|Year : 2016 | Volume
| Issue : 4 | Page : 383-390
Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial
Sneha Bharatkumar Bharuka, Praveenkumar S Mandroli
Department of Pedodontics and Preventive Dentistry, Maratha Mandal's Nathajirao G. Halgekar Institute of Dental Sciences and Research Centre, Belgaum, Karnataka, India
|Date of Web Publication||29-Sep-2016|
Praveenkumar S Mandroli
Department of Pedodontics and Preventive Dentistry, Maratha Mandal's Nathajirao G. Halgekar Institute of Dental Sciences and Research Centre, Bauxite Road, Belgaum - 590 010, Karnataka
Source of Support: None, Conflict of Interest: None
Clinical trial registration CTRI/2014/01/004333
| Abstract|| |
Context: Reduction of the bacterial populations to levels compatible with periradicular tissue healing is the primary microbiological goal of the endodontic treatment of teeth with apical periodontitis. The number of visits required to treat teeth with apical periodontitis represents one of the most debatable issues in endodontics. Objectives: The objective of this study was to compare and evaluate the clinical and radiographic outcome of single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis at the end of 6-month healing period. Settings and Design: A parallel group, double-blind, randomized controlled trial was carried out in 64 children aged 4-8 years. Nonvital primary teeth with apical periodontitis with enough coronal structure were selected. Sixty-four children were assigned randomly into two groups (32 children each) by block randomization, and allocation concealment was done with closed envelop method. Methods and Materials: Group I underwent single-visit pulpectomy followed by obturation with zinc oxide eugenol (ZOE). Group II underwent conventional two-visit pulpectomy with intracanal calcium hydroxide, followed by obturation with ZOE. Postoperative clinical and radiographic evaluation was carried out at 1, 3, and 6 months after the end of the treatment. Statistical Analysis Used: The data were analyzed by Wilcoxon's signed rank test, Mann-Whitney U-test, and Friedman test. Results: There was no statistically significant difference in clinical and radiographic outcomes in both the groups at the end of 6-month healing period. Conclusion: Single-visit pulpectomy can be considered as a viable option for the treatment of primary teeth with apical periodontitis.
Keywords: Apical periodontitis, single-visit pulpectomy, two-visit pulpectomy
|How to cite this article:|
Bharuka SB, Mandroli PS. Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial. J Indian Soc Pedod Prev Dent 2016;34:383-90
|How to cite this URL:|
Bharuka SB, Mandroli PS. Single- versus two-visit pulpectomy treatment in primary teeth with apical periodontitis: A double-blind, parallel group, randomized controlled trial. J Indian Soc Pedod Prev Dent [serial online] 2016 [cited 2021 May 13];34:383-90. Available from: https://www.jisppd.com/text.asp?2016/34/4/383/191429
| Introduction|| |
Pulpectomy is a root canal procedure for pulp tissue that is irreversibly infected or necrotic due to caries or trauma. A pulpectomy is indicated in a primary tooth with irreversible pulpitis or necrosis or a tooth treatment planned for pulpotomy in which the radicular pulp exhibits clinical signs of irreversible pulpitis (eg, excessive hemorrhage that is not controlled with a damp cotton pellet applied for several minutes) or pulp necrosis (eg, suppuration, purulence). 
Apical periodontitis is inflammation and destruction of periradicular tissues caused by etiological agents of endodontic origin. It is viewed as a dynamic encounter between microbial factors and host defenses at the interface between infected radicular pulp and periodontal ligament that results in local inflammation, resorption of hard tissues, destruction of other periapical tissues, and eventual formation of various histopathological categories of apical periodontitis, commonly referred to as periapical lesions.  The treatment of apical periodontitis consists of eliminating microbes or significantly reducing the microbial load from the root and preventing re-infection by sealing the root canal space. Whether adequate microbial control can be obtained in single appointment is an ongoing debate.
