|Year : 2022 | Volume
| Issue : 3 | Page : 288-296
Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study
UdayaKumar Deepika1, Prasanna Kumar Sahoo1, Jayanta Kumar Dash1, Ratna Renu Baliarsingh1, Prayas Ray1, Gaurav Sharma2
1 Department of Pediatric and Preventive Dentistry, SCB Dental College and Hospital, Cuttack, Odisha, India
2 Department of Public Health Dentistry, SCB Dental College and Hospital, Cuttack, Odisha, India
|Date of Submission||22-Mar-2022|
|Date of Decision||03-Jun-2022|
|Date of Acceptance||13-Sep-2022|
|Date of Web Publication||18-Oct-2022|
Department of Pediatric and Preventive Dentistry, SCB Dental College and Hospital, Cuttack - 753 007, Odisha
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aim: This study aims to evaluate and compare the clinical performance of two restorative materials – bioactive resin-modified glass ionomer (ACTIVA BioACTIVE restorative) and giomer hybrid composite (Beautifil Flow Plus) in restoring class I carious primary molars. Materials and Methods: The split-mouth randomized controlled study was conducted on 100 primary molars from 50 children (28 – males, 22 – females) from 50 children in age range of 5-9 years (Mean-7.29±1.34) with at least two occlusal carious lesions on either maxillary or mandibular primary molars. Each child had both the control and the experimental teeth restored with respective restorative materials, Group I (Control, n = 50) → Giomer, Group II (Experimental, n = 50) → Bioactive resin-modified glass ionomer. The restorations were evaluated by two independent investigators using modified United State Public Health Service criteria at immediate postoperative, 6 months, and 12 months. The Chi-square test was used for the statistical analysis after collecting the data. Results: At the 12-month follow-up, 33 children (66 teeth) reported with an attrition rate of 33%. The color match between the groups was not statistically significant at all intervals. The marginal discoloration, marginal integrity, anatomic form, and retention had no significant difference at 6 months. But at 12 months, there was a statistically significant difference between the groups with p value of 0.04,<0.001,<0.02 and <0.001 respectively. respectively. At 12 months, there was no postoperative sensitivity in both groups. Conclusion: Bioactive resin-modified glass ionomer with enhanced properties can be used as an effective restorative material, especially in children with excessive salivation.
Keywords: Bulk-fill composite, flowable composite, smart materials
|How to cite this article:|
Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent 2022;40:288-96
|How to cite this URL:|
Deepika U, Sahoo PK, Dash JK, Baliarsingh RR, Ray P, Sharma G. Clinical evaluation of bioactive resin-modified glass ionomer and giomer in restoring primary molars: A randomized, parallel-group, and split-mouth controlled clinical study. J Indian Soc Pedod Prev Dent [serial online] 2022 [cited 2022 Nov 29];40:288-96. Available from: http://www.jisppd.com/text.asp?2022/40/3/288/358806
| Introduction|| |
Dental caries, multifactorial disease is the most prevalent disease affecting the worldwide population regardless of age, gender, and socioeconomic status. The prevalence of dental caries is similar at 5 and 12 years around 49% while it increases from 15 years (60%) to 35–44 years (78%) and peaks at 60–74 years at 84%. The early loss of primary teeth in children leads to an imbalance in growth and development of oral and maxillofacial apparatus resulting in crowding of teeth, development of deleterious habits, and skeletal malformation leading to malocclusion. The primary objective of managing the carious teeth in children is a challenging task and needs both the preventive and restorative aspects either by the application of fluoride or restoration of carious teeth with a suitable material that chemically bonds to enamel and dentin and also withstands the masticatory load.
In recent times, with the help of modern technology, newer restorative materials were introduced. The active materials which interact directly or indirectly with the changes in the oral cavity are named smart materials. Another category of materials that affect, or elicit a response from living tissue, organisms, or cell such as inducing the formation of hydroxyapatite are bioactive materials. The mechanism of action of bioactive material is the solubilization of proteins from dentin exposed to materials such as calcium hydroxide, mineral trioxide aggregate, and acidic solutions used in dentin bonding agents resulting in modulation of gene expression in odontoblast cells leads to dentin bridge formation.
