CClinicalTrials.gg
CompletedNCT06227715Updated Jan 29, 2024

Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive

An interventional study of universal adhesive in Tooth Wear, sponsored by Eskisehir Osmangazi University. Completed. Open to participants aged 20 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 7 months after the study started (first participant enrolled Apr 2016, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
20 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Tooth Wear

Browse trials for

Keywords

  • nccl
  • universal bond
  • acid etching
  • selective etching
03

In context

Tooth Wear

57 studies on the registry are indexed under Tooth Wear; 10 are open to participants now.

This study's enrollment of 25 is below the median of 49 across 37 interventional studies indexed under Tooth Wear.

Browse Tooth Wear studies →

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 149 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • At least 20 teeth and 6 NCCL
  • The absence of common caries
  • The use of universal adhesive and nanohybrid resin composite

Exclusion criteria

Exclusion Criteria

  • Candidates with poor oral hygiene
  • Acute or chronic periodontal disease
  • Xerostomia,
  • Malocclusion were excluded.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
25 participants (actual)

Study arms

  • Other
    selective etch

    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.

    Other: universal adhesive

  • Other
    Total etch

    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.

    Other: universal adhesive

  • Other
    self etch

    In SE mode, the adhesive was applied to the dentin and enamel by rubbing for 20 seconds.

    Other: universal adhesive

Interventions

  • Otheruniversal adhesive
06

What researchers measure

Primary outcomes

  1. Non-Carious Cervical Lesions Restorations Using Different Modes of Universal Adhesive

    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. Clinically excellent/very good (1) Clinically good (after polishing very good) (2) Clinically sufficient/satisfactory (minor shortcomings, no unacceptable effects but not adjustable w/o damage to the tooth) (3) Clinically unsatis- factory (but reparable) (4) Clinically poor (replacement necessary) (5)

    Time frame: 6, 12, 18, 36, 60 month

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06227715
Lead sponsor
Eskisehir Osmangazi University
Responsible party
Hatice Tepe (Lecturer, Eskisehir Osmangazi University) — Principal investigator
First posted
Jan 29, 2024
Start date
Apr 28, 2016
Primary completion
Oct 28, 2018
Completion
Nov 28, 2023
Last update
Jan 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion