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ORIGINAL ARTICLE
Year : 2021  |  Volume : 39  |  Issue : 3  |  Page : 303-309
 

Comparative evaluation of diode laser and simvastatin gel in pulpotomy of primary molars: A randomized clinical trial


1 Department of Pedodontics and Preventive Dentistry, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India
2 Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India
3 Department of Conservative and Endodontics, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India

Date of Submission16-Feb-2021
Date of Decision09-Jul-2021
Date of Acceptance03-Sep-2021
Date of Web Publication22-Nov-2021

Correspondence Address:
Dr. Kalpana Bansal
Department of Pedodontics and Preventive Dentistry, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi - 110 029
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jisppd.jisppd_60_21

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   Abstract 


Background: Pulpotomy is a vital pulp therapy performed in carious pulp exposures in teeth in which the inflamed coronal pulp is removed and medicament is placed to conserve the vital root pulps. Recently, simvastatin which is a cholesterol-lowering drug has been found to be associated with the pulp regenerative potential. Aim: The aim of this parallel two-arm randomized control trial was to evaluate and compare the clinical and radiographic efficacy of diode laser (DL) and simvastatin gel (SG) in pulpotomy of carious primary molars. Methods: Hundred primary molars (in 98 children, 65 males, 33 females with age 4–8 years) requiring pulpotomy were randomized into the DL or SG group. Pulpotomy was performed as per the standardized protocol; thereafter, all teeth were restored with resin modified glass ionomer cement followed by stainless steel crowns. Follow-up evaluations were done at 3 and 12 months using clinical and radiographic criteria. Statistical analysis was done using Chi-square test at a significance level of 0.05. Results: At 12 months, out of 92 teeth available for clinical and radiographic evaluation by blinded evaluators, DL group showed clinical and radiographic success rates of 76.1% and 52.1%, while SG group showed 80.4% and 65.2% success rates, respectively. There was no statistically significant difference between the efficacy of two techniques clinically (P = 0.49) or radiographically (P = 0.30). Conclusions: Both SG and DL had similar efficacy for primary tooth pulpotomy, clinically and radiographically after 12 months. Considering its ease of application and low-cost, SG can be recommended as a potential pulpotomy medicament in primary molars.


Keywords: Diode laser, primary molars, pulpotomy, randomized clinical trial, simvastatin, vital pulp therapy


How to cite this article:
Aripirala M, Bansal K, Mathur VP, Tewari N, Gupta P, Logani A. Comparative evaluation of diode laser and simvastatin gel in pulpotomy of primary molars: A randomized clinical trial. J Indian Soc Pedod Prev Dent 2021;39:303-9

How to cite this URL:
Aripirala M, Bansal K, Mathur VP, Tewari N, Gupta P, Logani A. Comparative evaluation of diode laser and simvastatin gel in pulpotomy of primary molars: A randomized clinical trial. J Indian Soc Pedod Prev Dent [serial online] 2021 [cited 2021 Nov 29];39:303-9. Available from: https://www.jisppd.com/text.asp?2021/39/3/303/330720





   Introduction Top


Pulpotomy is a vital pulp therapy (VPT) procedure found to be effective in preserving the primary and permanent teeth affected by deep caries or trauma. Several medicaments and agents such as formocresol, ferric sulphate, calcium hydroxide, glutaraldehyde, calcium-enriched mixture cement, mineral trioxide aggregate (MTA), and techniques like electrosurgery and lasers have been investigated for their efficacy in pulpotomy of primary teeth with variable success rates.[1] According to the American Academy of Pediatric Dentistry Guidelines,[2] MTA may be the preferred medicament for pulpotomy in primary molars owing to its desirable characteristics such as biocompatibility, sealing ability, induction of hard tissue formation, and seldom reported internal resorption.

