|Year : 2019 | Volume
| Issue : 1 | Page : 92-98
Retention of moisture-tolerant fluoride-releasing sealant and amorphous calcium phosphate-containing sealant in 6–9-year-old children: A randomized controlled trial
Sachin Gowardhan Khatri1, Kavita Ashok Madan2, Samuel Raj Srinivasan3, Shashidhar Acharya4
1 Department of Public Health Dentistry, Government Dental College and Hospital, Nagpur, Maharashtra, India
2 Department of Dentistry, Government Medical College and Hospital, Gondia, Maharashtra, India
3 Department of Public Health Dentistry, Saveetha Dental college, SIMATS, Chennai, Tamil Nadu, India
4 Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal University, Manipal, Karnataka, India
|Date of Web Publication||25-Feb-2019|
Dr. Sachin Gowardhan Khatri
Plot No. 81 A, Flat No. 102, Manjushree Apartment, Hanuman Nagar, Nagpur - 440 009, Maharashtra
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Context: Pits and fissures of teeth have been recognized as the most susceptible areas for initiation of caries. The ability of the resin sealant to thoroughly fill pits, fissures, and/or morphological defects and remain completely intact and bonded to enamel surface is the primary basis for its caries prevention. Aim: The present study evaluated and compared the retention rates and development of caries in permanent molars of children sealed with amorphous calcium phosphate-containing (Aegis™) and moisture-tolerant fluoride-releasing (Embrace WetBond™) sealant over a period of 1 year. Settings and Design: This was a double-blind, split-mouth, randomized controlled trial among children aged 6–9 years. Methods: Sixty-eight permanent mandibular first molars in 34 children were randomly assigned to be sealed with Aegis™ or Embrace Wetbond™ sealant. The follow-up examinations were conducted at 3, 6, and 12 months for evaluating the retention and development of caries. Statistical Analysis: SPSS version 16.0 was used for the analysis. Within-group comparison of retention and development of caries at 3, 6, and 12 months was evaluated using the Friedman's test. Results: The final sample was 32 children with 64 teeth. At 12 months, 23 of 32 (72%) sealants were completely retained in Aegis™, whereas 21 of 32 (65.6%) were retained in Embrace Wetbond™ group. There was no significant difference in the retention rates of Aegis™ and Embrace Wetbond™ sealants at 12 months (P > 0.05). Conclusion: Aegis™ was superior to Embrace Wetbond™ sealant as Aegis™ exhibited higher retention and lower caries scores.
Keywords: Amorphous calcium phosphate, children, moisture-tolerant sealant, retention
|How to cite this article:|
Khatri SG, Madan KA, Srinivasan SR, Acharya S. Retention of moisture-tolerant fluoride-releasing sealant and amorphous calcium phosphate-containing sealant in 6–9-year-old children: A randomized controlled trial. J Indian Soc Pedod Prev Dent 2019;37:92-8
|How to cite this URL:|
Khatri SG, Madan KA, Srinivasan SR, Acharya S. Retention of moisture-tolerant fluoride-releasing sealant and amorphous calcium phosphate-containing sealant in 6–9-year-old children: A randomized controlled trial. J Indian Soc Pedod Prev Dent [serial online] 2019 [cited 2019 Jul 21];37:92-8. Available from: http://www.jisppd.com/text.asp?2019/37/1/92/252848
| Introduction|| |
“Fissure sealant is a material that is placed in the pits and fissures of teeth in order to prevent the development of caries.” Pits and fissures of teeth have been recognized as the most susceptible areas for initiation of caries. This may be attributed to the difficulty in maintaining oral hygiene due to the complex morphology of the pits and fissures, thus leading to retention of bacteria and food remnants. Another factor that is responsible for the high incidence of occlusal caries is the lack of salivary access into the fissures due to surface tension, preventing remineralization and thus lessening fluoride effectiveness on the occlusal surface compared to smooth surfaces. The posterior location of the permanent molars in the child's mouth also complicates its ability to properly clean these areas. Thus, sealants were introduced to seal the pits and fissures and prevent access to bacterial and food particles. Pit and fissure sealants act as a physical barrier between the tooth surface and oral environment, preventing the penetration of fermentable carbohydrates by the bacteria into the pits and fissures. The ability of the resin sealant to thoroughly fill pits, fissures, and/or morphological defects and remain completely intact and bonded to enamel surface is the primary basis for its caries prevention., Thus, sealant retention is the proxy measure of its efficacy.
