|Year : 2018 | Volume
| Issue : 4 | Page : 402-406
A 1-year appraisal of pit and fissure sealants following disinfection with and without chlorhexidine solution: An in vivo randomized trial
Vikram Pal Aggarwal1, Anmol Mathur2, Aditi Mathur3
1 Department of Public Health Dentistry, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan, India
2 Department of Public Health Dentistry, Dr. D.Y Patil Vidyapeeth, Pune, Maharashtra, India
3 Department of Pedodontics and Preventive Dentistry, Dr. D.Y Patil Vidyapeeth, Pune, Maharashtra, India
|Date of Web Publication||16-Oct-2018|
Dr. Vikram Pal Aggarwal
Department of Public Health Dentistry, Surendera Dental College and Research Institute, Sri Ganganagar, Rajasthan
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Objective: The objective of this study is to evaluate the effect of chlorhexidine on the outcome of pit and fissure sealant (PFS) in permanent molars. Methods: A double-blind randomized controlled trial using split-mouth design was conducted for a period of 1 year. The clinical trial registry was done in the Indian Council of Medical Research, and the clinical trial number obtained was CTRI/2016/08/007222. The age group of participants involved in the trial was 7–14 years. Maxillary or mandibular permanent molar which satisfies the criteria for application of PFS was included in the trial. Based on the eligibility criteria and considering the unknown observer/instrumentation errors, the sample size is 33 for each group. Simple randomization of treatment allocation was carried out using computer-generated random number for treatment assignment of the right molar tooth. The left molar received the alternative treatment. The outcomes of PFS were evaluated by a lone proficient assessor by means of the mouth mirrors and probes following the US public health service criteria. Results: A 6-month evaluation for the PFS with and without chlorhexidine showed 77.27% and 89.39% retention, respectively. PFS without chlorhexidine suffered a greater loss of surface texture and marginal discoloration in comparison to PFS with chlorhexidine at 3-, 6-, and 12-month intervals, but it was statistically insignificant. Conclusion: The present study showed improvement in outcome of PFS when an additional step of chlorhexidine is added although the results were statistically nonsignificant.
Keywords: Chlorhexidine, pit and fissure, prevention, sealant
|How to cite this article:|
Aggarwal VP, Mathur A, Mathur A. A 1-year appraisal of pit and fissure sealants following disinfection with and without chlorhexidine solution: An in vivo randomized trial. J Indian Soc Pedod Prev Dent 2018;36:402-6
|How to cite this URL:|
Aggarwal VP, Mathur A, Mathur A. A 1-year appraisal of pit and fissure sealants following disinfection with and without chlorhexidine solution: An in vivo randomized trial. J Indian Soc Pedod Prev Dent [serial online] 2018 [cited 2019 Aug 25];36:402-6. Available from: http://www.jisppd.com/text.asp?2018/36/4/402/243447
| Introduction|| |
It has been an accepted fact that deep pits and fissures (PF) lead to nearly 90% of cavities in permanent posterior teeth. Pit and fissure sealant (PFS) is widely regarded as a cavity inhibitory prophylaxis of choice in recent times.
PFS outcome depends on their retention rate and their ability to prevent microleakage around the sealant and teeth., The accepted cause for microleakage is bacterial contamination. Although acid etching does remove microorganisms from the enamel surface, in deep pits and fissures, particularly with early carious lesions, the tooth may still show various amounts of bacteria remaining even after acid etching during fissure sealant therapy. Hence, to make sure that residual bacteria have been removed, a separate antibacterial agent chlorhexidine digluconate (CHX) can be very handy as it is acknowledged as an agent with bactericidal effect. Still, there is hullabaloo regarding the outcome of CHX on the bonding capability of diverse adhesive systems, and its influence has not been assessed in fissure sealant therapy till date. Hence, there is a felt need to conduct an in vivo study to assess the consequence of chlorhexidine on the outcome of PFS in permanent molars.
| Methods|| |
The present research was a double-blind randomized controlled trial using split-mouth design conducted for a period of 1 year. The present trial was ethically approved by the Ethical Review Committee of the institute before the commencement of the trial (ID no. 915-Surg/ERC-08). The clinical trial registry was done in the Indian Council of Medical Research, and the clinical trial number obtained was CTRI/2016/08/007222. Parents who allowed their kids to participate in the study signed a consent on a standardized form. The present clinical trial conforms to the CONSORT guidelines.
