|Year : 2017 | Volume
| Issue : 4 | Page : 346-352
Comparative evaluation of clinical and radiological success of zinc oxide-ozonated oil, modified 3mix-mp antibiotic paste, and vitapex as treatment options in primary molars requiring pulpectomy: An in vivo study
Divya Doneria, Seema Thakur, Parul Singhal, Deepak Chauhan
Departments of Pedodontics, H. P. Government Dental College, Shimla, Himachal Pradesh, India
|Date of Web Publication||15-Sep-2017|
Room No 301, Department of Pedodontics, H. P. Government Dental College, Shimla, Himachal Pradesh
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objectives: The aim of this study was to evaluate the clinical and radiographic success of zinc oxide-ozonated oil (ZnO-OO), modified 3Mix antibiotic paste, and Vitapex in treatment of primary molars requiring pulpectomy. Methods: Sixty-four primary molars of forty three children aged between 4 and 8 years with pulpally involved primary molars requiring root canal procedures were treated with ZnO-OO, modified 3Mix-MP paste, and Vitapex. The subjects were followed up clinically at 1, 6, and 12 months whereas radiographically at 6 and 12 months, respectively. Results: The results showed that the clinical and radiographic success rates of ZnO-OO and Vitapex over 12 months period of observation were 100% whereas, for modified 3Mix-MP paste, the results were 95.8% and 79.2%, respectively. Conclusion: On the basis of the overall success rates of all the three medicaments, following order of performance can be inferred clinical success and radiographical success:- ZnO-OO = Vitapex > modified 3MIX-MP paste.
Keywords: Lesion sterilization and tissue repair, modified 3Mix-MP paste, primary teeth, pulpectomy, Vitapex, zinc oxide-ozonated oil
|How to cite this article:|
Doneria D, Thakur S, Singhal P, Chauhan D. Comparative evaluation of clinical and radiological success of zinc oxide-ozonated oil, modified 3mix-mp antibiotic paste, and vitapex as treatment options in primary molars requiring pulpectomy: An in vivo study. J Indian Soc Pedod Prev Dent 2017;35:346-52
|How to cite this URL:|
Doneria D, Thakur S, Singhal P, Chauhan D. Comparative evaluation of clinical and radiological success of zinc oxide-ozonated oil, modified 3mix-mp antibiotic paste, and vitapex as treatment options in primary molars requiring pulpectomy: An in vivo study. J Indian Soc Pedod Prev Dent [serial online] 2017 [cited 2019 Oct 23];35:346-52. Available from: http://www.jisppd.com/text.asp?2017/35/4/346/214925
| Introduction|| |
The primary aim of endodontic treatment in primary teeth is to remove all bacterial infections by endodontic instrumentation and proper irrigation and to obturate the root canals with a filling material that will resorb at the same rate as the primary tooth and can be eliminated rapidly, if accidentally extruded through the apex. For an ideal root canal filling material, the following properties are required: (1) Resorbability, (2) antiseptic property, (3) noninflammatory and nonirritating to the underlying permanent tooth germ, (4) radiopacity, (5) ease of insertion and removal, (6) cost effective, (7) ability to seal canal properly, (9) ability to set under wet conditions, and (10) nonstaining to the tooth.
