Year : 2010 | Volume
: 28 | Issue : 1 | Page : 25--29
Clinical and radiographic evaluation of pulpectomies using three root canal filling materials: An in-vivo study
K Ramar1, J Mungara2,
1 Lecturer, Department of Pedodontics and Preventive Dentistry, SRM Dental College, Chennai, India
2 Professor and Head, Department of Pedodontics and Preventive Dentistry, Ragas Dental College, Chennai, India
Department of Pedodontic and Preventive Dentistry, SRM Dental College, Ramapuram, Chennai
Various root canal filling materials are used to preserve a pulpally involved carious primary tooth. But there is no single material so far available to fulfill all the requirements of an ideal root canal filling material for a primary tooth. Hence this study was undertaken to evaluate clinically and radiographically the efficacy of three obturating materials - Calcium hydroxide with Iodoform (METAPEX), Zinc Oxide Eugenol with Iodoform (RC FILL) and Zinc Oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS) for a period of 9 months. Results show ENDOFLAS gave an overall success rate of 95.1%, METAPEX - 90.5% and RC FILL - 84.7%. In our study, we conclude that ENDOFLAS, a mixture of Zinc Oxide Eugenol and Calcium hydroxide with Iodoform fulfills most of the required properties of an ideal root canal filling for primary teeth.
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Ramar K, Mungara J. Clinical and radiographic evaluation of pulpectomies using three root canal filling materials: An in-vivo study.J Indian Soc Pedod Prev Dent 2010;28:25-29
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Ramar K, Mungara J. Clinical and radiographic evaluation of pulpectomies using three root canal filling materials: An in-vivo study. J Indian Soc Pedod Prev Dent [serial online] 2010 [cited 2021 Jul 28 ];28:25-29
Available from: https://www.jisppd.com/text.asp?2010/28/1/25/60481
Pulpectomy helps in preserving a pulpally involved primary tooth by eliminating bacteria and their products and ensures hermetic seal of the root canals so that the primary teeth can complete its function until normal exfoliation can occur without harming the successor or affecting the health of the patient. 
An ideal root canal filling material must possess the necessary properties of being antibacterial, resorbable at the same rate of the root and harmless to periapical tissues and the developing tooth bud. In addition, it must easily fill the canals, adhere to the walls, not shrink, must readily resorb if passed beyond the apex, be easily removed if necessary, be radiopaque and causes no discoloration of the tooth. At present there is no such ideal material to meet all the requirements. ,,
Since 1930s, zinc oxide Eugenol has been the material of choice, but it has certain disadvantages like slow resorption,  irritation to periapical tissues,  necrosis of bone and cementum  and alters the path of eruption of succedaneous tooth.  Thus Zinc Oxide Eugenol either alone or with a fixative like formocresol or Iodoform gave a success rate of 65-86%. , The use of calcium hydroxide in permanent teeth has been well documented. Two isolated case reports found it was highly successful in primary teeth.  Calcium hydroxide being antibacterial, resorbable and biocompatible  can also be used in primary teeth. Iodoform was found to have excellent healing properties with resorption of the excess material giving a success rate of 84-100%.  Dominguez et al, reported that when combining Iodoform and Calcium Hydroxide, it gave a success rate of 100%. , But the main disadvantage was intra-radicular resorption of the material. [16,17] A mixture of Calcium Hydroxide, Zinc Oxide Eugenol and Iodoform gave a success rate of 83% with good healing and resorptive capabilities and was said to be a good alternative to the traditionally used materials. 
The main purpose of the study was to evaluate the clinical and radiographic efficiency of three obturating materials - Zinc oxide Eugenol with Iodoform (RC Fill), Calcium hydroxide with Iodoform (METAPEX), Zinc oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS), for a period of 3, 6 and 9 months.
Materials and Methods
A total of 96 carious primary mandibular molars, showing signs of pulpal/periapical/interradicular radiolucency with no pathologic mobility were selected from 77 children in the age group of 4-7 years. They were free of any systemic disease, and attended the Department of Pedodontics and Preventive Dentistry, Ragas Dental College and Hospital, Chennai. After obtaining consent from their parent or guardian, they were randomly selected and divided into three groups GI, GII and GIII. Clinical and radiographic evaluation was done to exclude teeth showing internal or pathologic root resorption and (or) inadequate bone support. The selected teeth were alternatively treated with Zinc Oxide Eugenol with Iodoform (RC FILL) as Group I, Calcium hydroxide with Iodoform (METAPEX) as Group II and Zinc Oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS) as Group III, respectively [Table 1].