Despite so many advantages, there have been a few obstacles that limit the use of this material in clinical practice such as difficult manipulation, discoloration potential, slow setting time, and high material cost.[3],[4] The economic factor is the most relevant one from the perspective of a clinician in a developing country like India. Hence, this factor has always motivated the researchers worldwide to look for low-cost alternatives.[5],[6],[7]

In recent past, usage of Nd: YAG, Er: YAG, CO2, and diode lasers (DLs) has gained popularity for pulpotomy because of their advantages such as better hemorrhage control, absence of mechanical contact, and stimulation of regenerative cells.[8],[9],[10] Among these lasers, diode or soft tissue laser has advantage of causing less thermal damage with accelerated pulpal wound healing.[11] It is because of high-water content of dental pulp leading to increased absorbance of DL wavelengths and resultant energy production in the tissue. Previous studies evaluating the efficacy of DL in pulpotomy of primary molars have demonstrated better success rates in comparison to other medicaments.[12],[13] However, researchers have highlighted certain issues with laser use like technique sensitivity and requirement of specialized and expensive equipment. Another concern has been the risk of thermal damage of the surrounding pulpal tissue, which can result in failure of pulpotomy procedures.[14] A recent systematic review and meta-analysis has concluded that the laser pulpotomy in primary molars shows comparable clinical and radiographic results to other conventional pulpotomy medicaments, including formocresol and MTA.[15]

Recently, simvastatin, a 3-hydroxy, 3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor, a potent lipid-lowering drug, has emerged as a novel medicament in regenerative dentistry. It has been shown to enhance osteoblast function and reduce osteoclast activity, hence inducing bone formation and mineralization.[16],[17],[18] Its regenerative effects have been demonstrated in odontoblastic differentiation of human dental pulp stem cells and formation of reparative dentin.[19],[20],[21] These properties influenced researchers to explore the use of simvastatin as an effective medicament in VPT procedures. Recently, 3Mixstatin (triple antibiotic pastes and simvastatin powder) has been reported to have a remarkable success in pulpotomy of primary molars.[22]

However, on literature review, there is no study which has evaluated the efficacy of pure simvastatin as a pulpotomy agent and further these two agents have not been compared. Hence, this study was planned with an aim to compare and evaluate efficacy of simvastatin gel (SG) with that of DL in pulpotomy of primary molars. It was hypothesized that SG may be equivalent to soft tissue DL technique in pulpotomy of primary molars.


   Methods Top


Study design

A parallel two-arm randomized controlled trial was designed as per the Consolidated Standards of Reporting Trials 2010 statement[23] and registered under the Clinical Trials Registry of India (CTRI) (CTRI No: CTRI/2018/03/012800). Ethics approval was obtained from the Institute Research Ethics Committee (Ref No: IECPG-147/26.04.2017, RT-06/2017). All the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional or regional) and with the Helsinki Declaration of 1975, as revised in 2000.

Sample size

Literature search did not yield any study comparing simvastatin and DL in pulpotomies of primary molars. However, 70% success rate has been reported by Saltzman et al.[10] using DL plus MTA. Taking the same success rate for laser and 95% for simvastatin as a pulpotomy agent on the basis of pilot study conducted in the department, a sample of 43 teeth per group was computed to detect the assumed 25% effect size to be significant in a two-sided Chi-square test with 5% alpha error and 80% power. Giving an allowance for 15% attrition in the follow-up, a sample size of 50 teeth per group was planned.

Study participants

Healthy children of age group 4–8 years with deep asymptomatic carious lesions in primary molars were screened for VPT as per the following criteria: (a) no clinical signs and symptoms of spontaneous pain, abscess/fistula, tenderness on percussion, and mobility and (b) no radiographic evidence of loss of integrity of lamina dura, periradicular or furcal radiolucency, pathological external or internal root resorption, and presence of more than 2/3rd of root length. Only the teeth which had pulp exposure during caries excavation were included in the study, while those which did not have any pulp exposure during caries excavation were treated by indirect pulp therapy. On selection of teeth, the parents were informed about the study and explained about the risks, benefits, and treatment procedures verbally, and written consent was obtained for inclusion in the study by providing an informed consent sheet. Verbal assent was taken from the child before commencement of the procedure. No incentives were given to the participants.

Randomization

The teeth were randomly allocated to two groups; randomization was done using a variable block size, using nQuery Advisor software. The sequence of randomization was obtained from the statistician who was independent of the study. Allocation concealment was done using sealed opaque envelope, stored with the clinic's reception. After a patient's enrolment in the study, the envelope was opened individually to inform the operator about the allocated study group. The selected primary molar was treated either by DL or by applying SG after pulpotomy. Clinical procedure in all teeth was performed by a single dentist, while the follow-up evaluations were performed by two blinded evaluators.

