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Table of Contents   
ORIGINAL RESEARCH  
Year : 2019  |  Volume : 30  |  Issue : 4  |  Page : 487-495
Randomized clinical trial of four adhesion strategies: A 42 month study


Department of Operative Dentistry, Postgraduate Program in Dentistry, Paulista University, São Paulo, SP, Brazil

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Date of Submission30-Jun-2016
Date of Decision06-Jun-2017
Date of Acceptance26-Sep-2017
Date of Web Publication18-Nov-2019
 

   Abstract 

Context: The adhesives clinical effectiveness has been extensively reported for noncarious cervical lesions (NCCLs). However, there is a lack of information about the adhesive systems strategies and their effect on NCCL restoration longevity. Aims: This study aims to evaluate a 42-month performance of four dentin adhesive systems used for the restorative treatment of NCCLs. Settings and Design: NCCLs were randomly divided into four groups: (1) Scotchbond multi-purpose (MP); 2: Single bond plus (SB); 3: Scotchbond SE (SE); and 4: Easy bond (EB). Subjects and Methods: NCCLs (125) were randomly distributed: (1) MP; (2) SB; (3) SE; and (4) EB and were restored with a nanofilled resin-composite, evaluated along 18-36-42 months. Statistical Analysis Used: Kruskal–Wallis test: Comparison among the adhesive systems in each period. Friedman analysis: Comparison along the periods. Kaplan–Meier: Survival analysis. Results: Baseline and 42-month retention (RET) rates (%) were 100/100 for MP; 100/94.74 for SB; 100/87.5 for SE; and 100/100 for EB. The cumulative failure percentage was 9.52% for MP, 9.52% SB, 15.8% SE, and 10% EB. Restorations survival was not dependent on the used adhesive type. Marginal adaptation (MA) was similar to each group, but EB presented noticeable marginal deterioration. Wear was noticed in the 3-step etch-and-rinse (MP) restorations evaluated after 42 months. For the EB, baseline and 18-month wear evaluation were statistically similar. After 36 and 42 months, wear was also similar for EB. Conclusions: Adhesive systems showed similar performance within most important adhesive bonding efficiency achievement parameters: RET, MA, interfacial staining, recurrent caries, and postoperative sensitivity evaluated during 42 months.

Keywords: Clinical trial, dentin adhesive, marginal adaptation, wear

How to cite this article:
Dutra-Correa M, Kiyan VH, Ciaramicoli MT, Pecorari V, Rodrigues FP, Coury Saraceni CH. Randomized clinical trial of four adhesion strategies: A 42 month study. Indian J Dent Res 2019;30:487-95

How to cite this URL:
Dutra-Correa M, Kiyan VH, Ciaramicoli MT, Pecorari V, Rodrigues FP, Coury Saraceni CH. Randomized clinical trial of four adhesion strategies: A 42 month study. Indian J Dent Res [serial online] 2019 [cited 2019 Dec 9];30:487-95. Available from: http://www.ijdr.in/text.asp?2019/30/4/487/271062

   Introduction Top


Resin-composites are adhered to dental tissues using etching, priming and bonding strategies, aiming to improve the longevity of the restorations. The adhesives clinical effectiveness has been extensively reported [1],[2],[3],[4],[5],[6],[7],[8],[9],[10],[11],[12],[13],[14] for noncarious cervical lesions (NCCLs). However, there is a lack of evaluation of secondary caries, wear, and surface texture (ST) (all modified U. S. Public Health Service-USPHS parameters), which can affect their strategies and their effect on NCCL restoration longevity.[15]

In spite of different classifications of adhesive systems, it is well-known that current strategies depend on how the adhesive interacts with the smear layer. Etch-and-rinse adhesives remove the smear layer on acid-etching, while self-etch adhesives make the smear layer permeable without removing it completely. Self-etch adhesives consist of nonrinsing acidic monomers dissolved in an aqueous solution. Because the preparation is not rinsed, these materials are more user-friendly as the application time is reduced, compared to etch-and-rinse adhesives.

This study was designed to evaluate, after 42 months, the bonding efficacy of four dentin adhesive systems strategies on the NCCLs.


   Subjects and Methods Top


Trial design and clinical procedures

A total of 125 NCCLs in 39 patients were randomly assigned to a restorative treatment. The inclusion criteria were: (i) the need of NCCLs; (ii) 18–80 years of age with vital teeth to be restored, with normal natural dentition occlusion, at least one adjacent tooth contact, and healthy periodontal tissues. The exclusion criteria were: The presence of caries or fractured teeth; hypersensitivity; worn parafunction facets in posterior teeth and noncommitment for recalls; long-term drug-therapies/chronic diseases; pregnancy; allergies (drugs; food, etc.); ongoing orthodontic treatment; any indirect restorations; periodontal diseases; any cavity with no need for restoration (no sensitivity; superficial enamel loss); and involvement with another trial (tooth).

