Cairo Dental Journal (24) Number (2), 177:185 May, Hana M. Jamjoom 1. Abstract INTRODUCTION

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1 Cairo Dental Journal (24) Number (2), 177:185 May, 2008 Clinical evaluation of directly pulp capped permanent teeth with glass ionomer materials Hana M. Jamjoom 1 1. Associate Professor Conservative Department, King Abdulaziz University, Saudi Arabia Abstract Direct pulp capping is the most conservative restorative procedure for protecting the pulp from further insult, permitting healing and repair. Calcium hydroxide is the most commonly used materials for direct pulp capping. The aim of this study was to compare clinically and radio graphically with Resin modified glass ionomer (RM-GIC) as a direct pulp capping material. Forty six teeth were selected for pulp capping; they were divided to 2 groups. Group I. 20 cases of Resin modified glass ionomer (RM-GIC) (Vitrebond), Group II 26 cases of Ca (OH) 2 (Dycal) were applied in 0.5 mm exposure. All teeth were treated under rubber dam isolation and filled with composite then recalled after 3 weeks, 3 month, and 6 month for clinical and radiographical assessment. Eighty three percent of the cases were recalled. The age of the participants ranged from 13 to 52 years, with a mean of 29.4 ± 10, 70% of those cases were diagnosed as asymptomatic carious lesion and 30% had reversible pulpits. Clinically, had the lowest success having four failed cases after six month recall, while the glass ionomer had no failure through out the study. Significance in clinical success between glass ionomer and in the 6 month period P=.039. Also there was high significance within recall period of 3 weeks and 3 month.004, and 3 weeks and 6month (.019). Radiographically, withdrawal in success by time shows an increase in percentage of pathological change through the follow up recall periods. In conclusion Glass ionomer was stable all thru the study period with the highest success in comparisons to the. Key words: Pulp capping, direct, permanent teeth, glass ionomer,, clinical signs INTRODUCTION Direct pulp capping is a vital pulp therapy technique which aims at maintaining pulpal tissues viability by protecting the pulpal system from bacterial ingress and hence enhancing its reparative capacity. Bridging off the communication site with new dentine is a prerequisite for the long term success of direct pulp capping treatment (27,30). The potential for tooth recovery after pulp exposure depends on several factors such as the pulp status, the pre-operative and post-operative prevention of bacterial

2 (178) Hana M. Jamjoom C.D.J. Vol. 24. No. (II) infection, the size of exposure and the efficacy of treatment strategy (4,23,35). It is generally accepted that wound healing after pulp capping treatment is not unique to a given treatment modality (28). Calcium hydroxide was generally the material of choice for the capping of vital pulp that has been accidentally injured (32). Dentists used calcium hydroxide because of its antimicrobial properties (18,25) and its ability to induce hard tissue formation the inability of calcium hydroxide to provide permanent seal and the porous nature of the bridge allows the ingress of bacteria and inflammatory bacterial products. (21) These irritants can compromise pulpal vitality, often leading to dystrophic calcification, root canal therapy, or potential extraction (3,7,12,21,37). These disappointing results of calcium hydroxide have prompted the search for other capping materials. Another material that have been used is the early generation of glass ionomer cements, that possessed two important feature: binding to both enamel and dentin in addition to their immediate fluoride release, which is of major cariostatic importance for patients who have high caries risk (36). But its sensitivity to desiccation and moisture contact during the early stage of setting, and the low mechanical wear resistance under stress bearing area (22) are important factors, which if not properly controlled, may present disadvantages that will result in long term clinical failure. Resin Modified Glass Ionomer Cement (RM-GIC) is a recent modification to glass ionomer cement. In vitro reports have suggested that microleakage is reduced with the use of RM-GIC (13,29). A study evaluated RM- GIC as a direct pulp capping was as successful as with (33). Also in a recent investigation the RM-GIC reacted favorably to exposed monkey pulpal tissue forming dentin bridge after 21 days. (15,33) Up to date, there is no clinical study that investigated the effect of using RM-GIC as a direct pulp capping material over the exposed vital pulp of permanent teeth, which this study will attempt to do so. The aim of this study is to evaluate the efficacy of resin modified glass ionomer cements when used as a direct pulp capping material in human permanent teeth comparing it with the current gold standard calcium hydroxide material. Materials and Method Forty six fully matured permanent anterior or posterior teeth were selected from patients ranging years of age, attending the restorative department seeking dental treatment. Patients were selected and treated by two operators according to strict clinical inclusion criteria. An approval from the ethical committee in the hospital medical board was achieved. Patients signed a consent form after receiving a thorough explanation about experimental rationale, clinical procedure and possible risk. All patients were exposed to the same surgical protocol with the only difference being the tested material. The efficacy of each material as a therapeutic modality for preserving pulpal vitality was assessed by a recall program. These steps are detailed as follows Clinical examination and inclusion criteria a. Adult patient above 13 years with permanent teeth that has signs and symptoms of healthy pulp or reversible pulpits and radiographic evidence of root end closure. b. Symptoms of reversible pulpits, which is characterized by mild-moderate pain to thermal changes. This pain got to be characterized as non-lingering upon removal of the stimulus and non spontaneous. c. These symptoms will then be confirmed clinically in examination form by carrying out the following tests: i. Cold testing by applying Endo-Ice frozen gas (Coltene/Whaledent Inc, Mahwah, NJ, USA) for 5 seconds on the buccal surface of the teeth scheduled for pulp therapy and adjacent teeth. ii. Percussion testing to predict the periradicular involvement of the offended tooth which is an indication of irreversible changes in the pulp and hence disqualify the tooth for inclusion. Positive result is indicated by pain on percussion compared to the control teeth.