At present, the commonly used materials for primary root canal fillings are nonreinforced zinc oxide eugenol, iodoform-based pastes, and a combination of iodoform paste and calcium hydroxide (Vitapex and Endoflas).,,, Shortcomings reported in zinc oxide eugenol such as slow resorption, irritation to periapical tissues, necrosis of bone and cementum, and alteration in the path of eruption of succedaneous teeth led to search for its substitute.,,,, In search of newer material, it was also reported that ozonated oil with zinc oxide has the potential to be used as obturating material in primary teeth. Studies showed that ozone in aqueous form shows essentially no toxicity to oral cells in vitro and has high antimicrobial power without the development of drug resistance.,,
Vitapex (Calcium hydroxide with iodoform in oily vehicle) is considered a nearly ideal root canal filling material for primary teeth with high clinical and radiographic success rates.,,, However, its faster resorption than the root of primary tooth produces a hollow area in the root canals which is popularly known as “hollow tube effect” which can act as nidus for bacteria.,
Lesion sterilization and tissue repair (LSTR) therapy is a relatively new biologic approach in the treatment of carious lesions with or without pulpal and periapical involvement using a mixture of three broad-spectrum antibiotics, namely, metronidazole, ciprofloxacin, and minocycline (3Mix).,, Modification of 3 mix using cefaclor in place of minocycline and ornidazole in place of metronidazole has better clinical results., The rationale of LSTR is that mixture of three antibiotics (3Mix) can sterilize necrotic pulps and infected root dentin of primary teeth. Repair of damaged tissues can be expected if lesions are disinfected. In the primary dentition, LSTR has shown a high rate of clinical success as a substitute for pulpectomy., However, radiographic success is questionable in long-term follow-up. In the research to find an ideal obturating material or alternate treatment option for tooth requiring pulpectomy, the present in vivo study was undertaken to evaluate and compare clinical and radiographic success of zinc oxide with ozonated oil, Vitapex, and modified 3Mix as root canal filling materials for primary tooth.
| Methods|| |
The study consisted of patients in the age group of 4–8 years, attending the Outpatient Department of Pediatric and Preventive Dentistry, Himachal Pradesh Government Dental College and Hospital, Shimla. Ethical approval from the Institutional Ethical Committee and consent from the parents/guardians were obtained. The criteria for selection of teeth were cooperative child with clinical characteristics showing one or more signs and symptoms indicating pulpectomy is required:
(a) spontaneous pain or tender to percussion, (b) deep carious with pulp exposure, (c) uncontrolled hemorrhage after removal of coronal pulp tissue, (d) presence of chronic apical abscess or sinus tract, and (e) the tooth should be restorable and radiographic characteristics: (a) coronal-radiographic evidence of a deep carious lesion or lesion approximating pulp (b) radicular- (i) discontinuity of lamina dura and (ii) Furcation involvement less than or equal to half of shortest root in vertical dimension.
The teeth were excluded when nonrestorable or presented with physiologic root resorption more than a third of its length or if they had the presence of obliteration of the root canal, excessive internal resorption, internal calcifications, perforation into the bifurcation, or any underlying dentigerous cysts. Patients with any systemic illness or with the previous history of allergy to the antibiotics used in the study were also excluded from the study.
Clinical and radiographic information before treatment was recorded by an operator. The enrollment of teeth to either group was done randomly by envelope draw method.
Proper local anesthesia was administered, using lignocaine 2% with 1:200,000 epinephrine (Becain-ADR, H. P., India). The tooth was isolated with a rubber dam. All treatments were performed by same operator.
Clinical procedure for zinc oxide ozonated oil and Vitapex
Proper access cavity was made using straight fissure bur. Pulp was removed initially with spoon excavator, and further radicular pulp was removed with fine H-file along with repeated irrigation with 1% sodium hypochlorite and saline. The root length was determined using diagnostic radiograph. The biomechanical preparation was done using H-files (21 mm) in pull back motion. Simultaneously, irrigation was done using 1% sodium hypochlorite and normal saline. Each canal was enlarged to two or three instrument size greater than the first file used. After drying the pulp cavity using cotton pellets and paper points, Vitapex (Neo dental co., Tokyo, Japan), which is supplied in a prepacked polypropylene syringe, was transported directly to the canals. While for zinc oxide-ozonated oil (ZnO-OO), the root canals were filled with the freshly mixed zinc oxide powder (DPI, Mumbai, India) (0.2 g, arsenic free) and ozonated castor oil (0.007 cc Ozonil, Ozone Forum of India, Mumbai, India) using motor-driven lentulospirals. After obturation of the root canals, the cavity was filled with glass ionomer cement (GIC) in same visit. The patient recalled after 15 days and final restoration was done with stainless steel crowns using standard technique.