Treatment in single visit certainly has many advantages. It is less time-consuming, resulting in less cost for the patient. In addition, various studies have shown that postoperative pain is equally low when the treatment is performed in single or multiple visits. In fact, an argument could be made that added discomfort due to local anesthetic or trauma from a rubber dam application experienced after a second visit makes single-visit endodontic treatment less painful than multi-visit treatment. With the apparent advantages of single-visit endodontic treatment, it is not surprising that this treatment mode has become pertinent. 
Although there are many reported studies comparing the outcome of single- versus two-visit root canal treatment in permanent teeth with apical periodontitis, there are no reported studies for nonvital primary teeth with apical periodontitis. The purpose of this randomized controlled trial was to compare the outcome of single- versus two-visit pulpectomy treatment in teeth with apical periodontitis at the end of 6-month healing period.
| Materials and Methods|| |
The present parallel group, double-blind, randomized controlled trial was carried out in the Department of Pedodontics and Preventive Dentistry of the institute. Sixty-four children aged 4-8 years with enough coronal structure were selected. Sixty-four children were assigned randomly into two groups (32 children each) by block randomization, and allocation concealment was done with closed envelop method. The trial was approved by the Institutional Review Board and was registered prospectively with Clinical Trial Registry of India (CTRI Registration No. CTRI/2014/01/004333). Informed, written assent for treatment from the children and consent from the parents/guardians were obtained prior to clinical procedures.
The inclusion criteria were as follows:
- Healthy co-operative children in the age group of 4-8 years, who had at least one primary tooth indicated for pulpectomy irrespective of sex, race, or socioeconomic status
- Primary teeth with nonvital pulps and apical periodontitis with enough coronal tooth structure, after clinical and radiographic confirmation.
The exclusion criteria were as follows:
- Patients with underlying systemic conditions and special health-care needs
- Patients giving a positive history of antibiotic use within the past month.
A detailed history related to pain was recorded. A full-mouth examination was carried out along with standardized periapical radiographs for any teeth with possible indication of pulpectomy before the start of the clinical study. Parallel cone technique with standard exposure was used to obtain accurate radiographs. Randomization, enrollment, and assignment of participants to interventions were done by specialist pedodontist not involved in the study.
All treatments were carried out by a single operator (SBB). After confirming the diagnosis, anesthesia was achieved by administering 2% lidocaine with 1:80,000 epinephrine (Xicaine® , ICPA Health Products, India). The tooth was isolated using a rubber dam (Hygienic® , Coltene/Whaledent Inc., USA).
All superficial caries were removed with round tungsten carbide bur, and roof of the pulp chamber was removed with sterile diamond burs in a high-speed handpiece. The exposed inflamed coronal pulp/necrosed tissue was amputated using a spoon excavator and irrigated with saline. Then, the necrosed tissue was carefully extirpated from the root canals using 15 size H file. The working length was established by a radiograph and confirmed using an iPex Apex Locator (NSK, Japan). Endodontic files were selected and adjusted to stop 1 or 2 mm short of the radiographic apex of each canal. After extirpation of pulp, canals were debrided thoroughly with precurved 15 size H file using a pullback action and then sequentially increasing up to the size of 30. The canals were carefully irrigated with 1% sodium hypochlorite (NaOCl) solution with no excessive pressure. Sterile saline was used as an alternating irrigant.
- For the single-visit group (Group I-experimental), the canals were dried with sterile paper points and obturated at the same appointment with chemically pure zinc oxide eugenol (ZOE) (Dental Products of India® , Mumbai, Maharashtra, India). The paste of ZOE was deposited in the canals with lentulospirals while taking out slowly followed by subsequent increments till the complete filling of the canals was achieved. The orifices of canals were sealed with a thicker mix of ZOE. Access cavities were restored with Resin-modified glass ionomer Cement (GC Corp., Tokyo, Japan), and a stainless steel crown was placed (3M ESPE Dental Products, St. Paul, Minnesota, USA)
- For the two-visit group (Group II-control), the canals were dried, and a mix of calcium hydroxide (Ca(OH) 2 ) powder (DentPro, India) and saline was placed. The access cavities were sealed with ZOE temporary restoration. After 2-3 days, Ca(OH) 2 was removed with manual files and irrigated carefully with 1% NaOCl alternating with saline. The canals were dried with sterile paper points and obturation was performed with the same technique described for the single-visit group. Access cavities were restored with Resin-modified glass ionomer Cement, and a stainless steel crown was placed.