Preparation of simvastatin gel

Pure simvastatin powder (97%) was procured (Batch no: S6196, CAS number: 79902-63-9, Sigma Aldrich Industries Pvt. Ltd, Germany). A carrier gel was prepared based on the study conducted by Stein et al.,[17] in the laboratory of pharmacology by mixing 0.25 g of methyl cellulose powder in 10 ml of distilled water. 1 μM/L concentration of SG[19] was made under aseptic conditions by mixing 0.03 mg of simvastatin powder in the 10 ml of carrier gel using a vortex unit. 0.5 ml of the prepared SG was dispensed in a single use Eppendorf tube and stored at 4°C.

Clinical procedure

Selected primary molars were anesthetized using lidocaine (2%) with epinephrine 1:100,000 administered by inferior alveolar nerve block for mandibular molars and buccal infiltration for maxillary molars. After rubber dam isolation, caries was removed and access cavity was prepared using high-speed carbide burs (size # 2 and # 4). Access cavity was irrigated thoroughly with saline.

In DL group, 940 nm DL (Biolaze Inc, 4 Cromwell, Irivine CA, USA) was used for pulp amputation in contact mode, with 2 watts of power, 4J/cm2 energy, and 70–80 Hz frequency in the gated pulse mode.[12] The pulp ablation was started from periphery of the pulp chamber and slowly moved toward the center with laser irradiation delivered through a fiber optic tip of 300 μm diameter. Once the pulp was separated from walls of the pulp chamber, it was cut smoothly from its base using the same power settings in continuous mode and complete hemostasis was obtained at the orifices. Pulp chamber was then cleaned using a wet cotton pellet. This was followed by restoration of the cavity with resin-modified glass ionomer cement (RM GIC) (Nova glass, light-cured A3 shade, Imicryl, Turkey). Throughout the procedure, laser safety measures were followed as per the recommendations of the American National Standards Institute.[24]

In simvastatin group, coronal pulp was completely removed using a sterilized sharp spoon excavator (size–number 15) and access cavity was irrigated thoroughly with saline. Bleeding from the radicular pulp was stopped using a cotton pellet dampened in saline, placed under pressure for 2–3 min. After confirming the hemostasis at the root canal orifices, SG was taken on with a sterile spoon excavator and placed on radicular pulp stumps. This was followed by placement of a precut 2 mm × 2 mm sheet of sterilized gel foam (CollaCote, Integra Life Sciences Corp, U.S.A) and restoration of cavity by RM GIC placed incrementally to avoid displacement of gel.

Immediate postoperative radiographs were taken to ensure proper sealing of the cavity and preformed stainless-steel crown placement was done after 1 week in all the teeth.

Outcome and follow-up

The primary outcome was the success of pulpotomy technique at 12 months on clinical examination. Clinical success was evaluated by a blinded evaluator and absence of signs and symptoms such as pain, inflammation, abscess/sinus, mobility, and crown failure was taken as clinical success. Radiographic assessment was also done at each follow-up by two independent blinded evaluators for presence of (i) periapical/furcal radiolucency, (ii) pathological internal or external resorption, and (iii) integrity of lamina dura.

Statistical analysis

Data were entered into an Excel sheet and statistical analysis was performed using Stata-16 software (State Corp, College Station, Texas, U. S. A.). Pearson's Chi-squared test was performed to determine the significance of the difference between the success rates of two interventions. Cohen's Kappa statistic was calculated for the agreement between two evaluators of radiographic analysis. For the primary outcome variable, both intention-to-treat (ITT) and per protocol (PP) analysis were carried out. In the ITT analysis, all the patients who were enrolled in the study were analyzed. In PP analysis, only the patients who had strictly maintained the follow-up protocol were analyzed.