3 Clinical evaluation of directly pulp (179) iii. Palpation testing to predict the extent of the periradicular bone involvement. This test is carried out by bi-manual palpation of two quadrants at the depth of the buccal sulcus. Pain on palpating is indicative of spread of infection to the endoseam. Preoperative radiographic examination taken in parallel technique with the aid of x-ray film positioning device rim (Dentsply, Petropolis, RJ, Brazil) for standardization. The purpose of these films is to characterize the radiographic signs that are indicative of periradicular bone destruction and thus pulpal irreversible involvement. Operative procedure: Upon patient selection teeth were assigned randomly to one of the two groups: Ca(OH) or RM-GIC 2 (Table 1). The operative protocol and the recall system were virtually identical in all cases with the difference only being the capping material. After local anesthesia (Citanest 3%, Merrel Lepetit, Sao Paulo, Brazil), rubber dam isolation was implemented on the assigned tooth. Then all destructed enamel and carious dentin were drilled out using sterile carbide bur # 245. The convenience form was obtained and the rest of the decay is scooped out with spoon excavator. Upon observing the pulp exposure, sterile round bur with the appropriate size (1/4, or ½) was used to widen the exposure site to standardize the exposure diameter in all the tested cases. Bleeding was controlled by irrigating the cavity with 5.25% Sodium hypo chlorite (NaOCl) applied by a disposable syringe. Pressure was applied with a cotton pellet until homeostasis is achieved. Then the capping material was applied according to manufacturer instruction. Table (1) Commercial name, Company name and composition of the material used. commercial Name Company Name Composition Dycal Dentsply,Petropolis, RJ, Brazil Base paste: ester glycol salicylate calcium phosphate, Ca tungstate and ZnO. Catalyst paste:ethylene toluene sulfur amide, ca (OH)2, ZnO, Ti 2 0 Resin Modified Glass Ionomer (RM-GIC) Vitrebond 3M. ESPE, St. Paul, MN, USA Powder-fluro aluminosilicate glass camphor quinine. Liquid-Acrylic-Itaconic acid copolymer with pendent. Methacralate groups, 2HEMA, water, photo-activator Composite Z100 3M ESPE, St. Paul,MN, USA Bis-GMA, TEGDMA and Silica/ Zirconium Filler. Rim Holder Rinn holder Elgin III Dentsply Petropolis, RJ, Brazil X-ray holder Adhesive ScotchBond Multi purpose Plus 3M ESPE, St. Paul, MN USA Etchant:37% phosphoric Aid Primer: Water (40%), HEMA (47%) and Polialkenoic Acid Copolymer (13%) Adhesive: Bis-GMA (65%), HEMA (34%) and initiators/accelerators (1%)

