|Ahead of print publication
Pulp therapy of primary molars using lesion sterilization tissue repair and traditional endodontic treatment
Prerna Beniwal, Namita Kalra, Rishi Tyagi, Amit Khatri
Department of Paedodontics and Preventive Dentistry, University College of Medical Sciences (Delhi University) and GTB Hospital, Delhi, India
|Date of Web Publication||14-Oct-2019|
Department of Paedodontics and Preventive Dentistry, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi - 110 095
Source of Support: None, Conflict of Interest: None
Aim: This study aimed to compare the clinical and radiographic success of lesion sterilization and tissue repair (LSTR) therapy and traditional endodontic treatment for pulp therapy of primary molars over a period of 6 months.
Materials and Methods: Fifty primary mandibular molars from children aged 3–8 years in need of pulp therapy presenting with signs of irreversible pulpitis and those meeting our inclusion criteria were selected for the study. The teeth were randomly divided into two groups: Group 1 individuals received intervention by LSTR therapy and Group 2 individuals were treated with the principles of traditional pulpectomy procedures using a mixture of zinc oxide (ZnO) and calcium hydroxide (Ca(OH)2) as the obturating material. Patients were reviewed clinically and radiographically at 1, 3, and 6 months.
Results: At the end of 1 and 3 months, both the study groups were comparable in their overall success rates. At 6 months, the clinical success was comparable between the two study groups. Radiographic success rate of the two study groups achieved statistically significant difference, with Group 2 faring better than Group 1.
Conclusion: Primary mandibular molars showing signs of irreversible pulpitis, particularly those which were destined to have a poor prognosis, were successfully treated in Group 1 using LSTR and in Group 2 with traditional endodontics using a mixture of Ca(OH)2 and ZnO as obturating material.
Keywords: Children, lesion sterilization and tissue repair, primary teeth, pulp therapy, traditional endodontics
|How to cite this URL:|
Beniwal P, Kalra N, Tyagi R, Khatri A. Pulp therapy of primary molars using lesion sterilization tissue repair and traditional endodontic treatment. Saudi J Oral Sci [Epub ahead of print] [cited 2020 Aug 9]. Available from: http://www.saudijos.org/preprintarticle.asp?id=269030
| Introduction|| |
Teeth with infected root canals, particularly those in which infection has reached the periradicular tissues, are a common problem in primary dentition. Preservation of the primary tooth is the best space maintainer for the successor, once resolution of the pathological process is achieved. Endodontic therapy, when feasible, is a superior choice to extraction in primary teeth with irreversible pulpitis, and they should be retained until their exfoliation is chronologically appropriate.,,
Conventionally, ZnOE has been the material of choice for filling the root canals of deciduous teeth. Clinical studies conducted on animals and humans have shown the success rate of ZnOE to range from 65% to 95%., Recently, there have been concerns about the possible detrimental effects of residual ZnO filler particles and cytotoxic effects of eugenol.,,,,,,, Concerns about these shortcomings of ZnOE led to a search for alternative root canal-filling materials for deciduous teeth. Calcium hydroxide (Ca (OH)2), virtually an all-purpose medicament in dentistry, has been widely used in permanent teeth. Its use as a root canal-filling material in primary teeth following pulpectomy has been reported by a few authors with considerable success.,,, However, it was seen to deplete from the canals much before root resorption. In the present study, in an attempt to overcome the drawbacks of both the materials, a mixture of calcium hydroxide and zinc oxide (ZnO) was used as an obturating material.