   Results Top


Study participants were recruited from August 2017 to April 2018 from the outpatient department of pediatric and preventive dentistry at a tertiary care referral center. A total of 224 primary molars with asymptomatic deep carious lesions were evaluated by caries excavation; 124 were excluded as the pulp exposure did not take place and hence they were treated by indirect pulp treatment. Hundred teeth with pulp exposures were finally included in the study [Figure 1]. Eight patients were lost to follow-up at 3 months (three in DL group and 5 in SG group) as they shifted to other cities. Thus, at the end of the study period, 92 teeth (46 in each group) in 90 children were available for follow-up. Baseline characteristics of the teeth are given in [Table 1]. Pulpotomy was performed in 37 maxillary and 63 mandibular molars in 98 children with a mean age group of 6.1 ± 1.3 years (male: 65 and female: 33). No significant difference was found in the gender or the age between the groups.
Figure 1: Consort diagram

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Table 1: Baseline characteristics of the study participants

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At the end of 3 months, abscess was observed in 9 molars of DL group and 8 molars of SG group. At 12 months, 2 more molars in DL group and 1 more in SG group displayed abscess. However, no statistically significant difference in the clinical success rates was observed between the groups (P = 0.499). Overall clinical success rates at 12 months were 76.1% in DL group and 80.4% in simvastatin group, respectively [Table 2]. No statistically significant difference was observed in the overall success of radiographic parameters between the groups (P = 0.304). Interrater kappa values for two evaluators were 0.97 and 0.96 at 3- and 12-month follow-up, respectively. There was no statistically significant difference between the groups' primary outcome in ITT and PP analysis and are shown as PP analysis [Table 2] and [Table 3]. Subgroup analysis of maxillary and mandibular, first and second molars is presented in [Table 4]. No statistically significant difference has been observed in the outcomes in maxillary and mandibular teeth and first and second primary molars, although simvastatin showed higher clinical success as compared to the DL in all tooth types.
Table 2: Clinical and radiographic success rates at 3 and 12 months in diode laser (n=46) and simvastatin gel (n=46) groups (per protocol analysis)

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Table 3: Clinical and radiographic success rates at 3 and 12 months in diode laser (n=49) and simvastatin gel (n=51) groups (intension to treat analysis)

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Table 4: Sub-group analysis of clinical success (n) of two interventions (diode laser=46; simvastatin gel=46) at 3 and 12 months follow-up on the basis of tooth types

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On radiographic evaluation, at 3 months, periapical/furcal radiolucency was seen in 20 teeth in DL group as compared to 15 in simvastatin group. At 12 months, 2 more molars in DL group and 1 more molar in simvastatin group displayed periapical/furcal radiolucency. At 3 months, internal resorption was observed in 9 teeth in DL group and in 7 in SG group. After 12 months, same was observed in 2 more molars of simvastatin group [Figure 2]. No adverse event was reported in any of the patients.
Figure 2: Radiographic images of pulpectomized teeth showing (a) furcal radiolucency (b)internal resorption and (c) peri-apical resorption

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   Discussion Top


Statins have unique properties of anti-inflammatory potential, angiogenesis induction, osteoblastic, and odontoblastic differentiation.[25],[26] Simvastatin on local application enhances osteoblast function and suppress the osteoclastic activity resulting in bone formation.[26] Pure SG has been reported to have better efficacy in the treatment of furcation defects in chronic periodontitis.[25] Miyazawa et al.[20] elucidated that simvastatin stimulated odontoblastic cells in pulp to form reparative dentin. Jung et al.[21] also studied the anti-inflammatory properties of simvastatin by inducing lipopolysaccharides production in dental pulp cells. These properties of simvastatin make it a potential pulpotomy medicament. To the best of our knowledge, this is the first randomized control trial using pure SG as a pulpotomy medicament which compares its efficacy to the well-established method of DL pulpotomy.

DL has been used as a comparator in the present study, because of its better hemorrhage control, lesser pain, capacity to kill all pathogens in the work zone, small portable machine size, and ease of handling.[27],[28] Moreover, it causes ablation of the limited area on target tissue, leaving adjacent tissues relatively unaffected. It is also assumed that laser beam reduces microbial count in the area by direct killing of bacteria.[28] In the present study, DL pulpotomy demonstrated 76% clinical and 52.1% radiographic success rates at 12 months. A study done by Saltzman et al.[10] also showed similar outcomes. However, it was contrary to studies reported by some authors[12],[13] who have shown 100% success rates on the use of DL as pulpotomy agent. This can be attributed to the placement of a medicament (MTA/ZOE) after the laser ablation of coronal pulp in those studies. High clinical success rates could also be due to lesser sample size and difference in the outcome variables. In terms of radiographic failures, majority of cases in this study displayed periapical/furcal radiolucency followed by internal resorption. The reversible decrease in blood flow in pulp microcirculation due to the heat produced by laser has been suggested as a reason for laser pulpotomy failures by Saltzmann et al.[10] DL itself may also produce thermal damage to the surrounding pulp tissue similar to CO2 laser, which can also be one of the reasons for the failure.[29],[10] Other factors that could have contributed to lower success rate of DL pulpotomy in the present study could be; the learning curve with the technique; case selection and iatrogenic-operator errors.