Under local anesthesia the clinical procedure was performed in a single sitting manner. Uncooperative patients were desensitized in the first visit and the procedure was done in the next visit. A surgically clean technique was maintained throughout the procedure under rubber dam isolation. Caries was completely removed and any overhanging enamel planed to provide good access to coronal pulp. Access opening was done with a slow speed No. 4 or No. 6 carbide bur with copious water supply. All overhanging dentin was removed from the roof of the pulp chamber. The coronal pulp was amputated with a sharp spoon excavator, large enough to extend across the entrance of the individual root canals. Barbed broaches were used to remove the pulpal debris. Fine reamers were gently inserted into the canals and a diagnostic radiograph was taken to establish the length of the root canals. The working length was maintained at 1 mm short of apex while preparing the canals with Hoedstrom files (H-files) (30-35 size) used in a pull-back motion. The root canals were periodically irrigated to remove debris. A mixture of 2.25% sodium hypochlorite solution (1.5 ml) and 0.12% chlorhexidine gluconate (1.5 ml) was used as the irrigant. Care was taken to file selectively along the outer walls of the canals, as the walls towards the interradicular areas tend to be thin, with an associated risk of perforation. The canal was dried using appropriate sized paper points, the size of the last used H-file. The root canals were then filled with Zinc Oxide Eugenol with Iodoform (RC FILL) or Calcium hydroxide with Iodoform (METAPEX) or Zinc Oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS). Calcium hydroxide with Iodoform (METAPEX) was available in preformed syringes, which was directly placed into the canals and the material was extruded by simple pressure. The syringe was inserted into the canals near the apex. The paste was pressed down into the canals, and when the paste flowed back from the canal into the pulp chamber the syringe was then slowly withdrawn. Zinc Oxide Eugenol with Iodoform (RC FILL) or Zinc Oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS) was available in a powder liquid form, which was made into a medium consistency mix that formed a 1 cm string when lifted from the glass slab with the help of a cement spatula. The root canal filling was done with low-speed air motor driven lentulospirals up to the pre-determined working length. The access cavity was filled with a fast setting Zinc Oxide Eugenol paste. The crown was then prepared for receiving a preformed Stainless Steel crowns (Ion Ni-Cr, 3M Unitek, St. Paul, MN, USA) and luted with GIC Type I cement. The radiographic assessment for quality and extent of filling was made. The teeth were evaluated every 3 months for a period of 9 months, using various clinical and radiographic criteria and the findings were crosschecked by another examiner.
Criteria for clinical evaluation at 3, 6 and 9 months
Presence or absence of Pain, Redness, Swelling or abscess, Draining fistula, Mobility, Any remarkable soft tissue changes.
Criteria for radiographic findings at 3, 6 and 9 months
Presence or absence of Furcation radiolucency, Abnormal root resorption, Internal root resorption, External root resorption, Calcific metamorphosis, Deviated eruption of succedaneous teeth, Excess filling material and its resorption.
The clinical and radiographic findings at review appointments were tabulated and subject to statistical evaluation (Chi-square test).
A total of 93 mandibular primary molars, in the age of four to seven years were endodontically treated in three groups [GI, GII, GIII] alternatively. The patients were examined for clinical and radiographic symptoms prior to the procedure that was recorded. The preoperative and follow-up clinical factors are summed up in [Table 2]. Majority of the teeth presented with pain or tenderness to percussion, preoperatively. The follow-up examination revealed a marked improvement in the terms of clinical factors. Only one patient in GI reported severe dental pain in relation to the filled tooth and extraction of this tooth was done at the 6-month review. No statistical difference (p > 0.5) (Chi-square test) between the groups were noticed. Radiographic assessment showed progressive healing of the radiolucencies with the passage of time, in majority of teeth regardless of the size of radiolucencies at the preoperative examination.
None of the samples showed any change in abnormal root resorption, external resorption, internal resorption, calcific changes, deviated path of eruption of the corresponding permanent teeth on 3,6,9 month review giving a 100% success. Radiographic success was taken as the combination of decrease in furcation radiolucency, resorption of material within the root canal and complete resorption of excess filling material. Group I (p = 0.00) and Group III (0.00) was statistically significant when compared to Group II (p = 0.09).