Endodontic treatment of primary teeth is more challenging than that of their permanent counterparts; this is because of the anatomical complexities of their root canal systems and their proximity to the developing permanent tooth, coupled with the difficulty in behavioral management in children. Therefore, there was a need of a clinical procedure which was simple and minimally invasive and achieved maximum elimination of bacteria from the root canal system without depending much on mechanical procedures.,, The Cariology Research Unit of the Niigata University School of Dentistry, Japan, has developed the concept of “lesion sterilization and tissue repair therapy” (LSTR) or noninstrumental endodontic treatment. Extensive, in vitro and in situ studies have been conducted showing that the mixture of three antibacterial drugs (3Mix) can sterilize carious lesions, necrotic pulps, and infected root dentine of primary teeth.,,,,,
Till date, there have been limited clinical and radiological studies that compare the technique of LSTR with conventional endodontic procedures in primary root canal treatments. Thus, this prospective, single-blinded randomized clinical trial was designed to compare the clinical and radiographic outcome of LSTR and pulpectomy using a mixture of Ca(OH)2 and ZnO as filling material for endodontic treatment of poor-prognosis primary teeth.
| Materials and Methods|| |
Children aged 3–8 years in need of pulp therapy in primary mandibular molars were recruited from the outpatient settings of the Department of Paedodontics and Preventive Dentistry, University College of Medical Sciences and Guru Teg Bahadur Hospital, Delhi. Primary molars presenting with signs of irreversible pulpitis with gingival sinus, or fistula showing periapical or furcal radiolucency, were selected. All teeth were restorable with at least 2/3rd root length. Teeth with excessive root resorption, pulpal perforation, and with infection extending to involve the permanent tooth bud were excluded from the study. Patients with any medical condition making them unfit for the endodontic procedure or drug allergy to any of the drugs to be used were not included. The sample size was fixed to 25/group, based on the similar study done by Nakornchai et al. Individuals were randomized between the two groups, namely, Group 1 and Group 2, by simple random sampling technique using a computer-generated random table:
- Group 1 (n = 25) individuals received intervention by LSTR therapy
- Group 2 (n = 25) individuals were treated with the principles of traditional pulpectomy procedures using a mixture of ZnO and Ca(OH)2 as the obturating material.
The procedure of noninstrumentation endodontic treatment used in this study followed the standard techniques and procedures. The chemotherapeutic agents used, ciprofloxacin (Ciplox IP, Cipla, Mumbai, India), metronidazole (Flagyl 400, IP, Abbott, Mumbai, India), and minocycline (Cynomycin, IP, Wyeth, Mumbai, India), were pulverized into powder in a mortar and pestle after the removal of the enteric coating on the drugs. These powdered drugs were used at a ratio of 1:1:1 as the 3Mix. A mixture of macrogol (M) and propylene glycol (P) was used as a carrier to facilitate better diffusion of medicament through root canal dentin and the surrounding periradicular tissues. The vehicle, of an ointment consistency, was prepared separately by mixing macrogol and propylene glycol at a ratio of 1:1 (by volume).,, The 3Mix antibiotics and MP vehicle were thoroughly mixed at a ratio of 7:1 for standard consistency just before use to form 3Mix–MP ointment. Inferior alveolar nerve block, if needed, was administered prior to the procedure using lignocaine hydrochloride 2% with 1:100,000 adrenaline. The tooth to be treated was isolated using a rubber dam. Access opening was performed using a straight high-speed no. 9 bur. Previous restoration, if any, and the necrotic pulp were removed with a sterile spoon excavator and irrigated with 2.5% sodium hypochlorite (NaOCl). Hemorrhage, if present, was controlled by applying cotton pellets immersed in 10% NaOCl to stop bleeding, to remove both organic and inorganic components of the smear layer, and to eliminate bacteria efficiently at the dentin surface. The pulpal floor was covered with the 3Mix–MP and then sealed with glass-ionomer cement (GIC) (Fuji IX; GC, Tokyo, Japan).