Success rate of SG as pulpotomy medicament was observed to be 80.4% clinically and 65.2% radiographically at 12 months follow-up period. This could be attributed to the ability of simvastatin to influence the differentiation of the odontoblasts from pulp mesenchymal cells, angiogenesis induction causing enhanced radicular pulp healing and anti-inflammatory action leading to elimination of pulpal inflammation. The in vitro study conducted by Sakoda et al. has proven that simvastatin has inhibitory effects on pro-inflammatory cytokines production such as interleukin-6 (IL-6) and IL-8 due to down regulation of nuclear factor kappa ß and activator protein 1 which are IL stimulators.[30] Since, simvastatin is a novel agent in pulp therapy of primary molars, very few clinical studies have been reported using simvastatin in combination with tri-antibiotic paste (3Mixstatin) in direct pulp capping and pulpotomy with a success rate of 91.9% and 90.5% respectively.[31],[22] The antibiotics used in these studies[31] might have contributed to the elimination of bacteria from the infected pulp tissue, leading to higher success rate than that observed in the present study. The purpose of the collacote gel foam used in the study was to seat the SG on the amputated pulp stumps and act as a barrier between the gel and the restorative material. It was hypothesized that the restorative material (RMGIC) when directly placed over the gel might displace the gel or alter its properties.

The teeth presenting with periapical/furcal radiolucency and/or internal resorption were considered as radiographic failure. Most of the radiographic failures observed at 3 months follow-up did not show any progression in terms of clinical failure at 12 months. This emphasizes that clinical presentation of the tooth should be considered when evaluating the failure of pulpotomy and reaching to a decision on pulpectomy or extraction. However, radiographic finding has been reported as the more realistic criteria by Smith when osseous changes were correlated with clinical signs and symptoms.[32] All the teeth showing clinical failure were taken up for the further treatment. Overall, 20 teeth (23%) showed clinical failure of pulpotomy; 13 teeth were treated by pulpectomy and seven were extracted.

Although the operator in the study could not be blinded due to obvious difference in the techniques in two interventions, however, the clinical and radiographic evaluators were blinded to the group allocation and this forms the strength of the study. Prior sample size calculation, randomization method using sealed envelope and all procedures performed by a single operator are the other strengths. However, there are chances of operator having some bias as the allocation group was disclosed at the time of inclusion of the participant in the study.

The comparison of success rates of simvastatin and DL pulpotomy did not reveal any statistical significance, both clinically as well as radiographically. The analysis revealed a difference of 13% and 4% radiographical and clinical success rates respectively of two pulpotomy techniques which was not statistically significant. Since, this is the first study comparing the efficacy of pure SG medicament with DL as pulpotomy agent hence further long-term studies are needed to be carried out with larger sample size in different settings to evaluate the efficacy of SG as pulpotomy agent. Another limitation was the lack of standardization of radiographs during the follow-up period. However, in spite of the limitations, this study provides information and feasibility to design the future trials with a longer follow-up period. Future studies are recommended to be carried out with larger sample size in different settings to compare the efficacy of two as pulpotomy agents.

Ease of application and low cost of simvastatin makes it a potential pulpotomy medicament. Lack of any adverse reactions to pulp and the surrounding tissues forms an additional advantage. Ease of preparation can be utilized to its advantage, it can be further compared with currently available medicaments like MTA and biodentine for efficacy as puloptomy agent.


   Conclusions Top


Within the limitations of the present study, this evaluator blinded double-arm parallel trial revealed that SG and DL had similar efficacy for primary tooth pulpotomy, clinically and radiographically after 12 months. This suggests that pure SG can also be considered as an alternative medicament for vital pulp therapies in primary teeth because of the ease of application and low cost.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  2005 - Journal of Indian Society of Pedodontics and Preventive Dentistry | Published by Wolters Kluwer - Medknow 
Online since 1st May '05