After the placement of crown, immediate postoperative radiographs were taken for future review. Periodic follow-up examinations were carried out at 1, 3, and 6 months after the end of the treatment. Each checkup involved a clinical and radiographic examination [Figure 1] and [Figure 2] of the pulpectomized teeth and their periradicular area, according to the criteria laid down by Gutmann JL  by two trained precalibrated examiners who were blind to the procedure [Figure 3].
|Figure 1: Radiographic outcome of single-visit pulpectomy treatment at (a) preoperative, (b) 1-month follow-up, (c) 3-month follow-up, and (d) 6-month follow-up|
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|Figure 2: Radiographic outcome of two-visit pulpectomy treatment at (a) preoperative, (b) 1-month follow-up, (c) 3-month follow-up, and (d) 6-month follow-up|
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| Results|| |
The distribution of the study sample [Figure 4] is shown in [Table 1]. With respect to clinical progression [Table 2], there was a statistically significant difference between immediate postoperative and 1-month follow-up mean scores (P < 0.001), but there was no difference in the scores between 1-3 months and 3-6 months in both the groups. With respect to radiographic progression [Table 3], there was no significant change when immediate and 1 month's scores were compared. However, a statistically significant change in scores occurred during 1-3 months and 3-6 months (P < 0.001). The scores indicate a sequential radiographic success seen in both the groups (Wilcoxon signed rank test).
|Figure 4: Flow diagram showing the progress of the phases of the trial up to 6 months|
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|Table 2: Progression of clinical outcome of single - and two - visit groups at immediate, 1 - , 3 - , and 6 - month intervals|
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|Table 3: Progression of radiographic outcome of single - and two - visit groups at immediate, 1 - , 3 - , and 6 - month intervals|
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Interval-wise comparison of the mean scores for clinical outcome of both the groups [Table 4] and [Figure 5],[Figure 6] showed no statistically significant difference at immediate postoperative and at the end of 1-, 3-, and 6-month follow-up periods. On interval-wise comparison of radiographic outcome [Table 4] and [Figure 6], there was a statistically significant difference at immediate postoperative (P = 0.002) and at the end of 1 month (P = 0.003). The comparison at 3 months and 6 months showed no statistically significant difference between both the groups (Mann-Whitney U-test).
|Figure 5: Bar diagram showing comparison of mean scores of clinical outcome of single-and two-visit pulpectomy groups at different time points|
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|Figure 6: Bar diagram showing comparison of mean scores of radiographic outcome of single-and two-visit pulpectomy groups at different time points|
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According to the Cohen kappa statistical analysis, overall values showed a good agreement between the two examiners for radiographic interpretation. Statistical Package for Social Sciences software was used for the analysis of the data (SPSS for Windows, version 10.0. SPSS Inc., Chicago, IL, USA). P < 0.05 was considered statistically significant for all comparisons.