The clinical and radiographic success rates are as follows [Table 2],[Table 3],[Table 4],[Table 5],[Table 6]:
Clinical success rate in GROUP I was 100%.Radiographic success rate in GROUP I was 81.1%.Clinical success rate in GROUP II was 96.8%.Radiographic success rate in GROUP II was 72.5%Clinical success rate in GROUP III was 100%Radiographic success rate in GROUP III was 90.32%The overall success rate between the groups was not significant statistically (p > 0.05) (Chi-square test).
Group I - 90.5%Group II - 84.7%,Group III - 95.1%.
Zinc oxide eugenol and Calcium Hydroxide are the most commonly used root canal filling materials. Castagnola showed that iodoform pastes are bactericidal to microorganisms in the root canal and lose only 20% of the potency over a 10-year period.  But Zinc oxide eugenol pastes are not bactericidal, unless mixed with drugs, such as formocresol.  Due to various side effects of formaldehyde, the use of it is questionable.  Healing depends on the ability of the root canal filling material to promote natural healing functions of periapical tissues of primary teeth. In this study, Zinc oxide eugenol with iodoform (RC FILL), in spite of a fixative agent like iodoform shows a decreased clinical and radiographic success. Five teeth showed persistent material, which did not resorb till the end of the study, which has to be reviewed later. The Zinc Oxide Eugenol in the paste could be the reason for the teeth showing persistent interradicular pathologies, and decreased resorption of excess material.
Nurko-principal advantage of Calcium hydroxide with Iodoform (VITAPEX) was that it resorbs from the apical tissues in one week to two months.  In this study, excess filling was seen in two teeth, which showed complete resorption in the 3-month's review itself. Of the 30 treated teeth, 17 teeth (56.6%) showed material resorption ahead of the roots and have followed up regularly for any symptoms. Bone regeneration has been clinically and histologically documented after using iodoform and calcium hydroxide mixtures. It was also stated that iodoform pastes had the added advantage that they do not set as hard as Zinc Oxide Eugenol pastes; removal of the material for retreatment therefore is simplified.  Six teeth (19.9)% in this study filled with Calcium hydroxide and Iodoform (Metapex) showed complete healing of radiolucency and 16 teeth showed decrease in radiolucency but not a complete healing. A similar report was done by Tchaou et al, and they were uncertain how effective METAPEX would be in cases of acute infection, as it was reported to have minimal or no anti-bacterial properties.  Carlos Nurko and Garcia Godoy- depletion of Vitapex (Calcium hydroxide and iodoform) was seen within the root canals but was asymptomatic. They said that its use in acute infections is uncertain; also, in their study pulp of the treated tooth was only affected by decay but not necrotic. 
Resorption of the material at the rate of the tooth is a criteria less met by the above materials. ENDOFLAS, a mixture of Calcium hydroxide, Zinc oxide eugenol and Iodoform is said to have the advantage of resorption limited to the excess extruded extraradicularly; without washing out intraradicularly. In this study, two cases in our study showed resorption of material at the same rate of the tooth, thus fulfilling the basic requirement of an ideal root canal filling material for primary teeth. Also seventeen teeth (54.8%) filled with ENDOFLAS showed complete healing of radiolucency over a period of time. All the teeth filled with ENDOFLAS were found to be clinically successful. A similar finding was reported by Chawla et al,  , where a mixture of Calcium Hydroxide and Zinc Oxide Eugenol was placed in the root canals. In this study, 35.48% cases showed over filling and in all the cases complete resorption of the material were seen by the 9-month review. Radiographically, 100% decrease in furcation radiolucency was seen with complete bone regeneration in 54.8% cases. Fuks et al, reported 70% success clinically with ENDOFLAS and a 100% decrease in periapical radiolucency.  High clinical and radiographic success of ENDOFLAS shows its excellent healing capabilities (54.8% complete bone healing).
Comparing all the three materials, for its clinical and radiographic properties, METAPEX - Calcium Hydroxide with Iodoform can be recommended as a root canal filling material when the tooth to be treated is free of any abscess or chronic infections and due to its resorbable nature it can be used only for those teeth, which has a lesser period of survival in the oral cavity.
ENDOFLAS - a mixture of Calcium Hydroxide, Zinc oxide Eugenol and Iodoform, with a high success rate of 95.1% can be considered to be an effective root canal filling material in primary teeth due to its healing ability, bone regeneration characteristics and its resorption of excess material without washing within the roots. However, further research has to be conducted in order to determine the effects of these materials on succedaneous tooth. This study was done on a 9-month evaluation period, hence a long-term follow-up, to determine the success rate of ENDOFLAS has to be conducted.
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