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Table of Contents   
ORIGINAL ARTICLE  
Year : 2015  |  Volume : 18  |  Issue : 1  |  Page : 20-24
A randomized control clinical trial of fissure sealant retention: Self etch adhesive versus total etch adhesive


1 Department of Operative Dentistry, Foundation University Dental College, Islamabad, Pakistan
2 Department of Operative Dentistry, Dental Section, Department of Surgery, Aga Khan University Hospital, Karachi, Pakistan
3 Department of Operative Dentistry, Margalla Institute of Health Sciences, Rawalpindi, Pakistan

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Date of Submission24-Jul-2014
Date of Decision23-Sep-2014
Date of Acceptance04-Oct-2014
Date of Web Publication8-Jan-2015
 

   Abstract 

Context: There are limited studies on comparison of Total etch (TE) and Self etch (SE) adhesive for placement of sealants.
Aims: The aim of the study was to compare the retention of fissure sealants placed using TE adhesive to those sealants placed using SE (seventh generation) adhesive.
Settings and Design: The study was conducted in the dental section, Aga Khan University Hospital. This study was a randomized single blinded trial with a split mouth design.
Materials and Methods: The study included 37 patients, 101 teeth were included in both study groups. The intervention arm was treated with SE Adhesive (Adper Easy One, 3M ESPE, US). Control arm received TE adhesive (Adper Single Bond 2, 3M ESPE, US) before sealant application. The patients were followed after 6 months for assessment of sealant retention.
Statistical analysis used: Interexaminer agreement for outcome assessment was assessed by Kappa Statistics and outcome in intervention group was assessed by McNemar's test.
Results: Ninety-one pairs of molar (90%) were reevaluated for sealant retention. Complete retention was 56% in TE arm and 28% in SE arm with an odds ratio (OR) of 3.7.
Conclusions: Sealants applied with TE adhesives show higher rate of complete sealant retention than SE adhesive.

Keywords: Dental sealants; dentin bonding agent; fissure sealants; one-step dentin bonding system; pit and fissure sealants

How to cite this article:
Aman N, Khan FR, Salim A, Farid H. A randomized control clinical trial of fissure sealant retention: Self etch adhesive versus total etch adhesive. J Conserv Dent 2015;18:20-4

How to cite this URL:
Aman N, Khan FR, Salim A, Farid H. A randomized control clinical trial of fissure sealant retention: Self etch adhesive versus total etch adhesive. J Conserv Dent [serial online] 2015 [cited 2019 Jul 22];18:20-4. Available from: http://www.jcd.org.in/text.asp?2015/18/1/20/148883

   Introduction Top


Pits and fissures are reported to be involved in almost 90% of carious lesion of permanent posterior teeth. [1] Pit and fissure sealant has been considered as a highly effective caries preventive treatment and are widely recommended and used in dentistry today. In a systematic review, Griffin. [2] has reported a reduction of 9% in median annual caries progression after sealant application.

Pit and fissure sealants have been placed with and without use of adhesive. [1] It has been demonstrated that use of adhesive before sealant placement on enamel surface contaminated with moisture, may help in reducing microleakage. [3] Clinical study by Feigal. [4] has reported improvement in the retention of sealants with application of adhesives before sealant placement.

The sixth and seventh generation adhesives have introduced lesser steps for applications hence are less technique sensitive than TE adhesive. [5] There is limited literature available on effectiveness of the SE adhesives in retention of fissure sealants. [6] Feigal and Quelhas. [7] reported equivocal results with use of SE adhesives and TE adhesives before sealant application, but their study was limited by smaller sample size. Similar study was conducted by Burbridge. [8] whereas study by Venker et al. [9] was retrospective review of fissure sealant program in a school.

The seventh generation SE adhesives are based on single bottles system where etching, priming and bonding occurs in single step. The reduction in number of steps can lead to lesser chances of procedural errors, lesser chair side time and result in more patient comfort during placement of fissure sealants. [6] The aim of the current study was to compare the retention of resin based sealants placed with application of Total Etch (TE) and Self Etch (SE, seventh generation) adhesive in permanent molar teeth, at 6 months follow-up.


   Subjects and methods Top


Study setting and design

The study was conducted at Dental section of a tertiary care hospital. The study was single blind randomized control trial; assessors were blinded to treatment allocation. Split mouth design was used for provision of treatment; the left and right molar tooth of same patient was used for study.

Eligibility criteria

The subjects included in study were of age 6-16 years, with previously untreated fully erupted first or second molar having intact contralateral molar (molar pair). The occlusal fissures of maxillary or mandibular permanent molar with functional occlusion were selected for study. Subjects who on visual inspection had deep occlusal fissures (prone for food entrapment) or high caries risk (history of previous fillings and caries in other teeth, or currently undergoing orthodontic treatment) were included in study. Patients with parafunctional habits, uncooperative patients and mentally challenged or physically handicapped subjects were excluded from study.