The risk of developing caries is three times higher in teeth with a partially retained sealant than a completely missing sealant. Therefore, in children with high caries risk and poorer sealant retention, sealants with anticariogenic properties could be useful. These include glass ionomer sealants or resin-based sealants containing fluoride or amorphous calcium phosphate (ACP). The caries-preventive effect of glass ionomer materials is due to their ability to release fluoride. These materials are of very limited value as caries-preventive material because of the low retention rate. Fluoride-containing resin-based sealants (Embrace WetBond™) with their higher retention rates are preferred to prevent caries. Embrace WetBond™ is a moisture-tolerant resin-based sealant that can bond to the slightly moist tooth creating a leak-free interface. The oral cavity is a 100% humid environment, and without the use of rubber dam, complete isolation and moisture control is never achieved. Thus, in such conditions, moisture-tolerant sealant can prove to be advantageous.
Newer technologies such as resin-based sealant containing ACP have been recently introduced. ACP exhibits its remineralizing potential by increasing calcium and phosphate ions within the carious lesion, especially in acidic environment, to levels that exceed those existing in surrounding oral fluids, thus leading to supersaturation and formation of apatite. The abilities of these different types of sealants to prevent the development of caries as an added benefit to the obliterating property of conventional sealants have, however, not yet been compared. Hence, this study was conducted to clinically evaluate and compare the retention and development of caries on occlusal surfaces of permanent mandibular first molars in 6–9-year-old children when sealed with moisture-tolerant resin-based (Embrace WetBond™) and ACP-containing (Aegis™) sealants over a period of 1 year.
| Methods|| |
The present study was carried out on 34 schoolchildren aged between 6 and 9 years recruited from randomly selected schools in Udupi taluk, India. The permission to conduct the study was obtained from the Ethics Committee of Kasturba Medical College, Manipal (IEC 406/2011). Parents received detailed information about the study and signed informed consent forms permitting their child to participate in the trial.
This was a double-blind, split-mouth, randomized controlled trial conducted from December 2011 to March 2013. All children aged 6–9 years from selected schools were screened for inclusion and exclusion criteria by the principal investigator (PI). Children with a pair of contralateral permanent mandibular first molars with deep fissures, free of any caries as diagnosed by visual and tactile method, and teeth that were fully erupted in the oral cavity were included in the study. Exclusion criteria were teeth with restorations, cavitations, hypoplasia, and developmental defects; children with physical and mental disorders, gross orofacial defects, history of allergy to latex or resin; and uncooperative children. The sample size was calculated to be 31 children based on alpha error of 0.05, power at 80%, and expected difference in retention in both groups assumed to be 20% at the end of 1 year. Thus, 34 children (68 teeth) were selected to take into account a 10% loss to follow-up. With the approval of the school authorities and parents, children were brought to the nearest dental outreach center where sealant application was carried out.
Application of sealant
Pit and fissure sealants were applied by the PI (KS). In each child, coin toss method was used to select the type of sealant to be applied first. Furthermore, in each child, application of sealant on the right or left side was determined by lottery method. It was ensured by the PI that patients did not know the allocation by wrapping the sealants with a white paper. Isolation was achieved using cotton rolls and high-volume suction. Before the commencement of sealant application, thorough oral prophylaxis was carried out. Pits and fissures were cleaned using an explorer followed by rinsing with water from an air–water spray to remove any traces of debris adhering to the pits and fissures.