All patients received explanations about the clinical trial and were asked to sign an informed consent form, previously reviewed and approved by the Institutional Review Board (336/09). All 39 patients were aged between 22 and 78 (average of 47.6), and had been referred to the Operative Dentistry Clinic and received a dental examination from a member of the clinical dental research group. All materials [Table 1] were used according to manufacturer's instructions.
Table 1: Materials, batch numbers, and compositions

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Each patient had up to four restorations placed, and each dentin adhesive type was applied to one tooth, nonbeveled cavosurface angles, and nonplaced retentive grooves. Each patient could receive in maximum four restorations and at least two restorations. All 125 NCCLs were randomized distributed into four groups of adhesives from the same manufacturer (3M ESPE, St Paul, MN, USA): (1) a three-step etch-and-rinse adhesive, adper scotchbond multi-purpose (MP) (n = 29); (2) a two-step etch-and-rinse adhesive, adper single bond plus – (SB) (n = 32); (3) a two-step self-etch adhesive, Adper Scotchbond SE– SE (n = 30); and (4) a one-step self-etch adhesive, adper easy bond – EB (n = 34). A nanofilled resin-composite (Filtek Supreme Plus, 3M ESPE, St. Paul, MN, USA) was used for all restorations and was inserted in increments of 1.0–1.5 mm, polymerized for 40 s with a light-curing unit (Elipar Freelight 2, 3M ESPE, St. Paul, MN, USA) with an irradiance of 1,000 mW/cm 2, controlled by a radiometer (Spring LightMeter, USA). Finishing and polishing procedures were performed by aluminum oxide disks of decreasing abrasiveness (Sof-Lex XT, 3M ESPE, St. Paul, MN, USA). Restorations were evaluated after 18, 36, and 42 months using modified U.S. Public Health Service (USPHS) parameters.

A total of four operators had advanced training in operative dentistry and were individually instructed by the study coordinator. Calibration exercises were done before performing the clinical trial restoration placement. In addition, the operators were properly calibrated in accordance to the Clinical Evaluation of Restorations– CER (http://www.snapdragonmedia.com/projects/UMDental/CER/training/02-CER-Training/Training-Module1-Posterior-Composites/0-Training-Choices.htm) for teaching and online research purposes. Each operator inserted an average of 30 restorations.

Clinical evaluation

The lesion size (using a millimetric probe) and the sclerosis degree (1 or 2, according to the University of North Carolina (UNC) sclerosis scale,[16] were evaluated before restorative procedures. Restorations were evaluated immediately after their placement (baseline), at 18, 36, and 42 months, using the UNC-modified USPHS criteria in which the restorations were classified under three different scores: Alpha (A = excellent); Bravo (B = clinically acceptable); and Charlie (C = clinically unacceptable) for eleven different parameters: retention (RET); color match (CM); interfacial staining (IS); recurrent caries (RC); wear (W); marginal adaptation (MA); surface texture (ST); postoperative sensitivity-query (PQ); postoperative sensitivity-air (PA); fracture (FRA); and other described failures (OF). The postoperative sensitivity was assessed 1 week after the clinical procedure with a telephone interview. Each restoration was evaluated by two clinicians at each recall, and they were not allowed to evaluate their own work. A third clinician was assigned for possible nonconsensus cases. Intraoral color photographs (×1.5) obtained using a Nikon D40X camera with a 200-mm Medical Nikkor lens (Nikon Inc, Melville, NY, USA), were taken at baseline and recall appointments.

The cumulative failure percentage apart from the RET rate was calculated (only based on alpha parameters). RET rate is based on the alpha parameter and only considers the patient coming in each specific recall, while the cumulative failure considers the restoration survival along the given period. This parameter was calculated using the following equation, according to the American Dental Association Council on Scientific Affairs Program Guidelines:[17]



where PF is the number of previous failures before the current recall, NF is the number of new failures during the current recall and RR is the number of currently recalled restorations.

Statistical analysis

The considered factors for the statistical analysis of this study were: (1) Adhesive systems– four levels (Adper scotchbond MP; adper SB plus; adper scotchbond SE; adper EB) and (2) Period– four levels (6; 18; 36; and 42 months). The restoration was considered an experimental unit, with a total of 19 for the MP adhesive, followed by 18 for SB, 14 for SE Bond, and 18 for EB. Only the restorations of patients who completed 42 months of evaluation were considered for the present study calculations. Patients who discontinued or declined their participation as a subject on this clinical research were excluded from this stage of analysis. A nonparametric analysis was performed with obtained data. For the comparison among the adhesive systems in each period, the Kruskal-Wallis test (KW in Result tables) was performed, and for a comparison along the periods, the Friedman analysis was applied. Numerical scores (0 [Alpha], 1 [Beta], and 2 [Charlie] represented the letters of UNC modified USPHS for allowing the comparisons. The analysis was based in the restorations that did not change from baseline.

