| Abstract|| |
Background and Aims:The aim of this study is to evaluate the clinical efficacy of pit and fissure sealants (PFS) placed on young permanent teeth with or without the application of the bonding agent. Methods:Atotal of 100 permanent first molars from 25 children between 6-9 years of age were included and randomly allocated into 2 groups. In group A, the teeth received sealant with the bonding agent, and in group B, without a bonding agent. All the sealed teeth were evaluated for retention of the sealant at regular intervals of 3, 6, and 12 months. The difference in the retention rate with and without bonding was analyzed using Chi-square test. Results:After 12 months, the clinically acceptable retention rates for PFS placed with and without bonding agent were 80% and 72%, respectively. No statistically significant difference was observed in relation to marginal integrity, marginal discoloration, and anatomic form among the PFS placed with and without bonding agent (P > 0.05). Conclusions:Sealant application with bonding agent showed an increased retention rate than without the use of a bonding agent. However, an additional step of bonding may be excluded in children, as it did not show any statistically significant difference in clinical retention rate compared to PFS application without bonding.
Keywords: Bonding agent, permanent molars, pit and fissure sealants, retention
|How to cite this article:|
Bandi M, Mallineni SK, Nuvvula S. Retention and effectiveness of pit and fissure sealants placed with or without bonding agent in young permanent teeth: A randomized clinical trial with a year follow-up. Indian J Dent Res 2020;31:877-82
|How to cite this URL:|
Bandi M, Mallineni SK, Nuvvula S. Retention and effectiveness of pit and fissure sealants placed with or without bonding agent in young permanent teeth: A randomized clinical trial with a year follow-up. Indian J Dent Res [serial online] 2020 [cited 2022 Jan 25];31:877-82. Available from: https://www.ijdr.in/text.asp?2020/31/6/877/311664
| Introduction|| |
Pit and fissure sealants (PFS) are one of the most effective non-invasive approaches to prevent and/or arrest occlusal caries in high caries risk children and in deep, retentive pits and fissures (PF). They are widely accepted in pediatric dentistry. Preservation of healthy tooth structure and prevention of dental caries is an essential measure of pediatric dentistry. Permanent molars with complicated occlusal morphology which are highly susceptible to dental caries are least protected by fluoride application. Hence, PFS is the important measure to protect the occlusal pits and fissures. Since pit and fissure sealants were introduced and based on the pioneering studies reported by Buonocore on acid etching, which improved the adhesion of resin materials to tooth structure.
The pit and fissure sealants serve by the adherence of the resin material to the acid-etched enamel surface, thus, physically occluding the pits and fissures from the rest of the oral environment. However, PFS is technique sensitive. Furthermore, the failure of retention of the resin-based fissure sealants over a period of time may be due to the breakdown of the bond between the tooth and sealant.,
Several studies have reported an increased retention rate,, and reduced effect of salivary contamination on the microleakage with the application of bonding agent. Few studies showed no effect of improved retention rate with the use of bonding agent before sealant.,,,, Hence, the present study was planned to evaluate and compare the clinical effectiveness of PFS placed with and without the use of bonding agent in permanent first molars over a period of one year. The null hypothesis is that there is no difference in the clinical effectiveness of sealants placed with and without the use of bonding agent in permanent first molars.
| Methods|| |
This prospective randomized clinical trial was carried out in the Department of Paedodontics and Preventive Dentistry, during the period of 12 months after obtaining ethical clearance from the institutional ethical committee (institutional review board) to conduct the clinical trial (D148407049).
Informed consent was obtained from parents and the concerned school authorities prior to the start of the study. One hundred permanent first molars from 25 children between the age group of 6-9 years were chosen for the sealant application based on the following inclusion and exclusion criteria:
- Children that are indicated for sealants in all four permanent first molars (PFM)?
- Children with fully erupted permanent first molars that allow rubber dam placement.
- Children with no clinical or radiographic evidence of proximal caries.
- Children with satisfactory oral hygiene (simplified oral hygiene index [OHI-S] score of 0.5).
- Children co-operative children with Frankl's behavior rating of 3 and 4 [Figure 1].
- Molars with developmental anomalies (hypoplasia, fluorosis), stained fissures, frank carious (cavitated) lesions or previously restored teeth.
- Molars where isolation is not possible.