Giomer is a smart hybrid restorative material, introduced in 2000 (Shofu Inc., Kyoto, Japan) contains a stable glass–ionomer phase on a glass core that induced an acid-base reaction between fluoride-containing glass and polycarboxylic acid in the presence of water developed as pre-reacted glass-ionomer (PRG) filler. The second-generation giomer is composed of the surface reacted-PRG (S-PRG) filler that avoided water absorption tendency and expansion that was reported in restorations of the first-generation giomer composed of the fully reacted-PRG filler. Improvement in the PRG technology results in the development of a Modified “S-PRG filler” which consists of a three-layered structure with an original glass core of multifunctional fluoroboroaluminosilicate glass and two-surface layers that form a PRG-ionomer phase on the surface of a glass core and a reinforced modified layer that covers the surface of PRG-ionomer phase. Fujimoto demonstrated that the new fluoride-releasing restorative system with modified S-PRG filler also releases the F-ion as well as other ions such as Al, B, Na, Si, and Sr.
A new bioactive bulk-fill restorative material (ACTIVA-Restorative, Pulpdent, Watertown, MA, USA) was launched in 2013 and later termed as enhanced RMGIs. The bulk-fill restorative material reduces the number of increments and the time consumed. It is the first dental resin with a bioactive ionic resin matrix, shock-absorbing rubberized resin component, and reactive ionomer glass fillers that mimic the physical and chemical properties of natural teeth. Activa consists of diurethane modified with hydrogenated polybutadiene methacrylate monomers, modified polyacrylic acid, sodium fluoride, bioactive glass filler, silica, and camphorquinone while there is no bisphenol A, no bisphenol A-glycidyl methacrylate, and no bisphenol A derivative. They are two-paste, automix systems with three setting mechanisms: light cure, self-cure resin chemistry, and self-cure glass ionomer reaction.
This study is designed to evaluate and compare the clinical performance of bioactive resin-modified glass ionomer (ACTIVA Bioactive restorative) with giomer hybrid resin composite in primary molars with the occlusal carious lesion.
| Materials and Methods|| |
This was a single-center, split-mouth, randomized- controlled study performed with 50 children of both sexes (males – 28, females – 22) in the age range of 5–9 years who had at least two occlusal carious lesions on either maxillary or mandibular primary molars with 1:1 allocation approved by the Institutional Ethical Committee (IEC/SCBDCH/052/20). The null hypothesis considered that there would be no difference in the clinical performance of both the restorative materials over 12 months.
Using the computer application Using the G*Power software (latest version- 184.108.40.206; Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany), the required sample size was determined., the required sample size was determined with the given α =0.05, power = 0.85, and effect size = 0.8 (assuming the large effect size difference between the groups), to be 30 teeth per group. To rule out the error caused by dropout, 50 teeth per group were considered.
Participants were recruited from patients who reported to the outpatient clinic in the department of pediatric and preventive dentistry from January 2019 to October 2020.
Informed consent was obtained from parents/caregivers of the children after explaining the details of the treatment procedure in a designated format in regional and English languages.
All the participants of the study were recruited based on the following inclusion and exclusion criteria.
- Bilateral cavities in the occlusal surface of the maxillary and mandibular primary molars International Caries Detection and Assessment System (ICDAS II codes 4, 5)
- Teeth without any developmental defects such as hypomineralization, hypoplasia, and fluorosis
- Asymptomatic and vital teeth without pulpal involvement
- Teeth without periodontal or periapical pathosis.
- Patients with medical conditions or diseases
- Anxious or uncooperative patients
- Parents who were not willing to participate in the study.