Seventy-six children aged 7–14 years had participated in the study. The study was conducted at the Department of Public Health Dentistry, Surendera Dental College and Research Institute. The study participants were arbitrarily allocated to two groups, i.e., sealant with chlorhexidine in one molar (intervention arm) and sealant without chlorhexidine (control arm) in the contralateral molar. In the present study, experimental groups and investigator were blinded to treatment allocation. A split-mouth design was applied for the present trial, in which the PFS with and without chlorhexidine solution was arbitrarily placed in matched contralateral pairs of permanent molar teeth. Participants with previously untreated fully erupted first or second molar having intact contralateral molar (molar pair) which satisfies the criteria for application of PFS, the presence of at least two deep occlusal fissures (prone to food entrapment), and no prior preventive treatment were included in the trial. Patients with parafunctional habits, systemic disease, current participation in other studies, allergy to restorative materials, and uncooperative and differently abled kids were not considered for the present trial. The sample size was estimated considering the following variables:
- Minimum expected difference – 2 MPa
- Variations expected within the group – 1.2 MPa
- Cohen's δ=2/1.2 = 1.66
- Level of significance = 0.05 (5%)
- Power of the study = 1−β=1 − 0.15 = 0.85.
With this information, the minimum sample size required will be 30 in each group. Therefore, after applying eligibility criteria and considering the unknown observer/instrumentation errors, the sample size is increased to 33 for each group.
Two clinicians having the same sort of clinical experience in the application of PFS were selected. Both clinicians received training for PFS placement with and without chlorhexidine to curtail the discrepancy in the treatment procedure. The result analysis was done by two autonomous evaluators. Both evaluators were standardized for valuation of PFS retention of treated teeth before the initiation of the study. The inter-examiner agreement for PFS retention was assessed on 10% of the sample which was found to be 0.93 (kappa coefficient).
Simple randomization of teeth undergoing PFS application with and without chlorhexidine was carried out by a statistician using computer-generated random number for treatment assignment of the right molar tooth. The left molar received the alternate treatment.
In the present trial, both intervention (PFS with chlorhexidine) and control group (PFS without chlorhexidine) have undergone a similar procedure for PFS application. The procedural steps followed are (a) the chosen tooth received oral prophylaxis, i.e., scaling and polishing of the chosen tooth, (b) after scaling and polishing, the tooth was isolated with cotton rolls. Etching was done of the occlusal fissures with 37% phosphoric acid (Total Etch Ivoclar Vivadent, Switzerland) for 15 s followed by rinsing for 30 s and then drying with air syringe, (c) Adper Single Bond-2 (3M ESPE, US) was applied to occlusal fissure using microbrushes followed by light curing (Coltolux by Coltene Whaledent, Switzerland) for 10 s, (d) after curing of the adhesive, opaque fissure sealant material (Clinpro by 3M ESPE, US) was applied and light cured for 20 s. The only difference between intervention and control group was that there was an additional step of application of chlorhexidine solution to occlusal fissures with microbrushes which was followed by natural drying for 1 min after scaling, isolation, and acid etching in the intervention group. After application of chlorhexidine solution, the rest of procedure was same in the intervention arm, i.e., application of bonding agent and fissure sealant material.
The principal outcome was to assess and compare PFS retention among intervention and control groups at the end of 1-year follow-up. Participants received a call for the follow-up visit on completion of 3, 6, and 12 months, respectively, after PFS application. The participant was considered a dropout if he/she did not return for follow-up. Based on the US public health service criteria, PFS was rated by already trained and calibrated two examiners using the mouth mirrors and probes. This criterion was opted because of its (a) simplicity, (b) information can be recorded easily in a presentable form, (c) easy communication, and (d) insure coverage of all the factors that justify clinical accomplishment for the restorations. PFS assessment factors included retention, anatomical form, surface texture, and marginal discoloration. The recording was done either by designating letters (A, B, C, etc.) or algebraic numbers (0, 1, 2, etc.). Because the algebraic number was easier for statistical analysis, we have implemented the same in the current trial. For criteria such as anatomical form and marginal discoloration, we have given a score of 0 to indicate acceptability and scores of 1 and 2 to indicate progressively lessening degrees of clinical acceptance. For criteria such as surface texture, we have given a score of 0 to indicate acceptability and scores of 1 to indicate progressively lessening degrees of clinical acceptance. The retention was evaluated by visual inspection with the help of a probe and mouth mirror as advocated by Horowtiz et al. A score of 0 was given for complete retention, 1 was given for partial retention, and 2 was given for no retention.
The collected data were tabulated in an Excel Sheet. Data were analyzed using IBM SPSS Statistics Windows, version 20.0 IBM Corp., (Armonk, NY, USA) for the generation of descriptive and inferential statistics. Chi-square test was used to determine the statistically significant difference among intervention and control groups.
| Results|| |
The data were collected at three different intervals, i.e., at 3 months, 6 months, and 1 year. In the current trial, the 3- and 6-month assessment for the PFS without chlorhexidine revealed 86.36% and 77.27% retention, respectively, and 92.42% and 89.39% retention, respectively, for PFS with chlorhexidine. After the 1-year evaluation of retention among the groups, 59.09% and 87.88% of retention were among PFS without and with chlorhexidine, respectively (P < 0.05) as shown in [Table 1].