Clinical procedure for 3Mix MP paste
Preparation of modified 3Mix MP paste
The chemotherapeutic agents used were Ornidazole tablets 500 mg (Ornida, Aristo pharmaceuticals, India), Ciprofloxacin tablets 500 mg (Ciplox ®, Alchemist Ltd., India), and Cefaclor tablets 250 mg (Distaclor ™ DT, Baroque pharmaceuticals, India). After the removal of enteric coating of tablets with the help of B.P.(Bard Parker blade), the drugs are pulverized into fine powder using sterilized mortar pestle. The powered drugs were kept separately in amber-colored airtight containers. The fine powder was used up within a month. 3Mix-MP paste was freshly prepared for each use. The same amount of each powdered drug (1:1:1) was mixed to form modified 3Mix powder. One part of propylene glycol (P) and the same volume of macrogol (M) were mixed to make MP. For standard preparation, one part of MP and seven parts of modified 3Mix powder were mixed.
Placement of modified 3 mix-MP in cavity
After chamber access with a straight fissure bur, necrotic pulp tissue was removed using a sterile sharp spoon excavator, and accessible radicular pulp was also extirpated and irrigation with 1% sodium hypochlorite was done. The canal orifices were enlarged using round bur to form medication cavity. Modified 3Mix-MP was then placed into medication cavity [as shown in [Figure 6]. After the placement of modified 3Mix-MP paste, the cavity was filled with GIC restoration in same visit and final restoration was done with stainless steel crown.
|Figure 6: Lesion sterilization and tissue repair for deciduous teeth (a) Deciduous teeth with physiologic root resorption (b) the succedaneous permanent teeth (1 and 2) final restoration by GIC (3) 3 Mix-MP in the prepared medication cavity ( 1 mm diameter and 2 mm depth)|
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Clinical and radiographic evaluation
After treatment, clinical evaluation was done at 1, 6, and 12 months while radiographic evaluations were performed at 6 and 12 months. The preoperative and follow-up radiographs are shown in [Figure 1],[Figure 2],[Figure 3] for the three groups. Blinded clinical evaluations were performed by the operator. The radiographic evaluations were carried out by two coinvestigators. The intra- and inter-examiner reliability of the first and the second coinvestigators was calculated by Cohen's kappa statistic, i.e., 0.90 and 0.867, respectively, which indicates excellent level of agreement. The criteria for clinical success were absence of pain, presence of healthy soft tissue, and absence of abnormal mobility. The criteria for radiographic success were reduction in size of interradicular radiolucency, evidence of bone regeneration/continuity of lamina dura, and absence of internal/external resorption. The treatment was judged to be successful when both clinical and radiographic criteria were fulfilled. The success rate of all three groups at 6 and 12 months was determined by statistical analysis with a Z-test for the proportion of the groups. P < 0.05 was considered statistically significant.
|Figure 1: (a) Preoperative, (b) postoperative, (c) at 6 months, (d) at 12 months; 75 treated with zinc oxide with ozonated oil as obturating material after pulpectomy (radiographic success)|
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|Figure 2: (a) Preoperative, (b) postoperative, (c) at 6 months, (d) at 12 months; 54 treated with modified 3Mix-MP paste (lesion sterilization and tissue repair therapy) (radiographic success)|
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|Figure 3: (a) Preoperative, (b) postoperative, (c) at 6 months, (d) at 12 months; 75 treated with Vitapex as obturating material after pulpectomy (radiographic success)|
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| Results|| |
Distribution of tooth type in the sample is shown in [Table 1]. Before treatment, the majority of the teeth in three groups presented with pain or tenderness to percussion. Pre- and post-operative and follow-up clinical examinations at 1, 6, and 12 months are shown in [Table 2]. Radiological evaluation at pre- and post-operative at 6 and 12 months are shown in [Table 3].