Randomization and blinding
The investigator was trained and standardized by the principal investigator to calibrate different variables for the identification of occlusal caries using ICDAS II criteria (Code 4, 5) and to evaluate the restorations using modified United State Public Health Service (USPHS) criteria. The randomization sequence was a computer-generated sequence from www.random.com. Those randomized sides were allotted to the experimental group and the contralateral sides were to the control group. Both the participants and investigator were blinded.
It was a split-mouth study. Hence, every child had both control and the experimental tooth restored with respective restorative material either contralateral or ipsilateral in the different arch. The selected teeth were randomly allocated to two groups according to the restoration provided.
- Group I (Control, n = 50) → Giomer (Beautifil flow Plus F00, Shofu Inc., Kyoto, Japan)
- Group II (Experimental, n = 50) → Bioactive resin-modified glass ionomer (ACTIVA Bioactive restorative, Pulpdent, MA, USA).
After rubber dam isolation, the carious dentin was removed with the round diamond bur no. 6 using a high-speed handpiece and adequate water coolant. The cavities are restored with the respective restorative materials.
Group I: The internal surfaces of the cavities were conditioned by a layer of adhesive agent (Beautibond, Shofu Inc., Kyoto, Japan) both on enamel and dentin with the micro brush and left undisturbed for 10 s, gently dried with an oil-free airway syringe for 3–5 s until a thin and uniform bonding layer was obtained. Then, the bonding agent was polymerized for 5 s with a light-emitting diode (LED) light-curing unit (Woodpecker 1 LED: wavelength 440–490 nm and intensity 1200 mW/cm2). Giomer material (Beautifil flow Plus F00, Shofu Inc., Kyoto, Japan) was placed directly into the cavity in an incremental fashion of 2 mm and each layer was polymerized for 10 s. The final occlusal layer is placed, adapted, and curved to the desired shape with a composite filling instrument.
Group II: The internal surface of the cavities was conditioned with an etchant (38% phosphoric acid; Ultradent Ultra-Etch®) for 10–15 s and rinsed. The cavity was lightly dried to remove all the excess moisture with high volume compressed air, and/or a cotton pellet, taking care not to desiccate the dentin. The bonding agent (Ivoclar Vivadent Te-econom Bond) was applied with the micro brush and left undisturbed for 10 s, then gently air-dried with an oil-free airway syringe. The bonding agent was polymerized for 10 s with an LED light-curing unit (Woodpecker 1 LED: wavelength 440–490 nm and intensity 1200 mW/cm2). The cavity was restored with the Bioactive resin-modified glass the ionomer (ACTIVA Bioactive restorative, Pulpdent, MA, USA) by inserting the tip of an auto mix syringe on the floor of the prepared cavity and firm pressure is applied to the plunger. Then, the entire cavity of 4 mm depth was filled by placing the tip of the syringe submerged in the material with the occlusal movement from the bottom of the cavity toward the occlusal surface using firm pressure. Then, the material was shaped with the composite filling instrument and polymerized for 20 s after the initial 20 s.
The cavity margins are checked for any voids, gaps, and occlusion was checked for any high points. Both the materials are finished and polished (Shofu Super Snap polishing disc).
The restorations were evaluated by an independent investigator at immediate postoperative, 6 months, and 12 months using modified USPHS criteria. All the collected data were analyzed statistically using the Chi-square test and a P < 0.05 was considered statistically significant.
| Results|| |
Of 50 children (100 teeth), 4 children experienced pain within 6 months were excluded from the study and underwent an appropriate treatment procedures. Due to the pandemic COVID-19, only 33 children (66 teeth) were evaluated in both the follow-up period. The demographic distribution of study participants according to gender and teeth is described in [Table 1]. [Figure 1] is a flowchart representation of participants from the initial phase till the 12 months follow-up.
