Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06227715 |
| Other study ID # |
80558721/G-109 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 28, 2016 |
| Est. completion date |
November 28, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Eskisehir Osmangazi University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