Calibration of clinicians and assessors

The fissure sealants were applied by two clinicians with similar years of clinical experience. Both clinicians received training for clinical procedures for sealant placement with both adhesive to minimize variation in treatment protocol. Outcome assessment was done by two independent assessors. These assessors were practicing clinicians with similar years of clinical experience. Both assessors were calibrated for assessment of sealant retention of treated teeth before commencement of trial. The inter examiner agreement for sealant retention by the two assessors was assessed on 10 % (10 teeth) of sample. The kappa coefficient was of 0.82 which shows good inter examiner agreement for sealant assessment by the assessors.

Randomization

Simple randomization of treatment allocation was carried out using computer generated random number for treatment assignment of right molar tooth. The left molar received the alternate treatment. The random number sequence was generated by statistician of Community Health Sciences department. The random number generated was only disclosed to treating clinician before sealant placement procedure.

Ethics

Ethical Review committee approval was obtained prior to initiation of the trial (id no 915-Surg/ERC-08). After patients agreement for participation a written informed consent was obtained. Consent was taken from parents of subjects on a standardized form approved by Ethics Review Committee; a copy of consent form was given to participants as well.

Treatment protocol of control and intervention arm

In control arm (TE adhesive) the selected tooth received prophylaxis with brushes for 10-15 seconds using a slow speed hand piece. Isolation was achieved with cotton rolls. The occlusal fissures were treated with 37% phosphoric acid (Total Etch Ivoclar Vivadent, Switzerland) for 15 seconds followed by rinsing for 30 seconds and then drying with air syringe. Adper Single Bond 2 (3M ESPE, US) was applied to occlusal fissure using microbrushes. After application the adhesive was light cured (ColtoLux by Coltene Whaledent, Switzerland) for 10 seconds. After curing of the adhesive, opaque fissure sealant material (Clinpro by 3M ESPE, US) was applied and light cured for 20 seconds.

In the intervention arm (SE adhesive) similar steps for prophylaxis and isolation was done as in control arm. SE adhesive (Adper Easy One, 3M ESPE, US) was applied to occlusal fissures with microbrushes and was rubbed on fissure surface with microbrush for 20 seconds. This was followed by air drying for 10-15 seconds followed by light curing for 10 seconds. Sealant was applied (Clinpro 3M ESPE, US) in a similar manner as for control group.

Outcome assessment & blinding

Primary outcome was complete sealant retention that was assessed at 6 months follow-up of treated patients. Patients were given reminder for follow-up visit on completion of 6 months after initial sealant application. The patient was considered a drop out if the patient did not return for assessment. The outcome was assessed by visual inspection of the treated occlusal surface of the tooth surface as an opaque sealant was used with contrast to tooth color. The fissure sealant retention was rated by one of the two assessors. The sealant was rated as complete retention if the all the occlusal fissures were covered by sealant and as partial retention if some of occlusal fissures of a tooth showed loss of sealant. If sealant was missing from all the occlusal fissure of the tooth it was rated as complete failure. The assessors were blinded to treatment allocation as they were not given access to allocation of treatment and the adhesive used was covered by same brand of fissure sealant in both treatment groups.

Analysis

SPSS version 16 was used for analysis. For analysis partial or complete failure of sealant was grouped as failure and complete retention as success. For comparing the paired intervention and control McNemar's test was applied at 5% level of significance. Effect of gender on outcome was assessed by Phi & Crammer's V Test.


   Results Top


Out of 37 subjects recruited initially, 33 (89.2%) subjects presented for follow-up visit, four subjects were lost to follow-up. Out of 101pairs of teeth 91 pairs were available for evaluation [Figure 1].
Figure 1: Layout of fi ssure sealant retention trial. 37 subjects with 101 pairs of molar teeth were included in study

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The average age of patients was 12.7 ( ± 2.9) years, mean number of treatment pair per patient was three. Most patients (48.6%) were in age-range of 13-16 years [Figure 2]. The most common indication for sealant placement in the subjects was deep occlusal fissure in 59.5% of subjects (n = 22), whereas 15 (41.1%) subjects enrolled received treatment due to increased caries risk. Maxillary first molars were most common (30.7%) teeth included in the study [Table 1].
Figure 2: Age-group distribution of study subjects, n = 37

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Table 1: Baseline characteristics of subjects (patients n = 37, treatment pairs n = 101)

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The intervention assignment was done by randomization on the right member of the selected molar pair [Table 1]. The right member of the intervention pair received the treatment with TE adhesive was in greater proportion than SE. Statistically insignificant and weak correlation was seen between gender and treatment outcome of TE and SE (correlation coefficient 0.29 and 0.17 respectively).