4 (180) Hana M. Jamjoom C.D.J. Vol. 24. No. (II) RM-GIC group I: A fresh mix of Vitrebond ( 3M ESPE, St Paul, MN, USA ) powder and liquid ratio 1:1 is mixed on a paper pad, RM-GIC is introduced to the exposure site using a hand instrument with a small round tip, then cured for 20 second using Heliolux light cure machine (Vivadent, Schaan, Liechtenstein). Light cure machine was monitored using Demetron light radiometer (Cure-rite-USA) group II: A fresh mix of Dycal,( Dentsply, Petropolis, RJ, Brazil) was applied to the exposure site using a hand instrument with a small round tip Cavity Restoration: After application of pulp capping material each cavity was etched with 37% phosphoric acid for 15 seconds (Table 1). Then washed for 10 seconds with water and air blotted. Primer is applied with a brush and air thinned. Then one layer of adhesive is applied on the cavity and cured for 20 seconds. Composite Z-100(3M, ESPE, St Paul, MN, USA) is applied in increments of 2mm thickness, each increment is cured for 40 seconds. Then occlusion checked and restoration is finished and polished. Recall system: Patients were recalled for clinical (cold, percussion and palpation test) and radiographic examination after 3 weeks, 3month, and 6month.All mean were taken for the patients recall examination to be done within certain period. Eight cases couldn t be contacted for recall after 3 weeks as a result of moving away, wrong number or left the country and others responded that they were satisfied and cannot come. Also some patient came the first recall and refused to come the second or third recall session this was due to no complain arose from the treated tooth. The case was regarded as a failure when one or more of the following signs were present as negative vitality response, periapical radioluceny, widening of the lamina dura, pain, or swelling Statistical analysis: Statistical analysis was done using SPSS (Statistical package for social science) version 10. The quantitive data were presented in the form of mean, standard of deviation and range. Student t-test was used to compare quantitive data of the two groups. The quantitive data were presented in the form of numbers and percentage. Chi-square with Yates correction was used to compare between qualitative data of tests groups. To compare between qualitative data within the same group (follow up) McNemor test was used. Significance was considered at P value less the.05. Results From the forty six cases that were treated 2 cases for glass ionomer and 6 cases for didn t show up for recall. The age of the participants ranged from 13 to 52 years, with a mean of 29.4 ± 10 For RM-GIC and 28.1±11.7 for the group in the forty six cases that was recalled. The chief complaint presented at examination for both group was mainly caries/ cavity, and pain. The majority of participants in both group had no history of complaints (60%-69%). Diagnosis at examination for both groups was caries with average percentage of (70%) and reversible pulpitis (30%) (Table 2). Clinically, had the lowest success having four failed cases after six month recall, while the glass ionomer had no failure through out the study. Significance in clinical success between glass ionomer and in the 6 month period P=.039. Also there was high significance within recall period of 3 weeks and 3 month.004, and 3 weeks and 6month.019 (Table 3). Radiographically, withdrawal in success by time shows an increase in percentage of pathological change through the follow up recall periods. Glass ionomer was stable throughout the study period. Significance at the recall between the first visit and 3 month, and the 6 month (P=.039,.047) respectively. While the glass ionomer had 2 cases at the start with widening of the lamina dura and they had the same radiographic picture through out the

5 Clinical evaluation of directly pulp (181) study (Table 4). Correlating the response to cold stimuli between the 2 materials, a high significance existed at the period of recalls between the groups and within each group at the 3weeks- 3month, and 3week and 6month recall (Table 5). Their was reduction in cold response through the recall period for the group (Fig 1). Table (2) Sample description Variables Glass ionomer Test of significane Age Chief complaint History of chief complaint Diagnosis Min- max Mean ± SD ± ± Caries 6 (30) 12 (46.2) check up 2(10) 6(23.1) Need Restoration 2(10) 2 (7.7) Pain 10(50) 6 (23.1) No symptoms 12(60) 18(69.2) Caries 8(40) 8(30.8) Caries 14(70) 18(69.2) Pulpitis 6(30) 8(30.8) P=.32 P=.23 P=.36 P=.78 Table (3) Comparison of clinical manifestations in different follow up periods between, glass ionomer and groups. Recall Glass ionomer Test of significance 3weeks N=20 Success failed (90%) 2 (10%).48 3 months Success failed (77.8%) 4 (22.2%).11 6 months N=16 Success failed (75%) 4 (25%).039** 3wk-3mth 1.004** 3wk-6mth 1.019* 3mth-6mth **P<.01