Commercially available ZnO powder (Septodont Healthcare India Pvt. Ltd, Panvel, Maharashtra, India) and Ca(OH)2 paste (Cal-Excel, Ammdent, Mohali, Punjab, India) were used for pulpectomy. To standardize the quantity of each ingredient in the mixture, 70 mg of zinc oxide powder was preweighed, placed in empty capsules, and sterilized. Just before the procedure, a standard length of 7.5 cm of Ca (OH) paste was placed on the mixing pad, and the ZnO powder from the preweighed capsule was emptied beside it. The two were mixed together along with drops of 0.9% normal saline solution to achieve the desired consistency., Treatment was performed using standard techniques and procedures. In 19 of the 25 teeth, a single-visit pulpectomy procedure was performed. The remaining teeth were treated in two visits due to a great deal of gingival swelling and discharge. Access was gained using the same standard techniques and protocol as used with the LSTR group. Working length was established, and complete extirpation of any remaining pulp tissue was carried out using barbed broaches. The root canal was enlarged; starting with a size 15 H-file used in pull-back action, symmetrically increasing the canal's diameter up to size 35 for mesiobuccal/mesiolingual and distobuccal/distolingual canals of primary mandibular molars. All instrumentations were kept 1 mm short of the apex. The root canal was irrigated with 2.5% NaOCl after each instrumentation size. After completing instrumentation, the root canal was irrigated with physiological saline. In six cases, the canals had excessive bleeding or pus exudates; they were dried using paper points. Ca(OH)2 mixed with distilled water to creamy consistency was used as an intracanal medicament filled into the canals using a lentulospiral. Patients were recalled after a week, and if found to have no signs and symptoms, the canals were irrigated with 2.5% NaOCl and dried to resume the procedure. In all the cases, the canals were dried by using appropriately sized paper points, with the size of the last used H-file. The paste was transported into the root canals for each tooth using a hand-held lentulospiral. The process was repeated 5–7 times for each canal until the canal orifice appeared filled with the paste. The pulp chamber was covered with rapid-setting zinc oxide eugenol cement (Dentsply Caulk, Dentsply, India), and a cotton pellet was used to spread the intermediate restorative material on the pulpal floor.
In both the study groups, permanent restorations in the form of GIC (Fuji IX, GC, Japan) or stainless steel crowns (3M, ESPE Germany) were placed, and immediate postoperative radiographic examination was performed. After the clinical procedure has been performed in both the groups, clinical and radiographic evaluations were performed at 1-, 3-, and 6-month intervals.
The clinical success was defined by resolution of spontaneous pain, absence of gingival abscesses, abnormal mobility, pain to percussion, sinus opening, and discharge from sinus. The radiographic success criteria were static or reduced bifurcation/periapical radiolucency, no progression of pathologic internal/external root resorption, and absence of any newly formed radiographic lesions. Calcified changes were recorded but not regarded as a treatment failure. Apart from all the radiological parameters of success that were evaluated, we observed two more factors, namely re-establishment of continuity of the lamina dura and evidence of bone regeneration in the two study groups. The observations were recorded at 3- and 6-month interval but were not used as contributing factors to success or failure.
Data management and statistical analysis
Bonferroni correction was used to adjust P < 0.05. The specificity and sensitivity of the clinical and radiological findings were assessed using clinical findings as the gold standard.
Chi-square (Fisher's) test was used for categorical data between the groups. One-sample binomial test was used to compare paired (before and after) data.
| Observations and Results|| |
Fifty children, 3–8 years of age with a mean age of 5.59 ± 1.24 years, were recruited, and the two treatment groups were comparable with respect to age and sex distribution. Out of the total of fifty primary mandibular molars, 60% were second primary molars and 40% were first primary molars. Clinical and radiological evaluation was done at baseline and at 1, 3, and 6 months, and success was determined on the basis of the predetermined criteria.
Baseline characteristics of the two groups
Clinically, out of the fifty teeth recruited, spontaneous pain, gingival abscess, abnormal mobility, tenderness on percussion, sinus opening, and discharge from sinus were observed in 88%, 100%, 44%, 54%, 62%, and 58%, respectively [Table 1]. Radiologically, furcation radiolucency, periapical radiolucency, internal resorption, and external resorption were present in 100%, 22%, 8%, and 4% cases, respectively [Table 2]. Clinical and radiological parameters were comparable in both groups.
Clinical profile of the study groups at 1, 3, and 6 months
No extraction was required by the end of the 1st month; however, one tooth from Group 1 was extracted by the end of the 3rd month and three teeth from Group 1 were extracted by the end of the 6th month. None of the teeth in Group 2 required extraction.
Clinical success of the procedure, as defined by the absence of all the six clinical features studied, was observed to be 88% in Group 1 and 92% in Group 2 at the end of 1 month; 84% and 100% in Groups 1 and 2, respectively, at the end of 3 months; and 76% and 100% in Groups 1 and 2, respectively, at the end of 6 months, and it was comparable in both groups at three observation points [Table 3]. However, we observed that, at 6 months, 100% of the individuals were free of spontaneous pain in Group 2 as compared to 76% in Group 1, and this difference was found to be statistically significant (P = 0.022).
|Table 3: Comparison of clinical profile of the two study groups at 1, 3, and 6 months|
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Radiological profile of the study groups at 1, 3, and 6 months
Radiological success, defined as the presence of all radiological markers as mentioned in [Table 4], was observed to be 79% in Group 1 and 68% in Group 2 at 1 month and 68% and 76% in Groups 1 and 2, respectively, at 3 months, and this was comparable in both groups at these observation points. However, at 6 months, radiological success rate was observed to be 44% and 76% in Groups 1 and 2, respectively, and it was statistically significantly higher in Group 2 (P = 0.0056).
|Table 4: Comparison of radiological profile of the two study groups at 1, 3, and 6 months|
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Further comparison of radiological parameters among the study groups at 6 months revealed static/decreased furcation radiolucency in 48% in Group 1 and 76% in Group 2, and it was statistically significantly higher among Group 2 (P = 0.041). Of particular mention, there was an appearance of new lesions in 40% of Group 1 individuals and 8% of Group 2 individuals (P = 0.018).
Overall success, defined as meeting criteria for both clinical and radiological success, was observed in 76% in Group 1 and 68% in Group 2 at 1 month and 68% and 76% in Groups 1 and 2, respectively, at 3 months, and it was comparable among the two groups at these observation points. However, applying the null hypothesis and taking null P = 0.20, we applied one-sample binomial test to check the significance of the overall success achieved in both the groups. We observed P = 0.00 < 0.001, implying that the success rate of 68% (Group 1) and 76% (Group 2) is highly significant from the treatment we rendered to save poor-prognosis teeth. At 6 months, the overall success rate was found to be 44% and 76% in Groups 1 and 2, respectively, and it was statistically significantly higher in Group 2 (P = 0.0056).
Hence, the overall success rate of both the study groups was comparable at 1- and 3-month follow-up. Individuals that received LSTR therapy showed marked decline in the success rate in radiographic evaluation, and it was found to be statistically significant (P = 0.0056).
Re-establishment of continuity of lamina dura
At 3 months, re-establishment of the lamina dura was observed in none of the Group 1 cases but 16% of Group 2 cases, however statistically nonsignificant. At 6 months, it was observed in 4% of Group 1 cases and 48% of Group 2 cases and was statistically significantly higher in Group 2 (P = 0.001).
Evidence or bone regeneration in previous bone loss areas was found to be 0% in Group 1 and 44% in Group 2 at 3 months (P = 0.00). At 6 months, it was found to be 40% in Group 1 and 76% in Group 2 (P = 0.021).
| Discussion|| |
At 1-month review
In Group 1, clinical success rate was observed to be 88% at 1 month, which is slightly less compared to the study by Takushige et al. who observed a clinical success rate of 100%. This can be partly due to the fact that they performed re-treatment with 3Mix–MP in cases with persistent symptoms at 1 week, which was not possible in our study design. We found radiologic success rate of 68% at 1 month, while radiologic evaluation was not included in the study by Takushige et al. However, increase in furcation radiolucency was observed in 32% cases of the study group at 1 month. It was often seen in the areas of erupting succedaneous teeth at the time of root resorption, and it was difficult to differentiate the cause of the radiolucency. On the other hand, in Group 2, at 1-month review, no extractions were done, and there was no physiological exfoliation of any tooth. Clinical and radiological success rate was observed to be 92% and 68%, respectively, implying that filling of canals with a mixture of Ca(OH)2 and ZnO was successful in the prompt control of signs and symptoms.
At 3-month review
The clinical success rate was 84% and the radiological success rate was 68% in Group 1. One treated tooth had to be extracted due to treatment failure. The three cases that presented with signs and symptoms represented an extreme from the spectrum of poor-prognosis cases. Whereas in Group 2, a clinical success rate of 100% was observed, which was markedly better with the results of Chawla et al. Radiographically, the success rate improved to 76% from the previous rate of 68% at 1 month, signaling toward a relatively faster rate of bone regeneration in previous bone loss areas with traditional endodontics. Drawing a cross comparison was difficult as we could not find a similar study that had evaluated the cases at 3-month interval.
At 6-month review
In Group 1, the clinical and radiological success rates were 76% and 44%, respectively, and we had three extractions due to treatment failure; the rationale behind the extractions was an evident clinical failure with re-emergence of signs and symptoms. A significant drop in the radiological success rate of LSTR in our study was contributed by the appearance of new lesions and increase in furcation radiolucency, which were observed in 40% of cases. These findings can be possibly due to an inflammatory response to the drugs being used, as it has been already documented that the medicament can produce vascular changes in the pulp leading to granulation tissue formation. Nakornchai et al. documented a 100% clinical success at 6 months of both the study groups, namely, 3Mix and Vitapex ®, whereas the corresponding radiographic success was 84% and 80%, respectively, and the differences were statistically insignificant. The success rate of LSTR observed in our study is considerably lower as compared to that of Nakornchai et al., and it may be due, in part, to the differences in baseline criteria. Gingival abscess and furcation radiolucency were present in all our cases as compared to only 10% and 74%, respectively, in the study by Nakornchai et al. This made our study more skewed toward the management of poor-prognosis teeth. Nevertheless, an overall success rate of 44% at 6 months in the LSTR group in our study is comparable to the results observed by Trairatvorakul and Detsomboonrat  who found both clinical and radiological improvements at 6-month review in 53.2% of their study participants. Agarwal et al. observed an overall success rate of 39% with LSTR at the end of 6 months in their study. They excluded teeth with evidence of radicular pulp degeneration, pathologic mobility, sinus or fistula, radiographic signs of pathologic root resorption, and furcation radiolucency. Whereas, all these parameters were the part of inclusion criteria for case selection in our study, making the cases in the present study prognostically worse. Therefore, even with cases representing a wide spectrum of pathosis in our study, we noticed slightly higher success rate in LSTR group as compared to their study. Rigorous criteria for evaluation were used in the present study vis-à -vis study by Agarwal et al.
A clinical success rate of 76% in LSTR group is suggestive of its importance in the management of poor-prognosis teeth with periradicular involvement at least till 6 months if not later. Similarly, Trairatvorakul and Detsomboonrat  also observed good clinical success rate of 75% with 3Mix–MP but a low success rate in radiographic evaluation at 6 months, contradictory to previous reports. Extirpated pulp group from the study done by Prabhakar et al. showed much higher success (83.3%). Therefore, instrumentation for radicular pulp extirpation treatment may be better for further studies.
