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

NCT06227715 | Completed

• 1 other identifier: 80558721/G-109
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tooth Wear

Keywords

nccl; universal bond; acid etching; selective etching

Outcome Measures

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)

  6, 12, 18, 36, 60 month

Study Arms (3)

selective etch

OTHER

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

Total etch

OTHER

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

self etch

OTHER

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

Other: universal adhesive

Interventions

universal adhesive OTHER

Total etch; selective etch; self etch

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Related Publications (1)

• Tepe H, Celiksoz O, Yaman BC. Clinical evaluation of single bond universal adhesive in non-carious cervical lesions: a 36-month retrospective study. Clin Oral Investig. 2024 Dec 28;29(1):33. doi: 10.1007/s00784-024-06126-y.

  PMID: 39731636 DERIVED

Related Links

• FDI Criteria for dental restorations

MeSH Terms

Conditions

Tooth Wear

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 29, 2024
• Study Start: April 28, 2016
• Primary Completion: October 28, 2018
• Study Completion: November 28, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01