|Table 4: Comparison of clinical and radiographic outcome of single - and two - visit groups at immediate, 1 - , 3 - , and 6 - month intervals using Mann-Whitney U - test|
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| Discussion|| |
The number of visits required to treat the root canals of teeth with apical periodontitis represents one of the most debatable issues in endodontics. No statistically significant difference in the clinical or radiographic success rates was observed between the single- and two-visit groups, at 1-, 3-, and 6-month intervals. There are many published studies comparing the outcomes of single- versus two-visit endodontic treatment in permanent teeth with apical periodontitis. However, there were no similar studies reported for primary teeth. Our results corroborate with the results of the similar previous studies carried out on permanent teeth. ,,,,,,
Clinical outcome of single- and two-visit pulpectomy
Both groups showed comparable effects in terms of clinical recovery at all the time intervals studied, i.e. immediate, 1-, 3-, and 6-month intervals. Both the groups showed a statistically significant difference (P < 0.001) between immediate postoperative scores and 1-month follow-up, but there was no difference in the scores between 1-, 3-, and 6-month follow-up [Table 2]. This indicates that clinical outcome was progressing from "failure" to "questionable" to "success." In addition, interval-wise comparison of the mean scores of clinical outcome of both the groups showed no statistically significant difference at immediate postoperative and at the end of 1-, 3-, and 6-month follow-up periods [Table 4].
Principally, bacteria in the root canal space are responsible for apical periodontitis. Therefore, the aim of a rational treatment is to eliminate as many of these bacteria as possible. The accepted procedure for the best results in canal disinfection is based on complete debridement and irrigation of the root canal during the first appointment, followed by the application of a Ca(OH) 2 dressing for 2-3 days. Root filling is then completed at the second or a later appointment. Mechanical instrumentation alone causes a 100- to a 1000-fold decline in the number of bacteria, but complete eradication can be seen in only 20%-43% of the cases. Added antibacterial irrigation with NaOCl alternating with saline results in disinfection in some 40%-60% of the teeth thus treated. The subsequent application of a Ca(OH) 2 dressing brings the percentage of bacteria-negative teeth to 90%-100%; this treatment regimen is thus the contemporary model for root canal disinfection. 
One issue debated in recent years is whether meticulous cleaning by instrumentation and irrigation may reduce the need for a dressing and effective satisfactory disinfection of the canal system. In a systematic review regarding the biological aspects of one-appointment endodontic therapy for asymptomatic teeth with apical periodontitis, mechanical instrumentation with repeated irrigation with copious amounts of an antimicrobial agent was found to be the most efficient way to lessen the intracanal bacterial level. 
Intracanal medication is extensively used in attempts to kill any residual bacteria after instrumentation and irrigation. There is a growing amount of evidence that questions the usefulness of Ca(OH) 2 to eliminate microorganisms entirely from the root canals. , In a systematic review, Ca(OH) 2 was shown to have inadequate effectiveness in eliminating bacteria from human root canal by means of culture techniques.  Because of the complexity of the root canal anatomy (such as lateral/accessory canals, apical ramifications, isthmuses, and fins), complete root canal disinfection may not be possible to accomplish in primary teeth with apical periodontitis regardless of the number of dental visits. The comparison of mean postoperative pain scores showed no statistically significant difference at immediate postoperative and at the end of 1-, 3-, and 6-month follow-up periods for single- and two-visit groups. Our results confirm with the several other studies on permanent teeth comparing postoperative pain and flare-ups in the two groups. ,,,,,,,,,,
It should also be noted that the outcomes of endodontic treatment might be influenced by several factors such as clinical approaches, skill and experience of operators and evaluators, location and size of periapical lesion, and follow-up periods. In this study, the clinical outcome of single-visit group was comparable to two-visit group during all the follow-up visits. There could be several possible reasons for this. (1) use of rubber dam for isolation, which unquestionably must have prevented contamination of root canals by oral bacteria, (2) single operator performed treatment for all the children, resulting in uniform standard care, (3) the root canals were thoroughly and carefully debrided by a sequential use of endodontic instruments. The sterile endodontic files were precurved for easier negotiation of the canal curvatures. Furthermore, filing was first completed in the coronal half, followed by the apical half of the root canal to prevent transportation of debris into the periapical area, (4) the canals were filed to a minimum size of no. 30, allowing the maximum removal of bacteria trapped in the pulpal wall of dentin and helping intracanal irrigating solutions to reach the apical area more effectively leading to thorough chemo-mechanical debridement, (5) the irrigating solutions were handled carefully to minimize periapical tissue irritation. NaOCl, which is a known tissue irritant, was carefully deposited over the orifice of root canals during instrumentation. This certainly must have minimized the pushing of NaOCl into the periapical tissues preventing the irritation of periapical tissues, (6) and a permanent restoration of resin-modified glass ionomer cement followed by a stainless steel crown was placed in the same appointment as that of obturation to minimize the chances of coronal microleakage and re-infection.