All the permanent first molars of recruited children were assigned into 2 groups by a half-mouth experimental design. Group I, received sealant with a bonding agent and Group II, without a bonding agent. According to this design, PFS with bonding agent was applied on randomly assigned upper and lower permanent first molars of one side of the mouth, and PFS without bonding agent on the other side.
Group A: Sealant application was done with Clinpro™ (3M ESPE, USA) with the application of bonding agent.
Group B: Sealant application was done with Clinpro™ (3M ESPE, USA) without the application of bonding agent.
Sample size determination
Based on the previous studies, considering the retention rate as the primary outcome; the level of significance was set at 0.05 and power at 80%, a total sample size of 25 children (100 teeth) was essential. The selected children had a mean dmft index of 1.94 and a mean DI-S index of 1.05. Upon parental consent, PFS was placed on all the permanent first molars under a split-mouth experimental design.
The method of PFS application was exactly the same for both the groups except for the bonding agent. Oral prophylaxis was performed and isolation was achieved using cotton rolls. Each tooth surface was etched with 37% phosphoric acid (PRIME DENTAL PRODUCTS PVT. LTD., India) for 15 sec, rinsed thoroughly with air-water spray for 15 sec and dried for 30 sec. Etching of enamel surface was confirmed by a dull frosty-white appearance. If salivary contamination has occurred, the tooth surface was further re-etched. The bonding agent was applied using disposable micro-applicator tips and cured for 15 sec (group I). Sealants were applied on the permanent first molars and photo-polymerized for 20 sec. A probe was used to remove the air bubbles and ensure the flow of sealant into all pits and fissures. Explorer is passed along the margins to ensure complete application of the sealant. A single operator performed the sealant application in the allocated tooth during the same visit. The children were instructed not to eat or drink anything for 30 min. Oral hygiene instructions were also explained to the children and their parents.
Follow up examination and evaluation of the PFS was performed by a second researcher who was blinded to the study groups. Intra-examiner reliability was assessed by a re-evaluation of 10% of the patients after 10 days interval. All the children were evaluated for sealant retention at regular intervals of 3, 6, and 12 months using Simonsen's criteria [Figure 2]. Oral hygiene instructions were reinforced in each follow-up visit. However, PFS was not reapplied if they had been lost between the follow-up evaluations.
The data collected were tabulated and subjected to statistical analysis using the SPSS statistical package (version 17) with the level of significance set at 0.05. The difference in the retention rate with and without bonding was analyzed using Chi-square test.
| Results|| |
A total of 148 teeth from 37 children were assessed for eligibility, out of which 100 permanent first molars from 25 children irrespective of gender were included in the study. The total number of teeth assessed for eligibility, recruitment, randomization, allocation, and evaluation was represented in the CONSORT flow diagram [Figure 3].
Out of the 25 children, 52% were males and females being 48%, with the majority of them around 8 years old (44%). Distribution of the children according to age and gender were summarized [Table 1]. In Group A and B (with and without bonding agent), 50 teeth were examined at 3 months, 48 teeth at 6 months, and 46 teeth, respectively. Loss of sample at 6 and 12 intervals was due to migration to other places. After 12 months, the clinically acceptable retention rates for PFS placed with and without bonding agent were 80% and 72% respectively.
|Table 1: Demographic data: Distribution of children according to age and gender|
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The results of the marginal integrity of the sealants placed in Group A and B at 3, 6, and 12. The clinically acceptable marginal integrity rates for sealants with bonding agent at 3, 6, and 12 were 86%, 73%, and 67% respectively. For sealants without a bonding agent, the clinically acceptable marginal integrity rates at 3, 6, and 12 months were 74%, 65%, and 57%, respectively [Table 2]. The rates for color change (marginal discoloration) in sealants with a bonding agent, at 3, 6, and 12 were 96%, 92%, and 80% respectively. For the sealants without a bonding agent, the color change rates were 94%, 79%, and 72% respectively [Table 3]. The anatomic form of the sealants in Group A and B is represented in [Table 4]. The retention of the anatomic form of sealants with a bonding agent, after 3, 6, and 12 months were 86%, 67%, and 61%, respectively. For the sealants without a bonding agent, the retention of anatomic form was 72%, 60%, and 56%, respectively. There was no statistically significant difference among the sealants in Group A and B evaluated in relation to marginal integrity (P = 0.315), marginal discoloration (P = 0.836), and anatomic form (P = 0.689) after 12 months.