In Group 1, the occlusal surface of the teeth was etched with 37% phosphoric acid gel for 20 s and then washed and dried carefully using clean compressed air to obtain a dull, chalky-white enamel surface and sealed with Aegis™ (Bosworth Company) pit and fissure sealant. The sealant was light cured for 20 s using visible light cure unit (Smartlite PS, Dentsply).
In Group 2, teeth were sealed with moisture-tolerant resin-based sealant (Embrace Wetbond™ Sealant [Pulpdent Corporation, MA, USA]) following the manufacturer's instructions. The occlusal surface was dried using compressed air followed by acid etching with 37% phosphoric acid gel for 20 s (Total Etch, Ivoclar Vivadent, Schaan, Liechtenstein). The tooth was then irrigated vigorously with water for about 30 s. Excess moisture was removed from the tooth surface using cotton pellets, but was not desiccated to keep the tooth surface slightly moist, glossy, or shiny. Embrace Wetbond™ sealant was applied to the pits and fissures with a small applicator tip attached to the syringe. The sealant was then light cured for 20 s using visible light cure unit (Smartlite PS, Dentsply, Pennsylvania, USA). The sealants were inspected visually and tactually for complete coverage and absence of voids or bubbles. Evaluation of occlusion was performed using articulating paper, and adjustments, if required, were performed using a round- or pear-shaped composite finishing bur in the high-speed handpiece.
The follow-up examinations were conducted at 3, 6, and 12 months for evaluating the retention and development of caries by a second investigator (SI) (SR). Sealants were assessed according to a modified version of the Colour, Coverage, Caries (CCC) Sealant Evaluation System, as shown in [Table 1]. It was done by the SI (SR) who was blinded to the type of sealant used in the right or left permanent molars in all cases. This examiner received training and calibration in the evaluation of the retention of fissure sealants and caries diagnosis at the D1 (clinically detectable cavitated and noncavitated enamel lesions) and D3 (both open and closed clinically detectable lesions in dentine) diagnostic thresholds from an experienced epidemiologist (AS). Kappa coefficient for intraexaminer reliability was calculated by re-examination of six participants (18%) by the SI on successive days, and the kappa value for sealant retention was 0.78.
|Table 1: Summary of the Modified Colour, Coverage, Caries Sealant Evaluation System criteria|
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All the data in this study were categorical and therefore nonparametric statistics were performed using SPSS software version 16 (SPSS Inc., Chicago). Within-group comparison of retention and development of caries at 3, 6, and 12 months was evaluated using the Friedman's test. Wilcoxon signed-rank test was used for intergroup comparison of retention and development of caries at 3, 6, and 12 months.
| Results|| |
Of the 34 participants recruited in this study, 18 were male and 16 were female. The mean age of participants was 7.5 years (range: 6–9 years) [Figure 1]. Sixty-eight lower first permanent molars in 34 children were sealed at the start of the trial. Two children dropped out of the study, as they left school before the 6th month evaluation. Hence, the final sample consisted of 32 children with 64 teeth.
|Figure 1: Flow diagram of the progress through the phases of randomized controlled trial|
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Of the total number of sealants, complete retention (score A) was found in 26/32 (81%) teeth in Group 1 (Aegis™) and 25/32 (78.1%) teeth in Group 2 (Embrace Wetbond™) at the end of 3 months. At 6 months, Group 1 showed complete sealant retention in 25/32 (78%) teeth, whereas Group 2 showed complete retention in 23/32 (71.9%) teeth. At the end of 12 months, 23/32 (71.9%) sealants were completely retained in Group 1, whereas, in Group 2, only 21/32 (65.6%) were completely retained. Relatively, Aegis™ sealant exhibited higher retention as compared to Embrace Wetbond™ at 3, 6, and 12 months of follow-up, but was not statistically significantly different (P > 0.01). Results of Freidman's test showed that the overall probability of complete retention decreased significantly across time, i.e., 3, 6, and 12 months for both Aegis™ (P < 0.05) and Embrace Wetbond™ (P < 0.01) groups [Table 2].