The comparison of complete sealant retention in both treatment group showed significant difference (P-value < 0.001) [Table 2] where a higher proportion of complete retention was seen in TE arm. The Odds ratio for complete retention of sealants on follow up was 3.7 for TE compared to SE.
Table 2: Comparison of sealant retention in control and intervention treatment pairs (n = 91)

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   Discussion Top


Resin based pit and fissure sealant is an effective method of caries prevention in dentistry. [10] The applications of bonding agents are believed to enhance retention of pit and fissure sealants. According to evidence based recommendation for pit and fissure sealants. [1] utility of Self etch adhesives for sealant application and retention of light cured fissures sealants have been identified as a potential research area for generation of more evidence. There are few published clinical studies on use of SE and TE adhesive for placement of fissure sealants. So far only two clinical trials have been published comparing sixth generation SE and TE adhesives. [7],[8],[11] Only one prior study has been conducted on use of seventh generation SE adhesive for sealant placement by Das. [12] The study was non randomized clinical study on comparison of sealants applied with and without use of seventh generation adhesive.

Current study reported a retention rate of retention of 58% for TE treated sealant and 28.6% for SE treated sealants. Systematic review. [13] on the complete retention of light cured resin based sealants has been reported between 57-96% at 6 months after sealant placement. Study by Das. [12] compared seventh generation adhesive (I Bond by Heraseus Kulzer) for sealants application versus sealants placed without adhesive. A higher retention rate of 83% at 6 months follow-up in sealants placed with SE adhesive was reported in this study compared to 28.6% in our study. Difference in outcome can also be attributed to difference in brand of Seventh generation adhesive as its bonding ability can vary with its acidic PH.

Other clinical studies have compared sixth generation SE adhesive to TE adhesive. Clinical trial by Feigel. [7] reported similar retention rates of 61% for SE adhesives at 24 months which are comparable for TE. Study by Burbridge. [8] reported retention proportion of 36.6% for TE and 0% complete retention in SE treated sealants on 6 months follow-up where as Venker. [14] reported that SE were 6 times more likely to fail than TE, whereas current study showed odds ratio of 3.7 for failure in SE compared to TE. The difference in the odds ratio can be attributed to the difference in the duration of follow-up of both studies and difference in study design (a clinical trial versus retrospective comparison).

The poor sealant retention in SE adhesive compared to TE can be attributed to its lesser ability to penetrate the enamel surface which may result in lesser bond strengths compared to TE which has been shown in in vitro study. [15] On contrary two in vitro studies. [16],[17] reported higher bond strengths for sealants placed with sixth generation SE adhesive. The variation in bond strengths can be attributed to use of different SE adhesives with varying PH from one brand to other.

Important limitation of the study was the use of a single brand of TE and SE, as the pH of the adhesive varies from brand to brand and the retention is known to be higher in the more acidic adhesives due to increased depth of penetration of acidic adhesives. [18]

The major limitations of the study design were due to the split mouth design. The split mouth design resulted may have resulted restriction in recruitment. [19],[20] and may have led to selection bias by inclusion of subjects 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. The split mouth design resulted in overmatching of factors that did not allow the study of effects of other variables that can influence the sealant retention other than intervention.

In current study TE adhesive placement before sealant application resulted in greater proportion of complete sealant retention in occlusal fissure of permanent teeth than SE adhesive application. Within limitations of this study it is recommended that if adhesives are to be used before sealant placement then the use of TE adhesive will provide higher rate of complete sealant retention than SE adhesives. Further studies are needed for assessment of the effect of pH of Self etch adhesives on sealant retention.


   Acknowledgement Top


Late Dr Ali Khan Khuwaja, and Dr Khabir Ahmed for their support and guidance. Author is grateful to Syed Iqbal Azam for his mentoring of data analysis

 
   References Top

1.
Beauchamp J, Caufield PW, Crall JJ, Donly K, Feigal R, Gooch B, et al. Evidence-based clinical recommendations for the use of pit-and-fissure sealants: A report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc 2008;139:257-68.  Back to cited text no. 1
    
2.
Griffin SO, Oong E, Kohn W, Vidakovic B, Gooch BF; CDC Dental Sealant Systematic Review Work Group, Bader J, et al. The effectiveness of sealants in managing caries lesions. J Dent Res 2008; 87:169-74.  Back to cited text no. 2
    