A Kaplan–Meier survival analysis was also performed for survival probability calculation in a given period, where the period is a set of small-time ranges. For each period, survival probability was calculated. The survival probability at any particular period was calculated using the formula given below:



Total survival probability up to that period is calculated by multiplying all the probabilities of survival at all ranges which precede the period.


   Results Top


Participants flow is represented in [Figure 1],[18] which shows the number of participants who were randomly assigned, received treatment and were analyzed for each group. Drop-outs and exclusions after randomization, including reasons, were also reported in [Figure 1]. The baseline demography and characteristics for each group are shown in [Table 2].
Figure 1: CONSORT flow diagram

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Table 2: Patients and noncarious cervical lesions characterization

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At 18, 36, and 42 months, 94, 68, and 72 restorations were evaluated, respectively, presenting a recall rate of 75.2%, 54.4%, and 57.6% [Table 3]. At 42-month RET rates (%) were 100 for MP; 94.7 for SB; 87.5 for SE; and 100 for EB at each recall [Table 3]. The cumulative failure percentage (for 42 months) was 9.52% for MP, 9.52% SB, 15.8% SE, and 10% for EB. From the Kaplan Meier analysis [Figure 2], there was no statistical difference in the restorations survival as a function of the type of adhesive. Two restorations were lost in 42 months for MP, SB, and EB. For the SE group, three restorations were lost along the same period.
Table 3: Summary of direct evaluations: Percentage of restorations with Alfa scores for each criterion at each recall

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Figure 2: Kaplan–Meier curve

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The results for the different adhesive systems were not statistically different along the periods (P > 0.05) within any of the parameters, except for MA and wear. The same was observed for the adhesive systems in the same period (P > 0.05).

No statistical differences among test groups were found in regards to MA over time (P > 0.05). EB showed deterioration in regards to MA over time (P < 0.05), [Table 4]. For wear parameter evaluation of the NCCL restorations, the adhesive systems were not statistically different within each period (P > 0.05) but they were statistically different along the periods for the MP and EB groups (P < 0.05). For MP, the baseline was statistically different when compared to the restoration evaluated after 42 months. For EB, baseline and 18-month wear evaluation were statistically similar. At 36- and 42-month, wear was also similar for EB.
Table 4: Means of scores of the wear and marginal adaptation parameters ranking for different adhesive systems along the 42 months

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The results for the pre- and post-operative sensitivity up to 18-month were previously reported by Perdigão et al., (2012).[19] There was no statistical difference for dentin sensitivity after 18, 36, and 42-month for all adhesives using Friedman analysis (P > 0.05).

Restorations using all adhesives in the same patient (Patient #25) can be visualized in [Figure 3].
Figure 3: Restorations using all adhesives in the same patient

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   Discussion Top


Using a variety of parameters [Table 4] and following the CONSORT flow [18] [Figure 1], the 42-month clinical trial allowed the assessment of the four-dentin adhesive systems performance in NCCLs. Practitioner variability did not affect the results of this study as verified by the clinical trial coordinator at the end of data registration.

This study RET rate after 42-month (88.79%) was satisfactorily comparable to some previous short-term controlled clinical trials (86.33% after 36 months;[20] 95% after 24 months;[21] 77.3% after 18 months;[22] 89.5% after 12 months.[4] A correlation between the adhesive strategies or the materials composition and the RET rate could be expected. However, some authors who studied etch and rinse adhesives [20] have already reported that the solvent type may not be a major factor in NCCLs restorations RET as both single-bottle and conventional two-bottle etch and rinse adhesives usually perform acceptably. Three adhesives (MP, SB, and EB) of the current study presented a 42-month RET rate, which is in accordance to the American Diabetes Association guidelines for 6 months (at least, 95% for provisional acceptance). SE presented a RET rate in accordance to the ADA guidelines only for 18 months (at least 90%)[17] yet satisfactory. A study [23] evaluated the clinical performance of dentinal adhesives in seven various material/technique combinations, and no statistically significant differences were observed after 2 years in terms of RET, sensitivity or USPHS categories.