|Table 1: Distribution of study sample according to tooth type treated in three groups|
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|Table 2: Clinical evaluation preoperative and postoperative at 1, 6, and 12 months|
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Postoperative clinical findings
All teeth of three groups were clinically checked at 1 month postoperatively. At this time, no pain, abscess, and mobility were reported but nine teeth showed pain on percussion among total 64 treated teeth. At 6 and 12 months, ZnO-OO, and Vitapex groups showed 100% clinical success whereas modified 3 mix-MP paste (LSTR therapy) showed 95.5% of clinical success. All cases revealed excellent clinical signs of success with the absence of any pain or sensitivity or signs of mobility, fistula, swelling, or inflammation of the gingival tissue surrounding the tooth after the treatment except one tooth which presented with symptoms of pain, abscess, and mobility in modified 3 mix-MP paste at 6 months. Retreatment was done for this tooth and symptoms subsided, but at 12 months, this tooth presented with abscess and mobility. The clinical success for three groups had no statistically significant difference was found between the three groups at the end of 6 months [Graph 1].
Postoperative radiological findings
In ZnO-OO and Vitapex groups, the radiological success was 100% at 6 and 12 months whereas modified 3 mix-MP paste showed 83.5% and 79.2% of radiological success at 6 and 12 months. Considering the radiographic findings at the end of 6 and 12 months, statistically significant differences were found between three groups (P = 0.029 and 0.011, respectively) [Graph 1] and [Graph 2]. More specifically, internal resorption was observed in three of the teeth treated with modified 3Mix-MP paste at 6-month recall [Figure 4]. Among these three reported failures, two teeth showed internal resorption which confined to the tooth and did not show any clinical symptoms which showed no further increase in the resorption area at 12 months. One tooth showed internal resorption, increase in interradicular radiolucency [Figure 5], and also presented with clinical symptoms of abscess and mobility.
|Figure 5: 85 showing increase in interradicular radiolucency at 12 months|
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| Discussion|| |
This study examined the clinical and radiographic success rate of ZnO-OO and modified 3Mix-MP paste for root canal treatment of pulpally involved primary molars compared with widely used materials such as Vitapex. In search of newer material, researchers drew attention toward ozone as it has potent antimicrobial action and is biocompatible for oral cells. Ozonated water and olive oil have the capacity to entrap and then release oxygen/ozone, an ideal delivery system. In reaction to oils, ozone breaks the double bonds between carbon atoms of lipid molecules, producing oxygenated compounds such as hydroperoxides and polyperoxides which accounts for its action. In endodontics, few studies have focused on the use of ozone as an intracanal medicament and as an irrigant.,,
The search of dental literature showed only one published study by Chandra et al. (2014), in which zinc oxide with ozonated oil was evaluated as filling materials for root canal treatment in primary teeth. In our study, zinc oxide and ozonated oil mixture was used as obturating material in one group. The clinical success rate of 100% at 6 and 12 months in our study is in accordance with Chandra et al. (2014). The radiological success rate of 100% in our study at 6 and 12 months is slightly more than that reported by Chandra et al., i.e., 96.7% and 93.3%, at 6 and 12 months, respectively.
In the present study, Vitapex was used for obturation in primary molars. The overall clinical and radiological success rate at 12 months is 100%, which was in accordance with and comparable with the studies reported by Ozalp et al., Trairatvorakul and Detsomboonrat et al. Mortazavi and Mesbahi, (2008) Nakornchai et al., and Pramila et al. in the literature. However, the radiological success rate that was reported by Nakornchai et al., i.e., 56% was very less which can be due to poor prognosis sample selected in their study.