|Table 1: Demographic distribution of study participants according to gender and teeth|
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|Figure 1: Flowchart representing the patients evaluated in both the groups|
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The color changes in both the restorative materials were not statistically significant in all three-time intervals [Table 2]. The marginal discoloration and marginal integrity were nonsignificant between the groups at immediate postoperative and 6 months, while at 12 months showed statistical significance difference with P = 0.04 and P < 0.001, respectively. Anatomic form and retention had a nonsignificance difference between the two groups at immediate postoperative and 6 months. At the 12-month follow-up, there was a statistically significant difference with P = 0.02 and P < 0.001, respectively [Table 2].
|Table 2: Intergroup comparison of all the criteria at various follow-up visits|
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The intragroup evaluation of giomer revealed that there was a statistically significant difference at all three-time intervals in a color match and anatomic form with a P < 0.05. While marginal discoloration and retention were statistically significant from 6 months to 12 months, marginal integrity did not undergo remarkable changes from immediate postoperative till 12 months. In ACTIVA bioactive group, the color match had a significant difference at all three-time intervals with a P < 0.05. The anatomic form had a significant difference from immediate postoperative till 6 months after which there were no noticeable changes in the anatomic form of the restorations. The marginal discoloration and retention had a significant difference from 6 to 12 months [Table 3], [Table 4] [Table 5].
|Table 3: Intragroup comparison of both the groups from immediate postoperative till 6 months|
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|Table 5: Intragroup comparison of both the groups from immediate postoperative till 12 months|
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At 6 months, one participant had postoperative sensitivity on both the restorations which was constant does not diminish in intensity. At 12 months, on evaluation of 66 restorations (33 children), there was no postoperative sensitivity in both the groups. Within 6 months, 4 participants out of 50 children reported with pain, on evaluation two participants had pain in both the restorations and other two participants had pain in alternative restorations. These participants underwent an appropriate treatment procedure to relieve pain and were excluded from the study. At 12 months, from the evaluation of 66 restorations, there were no complications in both the groups.
| Discussion|| |
It is important to maintain the primary dentition in a healthy condition for the well-being of the child and for proper mastication, aesthetics, phonetics, space maintenance, growth and development of the craniofacial structure, and to prevent the development of aberrant habits. Resin composites are being widely used for many years in the restoration of posterior primary teeth. The limitations of resin composite materials are technique sensitivity, shrinkage stress, microleakage, postoperative sensitivity, and time factor. Bulk-fill composite was introduced to fill up the occlusal area of deep caries in a single step as a single bulk increment up to 4 mm reducing the number of composite layers with an advantage of less time consumption and polymerization shrinkage.
This study was conducted on the clinical performance of the giomer hybrid resin composite and bulk-fill bioactive resin-modified glass ionomer restorations in occlusal cavities of primary teeth. The study was performed as a prospective, double-blind randomized control study in 42 children with a split-mouth technique (SMT). This design has the advantage of a significant decrease in the study's variability or random error and inter-subject variability in terms of diet, brushing habits, masticatory forces, and oral environment (saliva flow rate, salivary pH) on the longevity of restorations and also increases the power to detect real differences. There is a disadvantage in this design known as the carry-over or carry-across effect which is nullified because the clinical performance of the materials is compared not the fluoride-releasing effect so, SMT is justified and more accurate for this study. Another problem encountered by SMT is the recruitment of the subjects with identical caries on both sides of the mouth. All restorative procedures were performed by one dentist to eliminate the limitation of variant skills of different operators. The clinical evaluation was performed by an independent investigator who was blind to the type of material used.
ACTIVA bioactive restorative material is a bioactive composite with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth. Furthermore, it chemically bonds to the tooth through ionization reaction and forms a strong resin-hydroxyapatite complex thereby sealing the tooth against microleakage. It has the advantage of not containing bisphenol A, bis GMA which reduces the toxicity of this material because research revealed that a short-term administration of bis-GMA and/or bisphenol A in animals or cell cultures can induce changes in estrogen-sensitive organs or cells.