|Table 2: Retention rates of Aegis and Embrace Wetbond pit and fissure sealants at 3, 6, and 12 months|
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Results for caries scores at 3, 6, and 12 months are summarized in [Table 3]. At 6 months of follow-up, only one tooth developed initial caries in Aegis™ group, whereas four teeth developed initial caries in Embrace Wetbond™ group. No statistically significant difference in caries scores was found between Aegis™ and Embrace Wetbond™ sealants at 3 and 6 months (P > 0.05). At 12 months of follow-up, only two teeth developed caries in the Aegis™ group, whereas seven teeth developed caries (three initial and four enamel caries) in the Embrace Wetbond™ group. There was a statistically significant difference in the retention rates of Embrace Wetbond™ and Helioseal™ sealants at 12 months (P < 0.05). Results of Freidman's test showed that the overall probability of caries increased significantly across time, i.e., 3, 6, and 12 months for Embrace Wetbond™ sealant (P < 0.01), whereas it was not significant for Aegis™ sealant (P > 0.05).
|Table 3: Caries scores of Aegis and Embrace Wetbond pit and fissure sealants at 3, 6, and 12 months|
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| Discussion|| |
Good oral health is an indispensible component of good general health. Healthy teeth are important for maintaining good oral health, but because of the active and uncontrolled dental caries, many children suffer from poor oral and general health. Among the caries-preventive treatments available today, pit and fissure sealants are considered as an effective, noninvasive treatment to prevent or arrest occlusal caries. Sealants form a barrier that prevents nutrients from the oral cavity reaching the microorganisms present in the fissures; this is the basis for the caries-preventive effect of sealants. The effectiveness of sealants as caries-preventive agents mainly depends on the proper bonding of the sealant to the tooth surface and its complete retention on the tooth. The occurrence of secondary dental caries due to microleakage between tooth surface and sealant is a major disadvantage of these materials. Thus, materials with remineralization potential are needed to prevent microleakage and secondary caries. The ability of a material to remineralize depends on its potential to release fluoride or calcium and phosphate in the surrounding oral fluids. Thus, in the present study, teeth were divided into two groups and randomly selected for ACP-containing (Aegis™) and fluoride-releasing moisture-tolerant (Embrace Wetbond™) sealants; both materials with the potential to remineralize and prevent caries. Six- to 9-year-old children were chosen as participants in the present study, as permanent molars are at high risk of caries 2–4 years after eruption.
In the present study, cleaning of the pits and fissures was carried out by gently running an explorer, followed by forceful rinsing with water. Donnan and Ball reported an acceptable retention of 97% when using an explorer and air–water spray, which demonstrated this as an acceptable and effective method of tooth cleaning compared with methods using handpiece and pumice. Although an evidence-based clinical recommendation did not address tooth surface cleaning methods, another review reported that all of the sealant manufacturers' instruction recommend cleaning the tooth surface before etching.
Etching was carried out for 20 s using 37% phosphoric acid in our study in accordance with the UK national guidelines. Two split-mouth randomized trials found no statistically significant difference in retention of sealants after 24 months, with or without adhesive use., Thus, sealants were applied directly on the etched surface without the use of adhesive in the present study.
Polymerization is known to be a crucial step that affects sealant retention. In this study, a single-LED light-curing unit with an intensity >300 mW/cm2 for 20 s was used to cure the sealants in both the study groups. A uniform, standardized procedure of sealant application as per the manufacturer's specific instructions was followed for both the sealants so as to reduce confounding variables and to assess the retention for different sealant materials. Modified CCC sealant evaluation system has shown substantial agreement for the assessment of sealant coverage and caries diagnosis at D1 and D3 thresholds. Thus, it was used to evaluate sealant coverage and development of caries in the present study.
