between recall exams – ranges greatly from 37-1005
• the extent of caries, ICDAS coding of failed pulpotomies 
• caries into the pulp before removing caries?
• Retrospective study limitations

The authors have given a detailed description of why data was excluded. 

• well categorized into 
  • clinical
  • radiographic
  • clinical & radiographic

Some of the limitations were addressed.

In regards to initial diagnosis, has not mentioned who has done the diagnosis before tx. Nad from the radiographs that were excluded was any of them from pre- p of the included subjects in the study? The age of patients has not been recorded. How many of the ~ 600 pulpotomies were over 7 years old? They have just mentioned the mean age of ~4

Discussion 

• lengthy
• repetition of results 
• limitations:
  • diagnosis at the time (colour & duration of bleeding)
  • age of patients
  • radiographs   

The radiographs were not taken with the same holders, not standardized.  

Discussion:

• standardized radiography technique 
• 5 operators
• retrospective study: relying on recorded data 
• no source of funding mentioned 

There have been many similar studies, most pulpotomy medicaments have a 90% success rate if used with a correct diagnosis.

Does the study add ay value?

We think a study looking at teeth with questionable diagnosis ( prolonged bleeding, etc) should be conducted looking at biodentine and other medicaments to see if the success rate of the questionable teeth would be better with biodenitne. This ideally should be done in patients receiving dental treatment in the chair, that are cooperative.  

Success

• correct diagnosis
• good seal 
• medicament not as important

MTA and biodentine for primary teeth pulpotomy: a systematic review and meta-analysis of clinical trials   

(Stringhini et al. 2018)

There is no superiority of one material over the other, MTA versus biodentine

Comparison of the success rate of a bioactive dentin substitute with those of other root restoration materials in pulpotomy of primary teeth: Systematic review and meta-analysis

(Shafaee et al. 2019)

All of the included studies had an unknown or high risk of bias. On the basis of the Grading of Recommendations Assessment, Development and Evaluation scale, the quality of evidence for the comparison of MTA and Biodentine was moderate. Biodentine had a statically significantly higher radiographic failure rate than did MTA at 6 and at 9 through 12 months after pulpotomy. The authors found no substantial differences between the clinical failure rates of Biodentine and MTA and the radiographic or clinical failure rates of Biodentine and formocresol or of Biodentine and ferric sulphate.