Although the IS did not change statistically within 6 months from baseline for any of the adhesives, it was already reported in the previous study that it was statistically worse at 18-month than at baseline for the two self-etch adhesives EB and SE (both at P = 0.031).[19] However, both self-etch and etch-and-rinse adhesives showed RET rates in NCCLs that were not statistically different after 36 months. Self-etch adhesive showed faster and more progressive enamel marginal degradation, in the current (for EB) and a previous study.[8] Some authors indicated the application of multiple adhesive coats with an improved clinical performance of the acetone-based adhesive,[24] and reported that when an extra layer of a hydrophobic bonding resin was added (MP adhesive), the RET rate increased to 93.4%.

An author [25] alerted that wear may be of minimal importance for restorations of small to moderate size. However, failure rates are higher for larger restorations, and it was included in the present study as an additional factor for evaluation since it is recognized as a multifactorial phenomenon. In the EB group, from the patients' protocol notes, the loss (RET) occurred for the restorations with greater width. Cavities restored with SB and SE seemed to present better or more stable behavior along 42-month.

MA was reported with no statistical difference along 3-year clinical evaluations.[16],[20] The same was observed for the CM; nevertheless, it is usually notable during clinical inspections.[20] Some other authors reported that restorations in all groups investigated showed progressive marginal deterioration within the limits of clinical acceptance.[26] In the current study, MA was statistically similar in the same group (P > 0.05), but EB presented a noticeable premature MA loss (P < 0.05). In a study with 39 patients and 150 restorations investigating the 2-year clinical effectiveness of three adhesives in NCCLs,[6] the Scotchbond MP (SBMP Group) was found to have significantly greater MA, which corroborates to the present study results [Tables 2]. After placing a total of 99 NCCLs restorations using either a filled ethanol-based adhesive or an unfilled acetone-based adhesive, in 33 patients with a total of 56 examined restorations, authors from an 8-year clinical evaluation revealed poor MA in only 15% and RC was 40% for the restorations applied with filled ethanol-based adhesive. Despite the high incidence of marginal discoloration, the one-bottle adhesive EB evaluated in the present study provided good clinical RET of NCCLs restorations but might be progressed without a proper cavosurface mechanical RET.[27] In another 3-year clinical evaluation study, MA and color remained excellent, and both adhesives (filled ethanol-based and unfilled acetone-based) performed perfectly in terms of durability with no statistical differences.[16] A previous 5-year randomized controlled prospective study of adhesives in NCCLs,[28] with a total of 159 evaluated restorations (n = 159) placed in 67 patients (n = 67), revealed that the durability of these restorations made with HEMA-free adhesives was successful, showing that the 1-step adhesive is one of the best clinical dentin bonding agents. Another previous study has also found no statistical differences among the studied adhesives, even though hybrid bond restorations showed significant deterioration in MA and cavosurface marginal discoloration after 2 years.

ST of NCCLs restorations is extremely dependent on the initial finishing and polishing procedures [29] as well as the natural characteristics of the material matrix is not to degrade under oral environment.[30],[31],[32],[33],[34] In the present study, although no sealant was applied, the clinical procedure quality/standardization was attested by this ST parameter, as well as the patient commitment and the material quality, for there was no significant differences along or within the evaluated period.

For all adhesives, postoperative sensitivity improved significantly from the preoperative conditions to 1 week after insertion and remained stable for 18 months,[19] but seemed to increase (with no statistical significance) within 36 and 42-month range, probably due to the poor MAs in each group. Regarding sensitivity, after 42 months, a slightly lower incidence of PA when compared to PQ was noted for MP, probably due to enamel etching as an independent step. In addition, another study using different techniques revealed postoperative sensitivity of 5% at baseline and reduction to 2% within a year, with and without additional enamel etching for self-etch adhesives.[35]

The distinction between early failures causes (e.g., MA) and restoration failure causes (e.g., wear) after several years of life-service are the keys for restorations longevity. MA can be further analyzed by finite element analysis for better comprehension of the resin-composite strain in restored teeth as high tensile at the cavosurface was already reported.[36]


   Conclusion Top


Differences among adhesive systems in this 42-month evaluation study can be both related to early failures and restoration loss (RET). The adhesive systems showed similar performance for the parameters, showing that both adhesive strategies used in this study can be used with efficacy for at least 42 months for NCCLs restoration procedures.

Acknowledgment

Special thanks to 3M ESPE for donating all the materials used in this study.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

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Heymann HO, Sturdevant JR, Brunson WD, Wilder AD, Sluder TB, Bayne SC, et al. Twelve-month clinical study of dentinal adhesives in Class V cervical lesions. J Am Dent Assoc 1988;116:179-83.  Back to cited text no. 14
    
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Correspondence Address:
Dr. Maristela Dutra-Correa
Rua Dr. Bacelar, 1212, 4°Andar, São Paulo
Brazil
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdr.IJDR_466_16

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    Figures

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