This study revealed that there was no difference in the color match between the giomer hybrid resin composite and bioactive resin-modified glass ionomer at all three-time intervals. All restorative materials showed clinically perceptible color differences after exposure to food dyes in the oral environment to time. An in vitro study concluded that materials with a large amount of filler showed greater discoloration, but in this study both the materials had an equal amount of filler. Under normal curing conditions, urethane dimethacrylate material showed lower water sorption than bis-GMA. The water uptake of bis-GMA-based resins is directly proportional to the concentration of TEGDMA. Giomer hybrid resin composite is based on a bis-GMA, TEGDMA showed more stain susceptibility than material containing urethane dimethacrylate.,
The intergroup comparison in the maintenance of marginal integrity and color is better in bioactive resin-modified glass ionomer than giomer hybrid resin composite at 12 months. An ex vivo study comparing giomer hybrid resin composite and ormocer concluded that the latter had less microleakage.
There was no statistically significant difference between the groups at immediate postoperative and 6 months but at 12 months, there was a statistically significant difference (P = 0.02) that giomer hybrid resin composite had less ability in maintaining the anatomic contour of the restoration than bioactive resin-modified glass ionomer. These results were following an in vitro study that compared the wear and abrasive pattern of enhanced resin-modified glass ionomer restorative material, resin composite, resin-modified glass ionomer, and glass ionomer and concluded that wear of enhanced resin-modified glass ionomer was equivalent to resin composite and superior to resin-modified glass ionomer and glass ionomer. A systematic review concluded that higher HEMA content in giomer hybrid resin composite resulted in increased water adsorption leading not only to color change but also to degradation of the material.
At 12 months, the retention of the bioactive resin-modified glass ionomer is better than the giomer hybrid resin composite and it is statistically significant (P < 0.001). This result was following the study comparing giomer hybrid resin composite with resin-modified glass ionomer and nano ionomer which concluded that giomer had poor retention compared to other restorative materials. A systematic review conducted on the longevity of giomer concluded that at 6 years, the HEMA-containing self-etching adhesive -giomer hybrid resin composite restorations showed a high frequency of failure. The manufacturer of ACTIVA bioactive mentioned that the material has a shock-absorbing rubberized resin component which might be resulting in better retention.
At 12 months, after the dropout of 11 participants, there was no postoperative sensitivity, complications (pain/swelling/fistula), and furcal radiolucency in both the groups. The previous in vivo studies were following this study and concluded no postoperative sensitivity.,, The study on three bulk-fill materials ACTIVA, Cention N, and Equia forte evaluated the postoperative sensitivity using a visual analog scale and concluded that ACTIVA had the least postoperative sensitivity after 24 h while absent after 1 week and 1 month.
Limitations of the study
The evaluation was subjective with the weakness in perceiving changes in retention, anatomic form, color match, marginal integrity, and marginal discoloration that cannot be measured accurately without the use of sophisticated tools. The evaluation by modified USPHS criteria is difficult to distinguish between the scores Alpha and Bravo to arrive at a definitive conclusion. The accurate method to measure these criteria should be objective which would reduce the manual error caused by fatigue during the evaluation.
The short follow-up period resulted in inadequate data on the long-term performance of the restorative materials. There are numerous in vitro studies on bioactive resin-modified glass Ionomer which cannot reveal the in vivo longevity of these tooth-colored restorations. Thus, many in vivo studies are recommended with a long-term follow-up.
| Conclusion|| |
- The color change and marginal discoloration from ideal to acceptable score occurred in both materials
- Bioactive resin-modified glass ionomer showed better marginal integrity because of its sealing ability and it was statistically significant
- Bioactive resin-modified glass ionomer had better anatomic form and retention compared to that of giomer
- Hydrophilic restorative material, bioactive resin-modified glass ionomer with enhanced properties can be used as an effective restorative material, especially in children with excessive salivation where isolation is a problem.
Although both the materials showed promising results, long-term studies are necessary to determine the potential benefits of the materials.
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], [Table 5]