6 (182) Hana M. Jamjoom C.D.J. Vol. 24. No. (II) Table (4) Comparison of radiographic signs in different follow up periods between glass ionomer & groups Recall Glass ionomer Test of significance First visit N=20 N=26 Normal 18 (90%) 22 (84.6%).68 pathological 2 (10%) 4 (15.4%) 3 months normal 16 (88.9%) 14 (77.8%).68 pathological 2 (11.1%) 4 (22.2%) 6 months N=16 Normal 16 (88.9%) 10 (62.5%).109 pathological 2 (11.1%) 6 (37.5%) 3wk-3mth * 3wk-6mth * 3mth-6mth Table (5) Response to cold stimuli in different follow up periods between glass ionomer & groups Recall Glass ionomer Test of significance 3weeks N=20 yes 18 (90%).004** no (10%) 3 months yes 14 (77.8%).001*** no (22.2%) 6 months N=16 yes 12 (75%).001*** no -- 4 (25%) 3wk-3mth.001***.004** 3wk-6mth.001***.012* 3mth-6mth *P<.05, **P<.01, ***P<.001

7 Clinical evaluation of directly pulp (183) Fig. (1) Response to cold stimuli in different follow up period between glass ionomer an C(OH) 2 gr Discussion In this study the response of recalled cases was 83%, showing high clinical and radiographical examination success for glass ionomer materials vs. the. Although the number of cases was considered small in some groups but clinical research on patients are difficult to control and collect. Also finding patients with the research set criteria is very difficult and require long time. Usually dental patients seek dental help when they are in pain, so one can make an assumption that some of the patients who didn t show up in the recall are not complaining and are satisfied. Also the results of clinical success achieved in this study are considered unique, because carious teeth with pulp exposure were treated although the level of inflammation is much higher, questionable and more difficult to predict than clinical studies on pulp therapy in sound teeth. All of the teeth had no history of sign or symptoms and responded within normal limit to pulp testing at the time of treatment. The outcome of success of in vital pulp ranged from 62-75% this is in agreement with other studies (10,11,20). The criteria set for case selection helped in the large percentage of success in all capping materials. Success rate in terms of maintaining the vitality of the tooth as assessed by a response to thermal or electrical stimulus with original coronal restoration intact was 100% for RM-GIC, and dropped to 75%. The prevention of contamination during restorative procedure by using rubber dam is an important factor that increased the success of this study. This is documented in the result of another study, which used adhesive for direct pulp capping with/without rubber dam. Greater failure rate were documented for cases with no rubber dam isolation, where 60% of the specimen had abscess and 40% demonstrated the presence of chronic inflammation (1). These results explain that direct pulp capping preformed without rubber dam increases the invasion of bacteria during the operative procedure which further worsens the pulp response (2,19,34) Certain controversies persist regarding the biocompatibility of various RM-GIC systems on pulpal tissues. The RM-GIC pulpal response clinically and radiographically in this study showed high success in relation to. This could be due to RM-GIC has provided a complete seal against bacterial micro leakage, due to the antibacterial characteristic of the material that has been documented (31).In a histological study, the use of RM- GIC allowed reorganization of soft tissue as well as new dentin bridge formation beneath the exposure site having a similar histological response as to directly capped monkey pulpal tissue (33). In contrast, other studies had pulpal inflammation under RM-GIC in direct pulp capped monkey teeth. This could be a result of chemical irritation or infection caused by bacteria growing in the space between the material and cavity wall, or the result of the placement procedure or material tested (24,26,31). It is interesting to note that most of the studies reporting acceptable biocompatibility of capping materials over exposed pulps were conducted on monkey or rats (2,8). However these findings were not reproducible in human teeth (6,14), never the less they are in agreement with the result of this study. The extrapolation of the results obtained from animal teeth to human dentition may be possibly due to resin components that produces more immuno suppression of pulpal immuno competent cells in human than they do in monkeys or other animals (5,16). Irrespective of the direct pulp capping material,