Radiographic outcome of single- and two-visit pulpectomy
The degree of apical healing determines whether a certain mode of pulpectomy is considered appropriate. Analysis of the overall change in scores across 6 months showed a significant improvement in radiographic scores across the time period for both single- and two-visit groups, indicating a comparable success [Table 3]. The individual comparison of scores between each time period showed that for single-as well as two-visit groups, there was no significant change in radiographic scores when immediate and 1 month's scores were compared, indicating that radiographic healing was "questionable." A significant change in radiographic scores occurred during 1-3 months and 3-6 months, i.e., there was a gradual change from "questionable" to "success." With respect to the interval-wise comparison of radiographic outcomes of the two groups, on immediate measurement, the single-visit group had significantly higher scores compared to the two-visit group, and the difference remained so even after 1 month. However, at 3 and 6 months, the radiographic scores did not differ significantly [Table 4].
To preclude bias, all radiographic films obtained preoperatively and at follow-up were coded blind and organized in a random order. Two precalibrated trained pedodontists (authors not included) independently evaluated all radiographs under moderate illumination at a light table using a magnifying viewer equipped with a masking frame, the same size as the dental film. Before evaluation of the study images, each examiner graded a series of 15 radiographic images not associated with the study sample and representing a wide range of periapical bone densities.
Several limitations of this study may be noted. (1) length of observation period - the length of the observation period subsequent to the completion of an endodontic treatment procedure is important for valid conclusions. The present study along with several other studies in the literature included cases observed for 6 months. Such short observation periods may not reflect the long-term outcome of the therapy, although the probability of the emergence of a lesion beyond the 1-year follow-up is not likely to be high.  (2) ZOE is one of the most widely used preparations for primary tooth pulpectomies. When the erupting permanent successor meets root filling material, there is a possibility of delayed resorption or deflection of erupting tooth, but this is most unlikely if pure zinc oxide has been used.  In the present study, patients in the age group of 4-8 years were selected. Root formation of primary molars is completed by 3 years of age and root resorption begins only by 6 years of age.  The un-resorbed roots at the time of treatment would have certainly improved the quality of obturation and also must have reduced the chances of extrusion of obturating material.
A one-visit root canal treatment is attractive to the parent because it saves time and would probably reduce the cost of treatment. In addition, one-visit treatment would be expected to be less stressful to the anxious child. The child is not distressed by the additional anesthetic injections, the replacement of the rubber dam, the initial placement and later removal of intracanal medication and seals, and the time spent by the clinician in refreshing his/her memory, tactile sensation about prepared canal anatomy, tooth length, etc., The most important advantage is the prevention of root canal contamination and/or bacterial re-growth that can occur when the treatment is prolonged over an extended period. 
More randomized controlled clinical trials using longer observation periods are required to establish an evidence-based decision regarding one-appointment endodontic therapy for primary teeth with apical periodontitis. It would be interesting to see the outcome with more biocompatible obturating materials for primary teeth.
| Conclusion|| |
The choice of deciding whether single- or two-visit pulpectomy should be based on aspects related both to the clinical feasibility of the method and its biological outcomes. Based on available evidence, it seems reasonable to conclude that single-visit pulpectomy for teeth with apical periodontitis, if carried out under stringent and controlled conditions, may result in a very high success rate. Reports in the literature also conclude that the number of appointments is not a significant factor and that instrumentation and root filling can be completed in one sitting without jeopardizing the long-term success. Single-visit pulpectomy can be considered as a viable option for the treatment of primary teeth with apical periodontitis.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
[Table 1], [Table 2], [Table 3], [Table 4]