In the present study, at the final evaluation (12 months), higher retention was found with Aegis™ pit and fissure sealant compared with the Embrace™ sealant; however, the difference was not statistically significant. Aegis™ sealant exhibited 72% total retention, whereas with Embrace™, 65.6% were totally retained. Our results were in concordance with the results of Kishor et al. In their study, the retention rate of Aegis was found to be 76% when compared to Delton, which showed a 74% retention rate at the end of 1 year. In a study by Bhat et al., Embrace sealant was compared with the conventional fissure sealant with bonding agent (Delton FS sealant), without bonding agent (Clinpro sealant) and glass ionomer cement. At the end of 12 months, 80.3% of sealants were completely retained in Embrace sealant group, whereas conventional fissure sealant without bonding agent exhibited complete retention in 72.4% of teeth. The findings of the present study were in contrast to the study done by Schlueter et al. that showed 93% complete retention in Helioseal sealants, while only 27% of Embrace sealants were completely retained. The oral cavity is a 100% humid environment, and without the use of rubber dam isolation, some amount of moisture may have been retained on the fissure surfaces, further affecting the bond between the sealant and tooth surface. Embrace Wetbond sealant is moisture tolerant and binds well to enamel in the presence of moisture, which could have improved the retention rate in the present study.
The effectiveness of pit and fissure sealants depends on their ability to prevent caries. In the current study, significantly lower caries scores were found in Aegis sealant as compared to the Embrace sealant at 12-month follow-up. This can be attributed to the ACP present in Aegis, which is thought to be a precursor in the formation of hydroxyapatite. ACP has certain advantages as compared to fluoride-releasing materials as follows: (1) the depth of penetration and amount of mineral deposition into the lesion is more for the ACP-containing materials than their fluoridated counterparts; (2) remineralization potential of fluoride depends on the calcium and phosphate availability in the surrounding oral fluids, ACP itself is a source of calcium and phosphate needed for hydroxyapatite formation;, and (3) ACP-containing materials are known as “active smart materials” because release of calcium and phosphate from ACP-containing materials into the surrounding oral environment occurs below pH 5.5 and ceases when pH rises above 5.5, thus has a long-lasting effect. Release of fluoride from fluoride-containing materials occurs at pH below 5.5, but it continues to release fluoride even when pH rises above 5.5. Therefore, fluoride-containing materials do not have long-lasting fluoride release and are known as “passive smart materials.”
The present study had a follow-up period of 12 months for the evaluation of the retention rates and caries scores of sealants. Dennison et al. reported that the highest period of sealant failure occurs at baseline and at 6 months following sealant application. This finding is in accordance with our study, as most of the sealants evaluated as partially or completely missing at the end of the study were also evaluated as partially or completely lost at the end of 6 months.
The study design was split mouth in which both types of materials were used in the same patient, one on each side of the mouth. This method has the advantage that it controls for patient factors such as patient behaviors, oral hygiene, diet, and other habits that may affect sealant retention and caries rates within an individual and is a strength of the study. Blinding was ensured throughout the study because PI carried out the sealant application and SI who evaluated the sealant retention and development of caries was unaware of the group assignments, thus minimizing the ascertainment bias. Limitations of the study include a comparatively limited follow-up span of 1 year for the evaluation of caries development. It can be argued that evaluation of caries progression in such short span might not be possible. A limited time frame available to conduct this study was the reason for the use of such a follow-up span.
| Conclusion|| |
Based on the findings, from this investigation, the following conclusions can be drawn:
- Moisture-tolerant fluoride-releasing sealant was less effective as compared to sealant containing ACP in terms of retention using cotton roll and high-speed suction isolation
- Caries-preventive effect of ACP-containing sealant was higher as compared to that of the moisture-tolerant fluoride-releasing sealant.
The authors wish to thank school authorities and parents of the participated children for giving permission to conduct the study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]