|Table 1: Comparison of retention between pit and fissure sealant with and without chlorhexidine|
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It can be well appreciated from [Table 2] that PFS without chlorhexidine suffered a greater loss of surface texture in comparison to PFS with chlorhexidine at 3-, 6-, and 12-month intervals, but it was statistically insignificant. Similar sort of result was observed when PFS without and with chlorhexidine was compared for marginal discoloration and anatomical form [Table 3] and [Table 4].
|Table 2: Assessment of marginal discoloration between pit and fissure sealant with and without chlorhexidine|
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|Table 3: Assessment of anatomical form between pit and fissure sealant with and without chlorhexidine|
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|Table 4: Assessment of surface texture between pit and fissure with and without chlorhexidine|
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| Discussion|| |
The current 12-month study assesses and compares data on the consequence of PFS application in newly erupted permanent molars in a clinical situation using split-mouth design, with and without the use of chlorhexidine.
In a developing country like India, the focus is rarely on preventive treatment. There is no doubt that fee of cavity inhibitory agents such as PFS may cost more when compared to the cost of restorative materials, but PFS is far better when compared with restorative materials in term of cost-effectiveness as the tooth would be maintained in a state of health. The maximum benefit of PFS can be only achieved when PFS should bond properly to the enamel surface because only then there should be an establishment of acceptable retention and prevention of microleakage along the interface between the tooth and the sealant. The reason for the failure of bonding has been described in the introduction part. Therefore, this in vivo study is a pioneer attempt to see whether with the addition of antimicrobial agent like chlorhexidine solution during the application of PFS will lead to improvement in term of retention and microleakage?
Marginal discolorations of a restoration were the initial signs of its loss of marginal integrity with the adjacent tooth structure. Marginal breakdown (leads to a rough and irregular surface) is the reason why a restoration discolors. There are chances that plaque and food debris may accumulate in this rough and irregular surface which encourage the penetration of oral fluids and cause microleakage. This microleakage may results in the formation of secondary caries. At baseline, all PFS were checked visually and scored no cavosurface marginal discoloration. At the end of 1-year evaluation, marginal discoloration was low among PFS with chlorhexidine as compared to PFS without chlorhexidine but statistically nonsignificant. This difference may be due to the fact that in the cases where PFS without chlorhexidine was done, they may still show various amounts of bacteria remaining even after acid etching during fissure sealant therapy, whereas in PFS cases with a separate antibacterial agent (chlorhexidine), it ensures almost complete removal of bacteria. This has been well documented by Eminkahyagil et al., 2005 and Türkün et al., 2006, that a separate antibacterial agent like CHX can be useful to prevent caries. Chlorhexidine is known to reduce caries with immediate bactericidal effect in the cavity.
Assessment of the surface texture of PFS is scarce in the literature. The surface texture is another important factor to assess the outcome of PFS, because if there is an increase in surface texture, then it acts as a niche for the accumulation of plaque and food debris, which encourage the penetration of oral fluids and cause microleakage. This microleakage may result in the formation of secondary caries. In the present study, PFS without chlorhexidine suffered a greater loss of surface texture than the PFS with chlorhexidine. This will result in rapid surface disintegration, thinning of the sealant, and ultimately fracturing it off from the enamel surface.
The success of PFS as a caries inhibitory agent depends on its complete retention. Numerous researchers, reported that the caries increment is low when there is complete retention of the PFS. In the current trial, the 3-month valuation revealed 86.36% retention for PFS without chlorhexidine and 92.42% retention for PFS with chlorhexidine. However, the 1-year valuation revealed 69.69% retention for PFS without chlorhexidine and 87.88% retention for PFS with chlorhexidine and was found to be statistically significant.
Obviously, the question rose after this study: is it essential to add an antimicrobial step to kill bacteria before PFS application? Settembrini et al., 1997 stated that the issue of bacterial entry or residual bacteria within a cavity preparation may diminish in importance, especially if the restoration is able to maintain its seal. Here is the restorative crux of the challenge. PFS might shrink during its polymerization process causing micro-leakage which leads to secondary caries. Similarly, since microleakage can occur around PFS, we have to find the ways to minimize the effects of this microleakage and possible ingress of bacteria at the junction between the cavity preparation and PFS.
The limitations of the study design were due to the split-mouth design. The split-mouth design may have resulted restriction in recruitment and may have led to selection bias by inclusion of participants who were not at as high caries risk compared to those excluded as they were less likely to have an intact unrestored pair of molar tooth to be treated.
| Conclusion|| |
The present trial was an attempt to see whether the application of antibacterial agent after acid etching will improve the result of PFS or not? The present study showed improvement in outcome of PFSs when an additional step of chlorhexidine is added although the results were statistically nonsignificant. The author recommends further such type of studies in future so that a clear hypothesis can be generated.
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]