In Group 2, all the study participants remained asymptomatic till the end of 6 months. The clinical and radiological success rates were observed to be 100% and 76%, respectively. Radiographically, the mixture of ZnOE and Ca(OH)2 proved to be a satisfactory filling material as all the cases that had preoperative pathological external resorption and internal resorption did not show any evidence of progression, and there was no de novo case of pathological root resorption. Furcation and periapical radiolucencies were also well controlled with evidence of bone regeneration and reestablishment of lamina dura. No tooth was extracted in this group owing to treatment failure, which gave us slightly better results as compared to Chawla et al. who also used the mixture of Ca(OH)2 and ZnO for pulpectomy. Contrary to the present study, 2 teeth out of a total of 25 were found to be unsuccessful and were extracted in their study. Because no comprehensive in vivo study using a mixture of Ca(OH)2 and ZnO as a filling material has been reported in the literature, drawing an exact cross comparison is difficult. Nevertheless, an overall success rate of 76% achieved by pulpectomy in Group 2 study participants of our study is comparable to the success rate achieved by various authors with different filling materials. Various investigators have found the following success rates in studies carried out using ZnOE: Yacobi et al. (92% success at 6 months, 84% at 12 months), Barr et al. (82.3% success), Flaitz et al. (84% success), and Coll and Sadrian  (86.1% success). Garcia-Godoy  and Rifkin  have reported success rates of 82.85% and 95.6%, respectively, with the use of KRI paste. Nurko et al. have reported almost 100% success with the use of a Ca(OH)2-iodoform paste, but it had a tendency to resorb early from the canals. In addition, we were able to salvage teeth with relatively poor prognosis, contrary to many previous reports.
The trend that was observed in the clinical and radiological profile till 3 months was that Group 2 cases had more success when absolute numbers and figures were compared. We could not achieve statistically significant differences between Group 1 and Group 2 either clinically or radiologically at the end of 3 months. Significant differences began to appear between the two study groups when reviewed at 6 months postoperatively. The clinical success in Group 1 and Group 2 was observed as 76% and 100%, respectively. Radiological success in Group 1 and Group 2 was 44% and 76%, respectively, and the difference was found to be statistically significant. This could be attributed to the appearance of radiographic new lesions in 40% of cases of Group 1 as compared to only 10% of cases in the pulpectomy group. This difference was highly significant between the two study groups. Moreover, significant differences were also observed between the groups with respect to the improvement seen in the furcation radiolucencies. Tooth treated with LSTR also showed a statistically significant increase in furcation radiolucencies as compared to traditional endodontics.
To summarize, at the end of 1 and 3 months, both the study groups were comparable in their overall success rates. At 6 months, the clinical success was comparable between the two study groups. Radiographic success rate of the two study groups achieved statistically significant difference, with Group 2 faring better than Group 1. Furthermore, on statistically analyzing the overall success rates of each group when compared to baseline, we observed that the success rates of 44% (Group 1) and 76% (Group 2) achieved at 6 months were highly significant for the treatment we rendered to save poor-prognosis teeth. More elaborative studies with clinical and radiological evaluations with longer follow-up, preferably till the period of tooth exfoliation, are needed that will throw light on the long-term benefits of pulp therapies.
| Conclusion|| |
Primary mandibular molars showing signs of irreversible pulpitis, particularly those which were destined to have a poor prognosis, were successfully treated in Group 1 using LSTR and in Group 2 with traditional endodontics using a mixture of Ca(OH)2 and ZnO as obturating material. The overall success rate of both the study groups was comparable at 1- and 3-month reviews. At 6 months, the clinical success was comparable between the two study groups; Group 2 cases fared significantly better when assessed radiographically at the end of 6 months. The results are suggestive of the importance of LSTR in simple and conservative management of poor-prognosis teeth with periradicular involvement at least for a period of 6 months. Poor-prognosis teeth were successfully treated in Group 2, entailing the effectiveness of the mixture of Ca(OH)2 and ZnO as obturating material in traditional endodontics. Additional radiographic findings, namely bone regeneration in the previous bone loss areas and re-establishment of continuity of lamina dura, were observed to be much better with Group 2. More comprehensive studies with clinical and radiological evaluations having longer follow-up, preferably till the period of tooth exfoliation, are needed that will shed light on the long-term benefits of pulp therapies.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]