Due to several anatomic complications, long-term successful outcome of conventional pulpectomy procedure in necrotic or abscessed primary teeth has been reported in literature up to 85%., Hence, the use of such procedure should have a convenient alternative with comparable or better success rate. The Cariology Research Unit of the School of Dentistry, Niigata University, Niigata, Niigata Prefecture, Japan, developed the concept of LSTR therapy in 1990. Extensive in vitro and in situ studies have shown that the mixture (3-Mix) of metronidazole, ciprofloxacin, and minocycline is effective against oral bacteria including those in the endodontic lesions of primary teeth.,, Cruz et al. showed that the addition of propylene glycol and macrogol (MP) as a carrier vehicle greatly improved the penetration ability of these medications.
Newer drug combinations were also used by replacing minocycline with drugs having same antibacterial spectrum, for example, amoxicillin, cefaclor, cefroxadine, fosfomycin or roxithromycin,, clindamycin, and metronidazole with ornidazole  and tinidazole. We also modified 3Mix-MP mixture by substituting metronidazole and minocycline, ornidazole, and cefaclor, respectively, with macrogol and propylene glycol as vehicle. In our study, modified 3Mix-MP paste was used and one clinical failure was observed at 6 months evaluation and 4 failures were observed radiologically. Furthermore, at 12 months, there was one clinical failure and five radiological failures noted on evaluation. The overall clinical success rate at 12 months is 95.8%, which was in accordance and comparable with Prabhakar et al. and Pinky et al. Prabhakar et al. compared pulpotomy and pulpectomy techniques in LSTR in Group A and Group B, respectively, and reported 93.3% clinical success rate for Group A whereas 100% for Group B. Pinky et al. compared 3Mix and modified 3Mix in Group 1 and Group 2, respectively, and reported clinical success rates of 90% and 100%, respectively. The radiological success rate of 79.2% is comparable with Nakornchai et al. However, it is lesser than as reported by Prabhakar et al. and Pinky et al. but higher than that of Agarwal et al. and Trairatvorakul et al. Studies reported earlier on LSTR in primary teeth showed variation in success rates due to differences in sample selection, evaluation criteria, and techniques employed for LSTR.
In our study, internal resorption and increase in intraradicular radiolucency were found to be the most common cause of radiologic failure in LSTR group with modified 3Mix antibiotic paste. Previous investigations have also reported increase in radiolucency and internal resorption as the most frequent postoperative radiological failures observed in primary molars after LSTR.,, Trairatvorakul and Chunlasikaiwanreported the overall success rates for conventional pulpectomy were higher (89%) than the overall success rates of 3Mix-MP noninstrumental endodontic treatment (36.7%). However, results with 3Mix-MP with radicular pulp extirpation yielded comparable success (83.3%) which are in accordance with our study.
Within the three groups, the clinical success of ZnO-OO group and Vitapex group were comparable at 6 and 12 months, i.e., 100%, whereas for LSTR group, it was 95.8% which was slightly lesser with statistically no significant difference (P < 0.429). Radiologically, success rates for ZnO-OO group and Vitapex group were 100% at 6 and 12 months. However, in LSTR group, the success rates were 83.3% and 79.2% at 6 and 12 months, respectively. These results were statistically significant (P < 0.011).
In the present study, although all three materials have shown clinically good results, yet further studies with a larger sample size with a longer period of follow-up is required. Investigations are also required to understand the reaction of periapical tissues to drugs as well as the amount of drug absorption into the systemic circulation. Ultrastructural, histological, and microleakage studies may be helpful to further determine the suitability of ZnO-OO in future pulpectomy studies.
| Conclusion|| |
Within the limits of the present in vivo study, we conclude that all three materials used in ZnO-OO, modified 3Mix-MP, and Vitapex can be used effectively as pulpectomy agents in deciduous teeth. It can also conclude that ZnO-OO can be safely and successfully used as a new obturating material in primary teeth and modified 3Mix-MP antibiotic treatment can be a substitute of conventional root canal treatment in primary molars.
Financial support and sponsorship
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]