|Table 2: Comparison of marginal integrity of the sealants in patients with newly-erupted permanent molars 3-, 6-, and 12- months after treatment with and without bond agents|
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|Table 3: Comparison of discoloration of the sealants in patients with newly-erupted permanent molars 3-, 6-, and 12- months after treatment with and without bond agents|
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|Table 4: Comparison of the anatomic form of the sealants in patients with newly-erupted permanent molars 3-, 6-, and 12- months after treatment with and without bond agents|
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| Discussion|| |
Pits and fissure sealants are effective in preventing dental caries.,,,, Nevertheless, the retention of the PFS is related to the micromechanical process established by resin tag formation. Furthermore, Eidelman and co-workers considered a short etching time of 20 seconds. It has been reported that different periods of etching time 15, 30, 45 and 60 seconds doesn't influence the retention rate of sealants used on the permanent first molars. However, 37% phosphoric acid with an etching time of 15 seconds was used in the present study. The etched enamel surface was not completely air dried as it hampers the resin tag formation due to collapse and denaturation of collagen fibrils forming amorphous material.
Bonding agent forms an intermediate layer between etched enamel and the sealant, as well as increases the retention of the sealants to pits and fissures. Application of bonding agent allows optimal infiltration and formation of longer resin tags which provide micro-mechanical retention to the sealant. The retention of the anatomic form of sealants with and without bonding agent was 80% and 72%, respectively. Although some studies have reported improved bond strength with adhesive systems, increased sealant retention on saliva contaminated teeth,, and minimized micro-leakage,,, with the use of adhesive systems, whereas others have shown a decrease in the bond strength, stating that the primers get diluted by moisture., Nonetheless, few studies reported no benefit of increased retention rate by using a bonding agent before sealant application,,,, which is consistent with the results of our study. In cases where saliva contamination is inevitable, the use of a bonding agent under sealant is recommended to improve retention and reduce the micro-leakage.,, Cehreli and Gungor found that sealants placed without the use of a bonding agent showed the greatest amount of leakage after four years. Adsorption of glycoproteins to the poorly polymerized adhesive surface might act as a barrier that prevents complete wetting of resin-based sealant and thus prevents adequate copolymerization. In the present study, both the groups with and without bonding, in which isolation was performed with cotton rolls, could have led to saliva contamination of bonded surface even after careful isolation. This might be the possible reason for the high failure rate observed in the group with and without a bonding agent.
Patil and co-workers reported that when a cured adhesive layer is contaminated with saliva, rinsing of the surface with water did not improve the detrimental effects of saliva contamination. The long-term effects of saliva contamination are not clear. However, it was believed that contamination might cause nano-leakage within the hybrid layer. However, failure rates in both bonded and non-bonded groups are relatively high. Failure of sealants that occur initially, during the first six months of the application indicates improper technique., Failures that occur secondarily, beyond a period of 6 months, may be due to a decrease in the bond strength with the progression of time, long-term exposure to saliva or acidic beverages or thermal variations. Furthermore, saliva contamination of the etched enamel surface before sealant placement is the most common reason for sealant failure,, either in the bonded or non-bonded groups. Saliva contamination generally causes adhesive bond failures, fracturing at the enamel-resin interface. The uncontaminated samples most frequently had cohesive bond failures, occurring within the resin itself, leaving the bond intact. Accordingly, the long-term clinical success of fissure sealants is closely related to proper moisture control at each step of application., Moreover, the failure rates were observed to be relatively high in both groups. The possible reasons for such high failure rates include patient behavior, saliva control, enamel alterations, patient age, time of placement and maxillary or mandibular arch. However, behavior and moisture control was considered as the essential factors which influence sealant effectiveness. Indeed, a patient with poor behavior cannot be well managed and it is difficult to achieve proper moisture control. As the procedure is technique sensitive, inadvertent salivary contamination even after careful isolation, and co-operation of the children during the procedure were considered as limitations of the present study.
| Conclusion|| |
Sealants with bonding agent showed promising retention than that of sealants placed without bonding. Nonetheless, the results were not statistically significant. In case of marginal integrity, discoloration and the anatomic form were more adequate in sealants placed with bonding agent than without bonding.
We thank all the children and their parents for their participation in this study.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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Dr. Sreekanth K Mallineni
Associate Professor, Pediatric Dentistry, Department of Preventive Dental Science, College of Dentistry, Majmaah University, Majmaah , 11952.
Source of Support: None, Conflict of Interest: None
[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]