3.
Borsatto MC, Corona SA, Alves AG, Chimello DT, Catirse AB, Palma-Dibb RG. Influence of salivary contamination on marginal microleakage of pit and fissure sealants. Am J Dent 2004;17:365-7.  Back to cited text no. 3
    
4.
Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: A clinical study of two-bottle and single-bottle systems. J Dent Res 2000;79:1850-6.  Back to cited text no. 4
    
5.
Perdigao J, Frankenberger R, Rosa BT, Breschi L. New trends in dentin/enamel adhesion. Am J Dent 2000;13:25D-30D.  Back to cited text no. 5
    
6.
Das UM, G S. Bonding agents in pit and fissure sealants: A Review. Int J Clin Paediatr Dent 2009;2:1-6.  Back to cited text no. 6
    
7.
Feigal RJ, Quelhas I. Clinical trial of a self-etching adhesive for sealant application: Success at 24 months with Prompt L-Pop. Am J Dent 2003;16:249-51.  Back to cited text no. 7
    
8.
Burbridge L, Nugent Z, Deery C. A randomized controlled trial of the effectiveness of a one-step conditioning agent in fissure sealant placement: 12 month results. Eur Arch Paediatr Dent 2007;8:49-54.  Back to cited text no. 8
    
9.
Venker DJ, Kuthy RA, Qian F, Kanellis MJ. Twelve-month sealant retention in a school-based program using a self-etching primer/adhesive. J Public Health Dent 2004;64:191-7.  Back to cited text no. 9
    
10.
Ahovuo-Saloranta A, Forss H, Walsh T, Hiiri A, Nordblad A, Mäkelä M, et al. Sealants for preventing dental decay in the permanent teeth. Cochrane database of syst Cochrane Database Syst Rev 2013;3:CD001830   Back to cited text no. 10
    
11.
Burbridge L, Nugent Z, Deery C. A randomized controlled trial of the effectiveness of a one-step conditioning agent in sealant placement: 6-month results. Int J Paediatr Dent 2006;16:424-30.  Back to cited text no. 11
    
12.
Das UM, Vishwanath D, Venkatasubramanian R, Gopal S. Retention of Pit-and-Fissure Sealants With and Without A Seventh Generation Bonding Agent: A Clinical Study. Dent Indianet 2008;2 Available from http://www.dentistryindia.net/article.php?id=1019 [last accessed on 2014 Sep 18].  Back to cited text no. 12
    
13.
Muller-Bolla M, Lupi-Pegurier L, Tardieu C, Velly AM, Antomarchi C. Retention of resin-based pit and fissure sealants: A systematic review. Community Dent Oral Epidemiol 2006;34:321-36.  Back to cited text no. 13
    
14.
Venker DJ, Kuthy RA, Qian F, Kanellis MJ. Twelve-month sealant retention in a school-based program using a self-etching primer/adhesive. J Public Health Dent 2004;64:191-7.  Back to cited text no. 14
    
15.
Erickson RL, Barkmeier WW, Latta MA. The role of etching in bonding to enamel: A comparison of self-etching and etch-and-rinse adhesive systems. Dent Mater 2009;25:1459-67.  Back to cited text no. 15
    
16.
Dhillon JK, Pathak A. Comparative evaluation of shear bond strength of three pit and fissure sealants using conventional etch or self-etching primer. J Indian Soc Pedod Prev Dent 2012;30:288-92.  Back to cited text no. 16
[PUBMED]  Medknow Journal  
17.
Al-Sarheed MA. Evaluation of shear bond strength and SEM observation of all-in-one self-etching primer used for bonding of fissure sealants. J Contemp Dent Pract 2006;7:9-16.  Back to cited text no. 17
    
18.
Gregoire G, Ahmed Y. Evaluation of the enamel etching capacity of six contemporary self-etching adhesives. J Dent 2007;35:388-97.  Back to cited text no. 18
    
19.
Lesaffre E, Philstrom B, Needleman I, Worthington H. The design and analysis of split-mouth studies: What statisticians and clinicians should know. Stat Med 2009;28:3470-82.  Back to cited text no. 19
    
20.
Hujoel PP. Design and analysis issues in split mouth clinical trials. Community Dent Oral Epidemiol 1998;26:85-6.  Back to cited text no. 20
    

Top
Correspondence Address:
Dr. Nadia Aman
Department of Operative Dentistry, Foundation University College of Dentistry, Defence housing authority1, GT road, Islamabad
Pakistan
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Source of Support: The study was supported by research grant from Aga Khan University Research Council (URC ID 07GS028SUR), Conflict of Interest: None


DOI: 10.4103/0972-0707.148883

Clinical trial registration www.trials.gov ((NCT00873990)

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