Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive
Condition: Tooth Wear
MeSH terms: Tooth Wear
Study type: Interventional

Summary: 
      Objectives: To evaluate the 36-month clinical performance of Single Bond Universal Adhesive
      (SBU; 3M ESPE, Germany) in non-carious cervical lesions (NCCLs) using different modes
      adhesion approaches according to the FDI criteria.

      Material and methods: SBU Adhesive was applied in 252 NCCLs of 25 patients using different
      modes adhesion approaches: Self-etch (SE), selective-enamel-etching (SLE), total-etch (TE).
      All lesions were restored with nanohybrid resin composite. Restorations were evaluated at
      baseline, 6th, 12th, 18th, and 36th month using the FDI criteria. IBM SPSS Statistics for
      Windows, Version 24.0. program was used in the analysis. Differences between SE, SLE and TE
      groups were tested using Kruskal Wallis test. A value of p<0.05 was accepted as a criterion
      for statistical significance.
    

Detailed description: 
      Study Design Non-Interventional Clinical Research Ethics Committee (80558721/G-109) approved
      the study. All participants were informed of the study and consent forms were obtained. The
      experimental design adhered to the Consolidated Standards of Reporting Trials (CONSORT)
      statements. For this retrospective study, between May 2015 and July 2015, 102 patients who
      were diagnosed with non-carious cervical lesion and had their restoration completed in
      Faculty of Dentistry by single operative dentist. 25 volunteers (10-females, 15-males) with
      the ages ranging from 35 to 72, 252 restorations were selected for this study according to
      predetermined criteria (table 1).

      Sample Size Calculation G* Power statistical software was used to calculate the sample size.
      For an effect size (Cohen 'D Effect Size) difference of 0.30 between the groups with 99%
      power, DF=2 and an alpha error of 5%, at least 238 restorations were needed.

      Patient Selection Adults who achieved the inclusion/exclusion criteria and required
      restoration of at least one notch shaped NCCL were included in the study. Inclusion criteria
      were the presence of at least 20 teeth and 6 NCCL, the absence of common caries, and the use
      of universal adhesive and nanohybrid resin composite. Candidates with poor oral hygiene,
      acute or chronic periodontal disease, xerostomia, and malocclusion were excluded.

      The patient forms, in which the identity information of the patients participating in the
      study and the size of the lesion in the restored teeth, the type and mode of adhesive used in
      the restoration, and the restorative material were recorded, were reviewed and the necessary
      tooth groupings were made following the recorded data.

      Application Procedure of Restorations The NCCL dimensions in millimeters (height and width)
      were determined with a digital caliper. Prior to the restoration procedures, a pumice stone
      and water were used for prophylactic purposes, then the dentin was abraded and beveled to the
      enamel surface (1-2 mm). Before the restoration of the lesions, isolation was achieved with
      the use of retraction cord (Ultrapak, Ultradent Products, USA) and cotton rolls. Three
      different application modes of the universal dentin bonding (Single Bond Universal, 3M ESPE,
      Germany) adhesive were applied in the restoration of the teeth (table 2). These are TE, in
      which both dentin and enamel are etched, SLE, in which only enamel is etched, and SE, in
      which only the adhesive is applied. Each mode of the universal adhesive used in the mouth of
      each of the patients evaluated was applied to at least two teeth. In accordance with the
      recommendations of the manufacturer; in TE mode, enamel and dentin were etched with 37%
      orthophosphoric acid for 15 seconds, washed for 15 seconds, and after air-drying, the
      adhesive was applied to enamel and dentin by rubbing for 20 seconds. In SLE mode, only enamel
      margin was etched for 15 seconds, washed for 15 seconds and dried, and the adhesive was
      applied to the dentin and enamel by rubbing for 20 seconds. In SE mode, the adhesive was
      applied to the dentin and enamel by rubbing for 20 seconds. After the adhesive was applied in
      all modes, it was dried for 5 seconds gently and polymerized 10 seconds using a curing light
      (SmartLite Focus, Dentsply Sirona, USA). Afterwards, all of them were restored with the same
      nanohybrid resin composite (Filtek Z550, 3M ESPE, USA) in accordance with the layering
      technique. Restorations were completed by polishing under water cooling with fine diamond
      burs (GZ Instrumente, Austria) and polishing discs (Soflex Finishing and Polishing Disc, 3M
      ESPE, USA).

      Assessment of Restorations At the 1st, 6th, 12th, 18th, and 36th month, the restorations were
      evaluated based on the FDI criteria and the results were recorded on the clinical research
      follow-up form. Two calibrated experienced dentists evaluated the restorations without
      knowing which adhesive technique was used on which patient, except for the treating dentist,
      using a mirror and sond under reflector light.

      Restorations were evaluated marginal staining, fracture of material and retention, marginal
      adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion and
      abfraction, tooth integrity according to the FDI criteria. According to the FDI criteria,
      these variables were ranked as follows: clinically very good (1), clinically good (2),
      clinically satisfactory (3), clinically unsatisfactory (4), and clinically poor (5). In
      accordance with these criteria, values of 1,2 and 3 are clinically acceptable, while 4 and 5
      are considered clinically not acceptable.16 The difference between the adhesive modes and the
      time-dependent variation within each mode were evaluated. Among the evaluated restorations,
      those with retention loss were evaluated only according to the retention loss criteria and
      scored with 5 and were not evaluated in terms of other criteria. Restorations that were
      unsuccessful due to either loss of retention or irreparable secondary caries were replaced
      with new composite resin restorations. These new restorations were then excluded from the
      study for further evaluation.

      Statistical Analysis Descriptive statistics were used to present the frequency distributions.
      Shapiro Wilk's test was performed to evaluate the normality of data distribution and it was
      seen that data were not normally distributed. Differences between SE, SLE and TE groups were
      tested using Kruskal Wallis test. The was used to compare the groups at baseline, 6, 12, 18
      and 36 months. To compare the data in marginal staining, fracture of material and retention,
      marginal adaptation, post-operative sensitivity and vitality, recurrence of caries, erosion
      and abfraction, tooth integrity within each group by time, further analyses were carried out
      using the K Releated Samples and Wilcoxon tests. IBM SPSS Statistics for Windows, Version
      24.0. (Armonk, NY: IBM Corp., USA) program was used in the analysis. A value of p<0.05 was
      accepted as a criterion for statistical significance.
    

Intervention name(s): universal adhesive
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: nccl; universal bond; acid etching; selective etching