8 (184) Hana M. Jamjoom C.D.J. Vol. 24. No. (II) the important factors for the success of direct pulp capping are diagnosis, degree of trauma, control of bleeding and proper isolation to exclude bacteria and saliva in the exposed area (9,17). Further clinical studies are needed to test the efficacy and long term success of RM- GIC use as a direct pulp capping. 5. Carvallo RM, Lanza LD, Mondelli J, Tay FR & Pashley DH. 6. Side effects of resin-based materials in Tagami J, Toledano M & Prati C (Edit) Advanced Adhesive Dentistry 3 rd International Kuraray Symposium, Granada, Spain, 4 Dec Costa Ca, Mesas AN & Hebling J. Pulp response to direct capping with an adhesive system: Am J Dent 2000b; 13(2): Conclusion Our primary findings showed that under the conditions of this study and with the detailed surgical protocol that was used, Glass Ionomer cements had the highest success rate amongst the tested materials (100%), while had 75% success in spite the fact that considerable number of the patients in this group showed up for the recall. Glass ionomer was stable all thru the study period with better success rates, while was the material with the high percent of failure clinically, radiographically and the highest sensitivity to cold. The efficacy of RM-GIC as a direct pulp capping material is really promising but further long term clinical investigation is needed. Acknowledgment: Great thanks to King Abdulaziz Research Center for funding the research 1. REFERENCES: Accorinte M, Reis A, Loguercio A, Cavalcanti de Araujo V, Muench A. Influence of rubber dam isolation on human pulp responses after capping with calcium hydroxide and an adhesive system. Quint Int 2006; 37: Akimoto N, Momoi Y, Kolno A, et al. Biocompatibility of 3. Clearfil Liner Bond 2 and Clearfil AP-X system on nonexposed and exposed primate teeth. Quint Int 1998; 29: Barnes JE, Kidd EA. Disappearing Dycal. Br Dent J 1979; 147(5): Cox CF, Subay R, Ostro E, Suzuki SH. Tunnel defects in dentin bridges: their formation following direct pulp capping. Oper Dent 1996; 21:4-11 Cox CF, Hafex AA, Akimoto N, et al. Biocompatibility of primer, adhesive and resin composite systems on non-exposed and exposed pulps of non-human primate teeth. Am J Dent 1998; 11(special issue):s55-s63. Cox CF, Tarim B, Kopel H, Gurel G & Hafez A. Technique sensitivity; Biological factors contributing to clinical success with various restorative materials. Adv Dent Res 2001; 15: Cvek M. A clinical report on partial pulpotomy and capping with calcium hydroxide in permanent incisors with complicated crown fracture. J Endod 1978; 4: Fuks AB, Gavra S, Chosack A. Long-term follow up of traumatized incisors treated by partial pulpotomy. Pediatr Dent 1993; 15: Goldberg F, Massone E, Spielberg C. Evaluation of the dentin bridge after pulpotomy and calcium hydroxide dressing. J Endod 1984; 6(7): Hallet KB, Garcia Godoy F. Microleakage of resin-modified glass ionomer cement restorations: An vitro study. Dent Mater 1993; 9: Horsted-Bindslev P, Vilkins V & Sidlauskas A. Direct capping of human pulps with a dentin bonding system or with calcium hydroxide cement. Oral Surg, Oral Med, Oral Patholo, Oral Radiol and Endodo 2003; 96(5): Huang FM, Chang YC. Cytotoxicity of resin-based restorative materials on human pulp cell cultures. Oral Surg Oral Med Oral Pathol Oral Radiol and Endodo 2002; 94(3): Camp JH, Barrett EJ, Pulver F. In: Coxen S, Burns RC, 16. Jontell M, Hanks CT, Bratel J & Bergenholtz G. Effects of editors. In pediatric endodontics: Endodontics treatment for unpolymerized resin components on the function of accessory the primary and young, dentition, 8 th ed. St. Louis, USA: cells derived from the rat incisor pull. J Dent Res. 1995; Mosby; p (5):

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