Cervical Lesion, Dental
Conditions
Keywords
G2 Bond Universal, Scotchbond Universal Plus, Tokuyama Universal Bond II, Non-Carious Cervical Lesions
Brief summary
The aim of this randomized controlled clinical trial is to evaluate the 12-month clinical performance of restorations placed in NCCLs using universal adhesives with different compositions according to FDI criteria.
Detailed description
This controlled, randomized, single-blind clinical trial will compare the clinical effectiveness of three universal adhesive systems with different compositions in the restoration of non-carious cervical lesions. A total of 30 healthy volunteers aged 18-55 years will be included. Each participant must present with at least three vital posterior teeth with non-carious cervical lesions (≥3 lesions), with both enamel and dentin involvement and with antagonist teeth in occlusion. Each participant will receive restorations using all three adhesive systems in different teeth (split- mouth design). Randomization will be performed using a computer-generated randomization table (Research Randomizer Program). An experienced operator from the Department of Restorative Dentistry will perform all restorative procedures (AUT). Radiographs will be taken at baseline (before treatment) and at 12-, 24- and 36-month follow-up appointments to assess adaptation, marginal integrity, and proximity to the pulp. Additional radiographs will only be taken if clinically indicated (e.g., suspected endodontic involvement). Restorations will be evaluated immediately after placement, at 12-, 24- and 36-month using FDI evaluation criteria.
Interventions
DEVICEG2 Bond Universal, GC Europe N.V., Leuven, Belgium
G2 Bond Universal, GC Europe N.V., Leuven, Belgium
DEVICEScotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
Scotchbond Universal Plus, 3M ESPE, St. Paul, MN, USA
DEVICETokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
Tokuyama Universal Bond II, Tokuyama Dental, Tokyo, Japan
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals aged 18-55 years * No systemic condition contraindicating restorative treatment * Brushing teeth at least twice daily * At least 20 teeth in occlusion * At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth * Completed initial periodontal therapy * Signed informed consent
Exclusion criteria
* Healthy individuals aged 18-55 years * No systemic condition contraindicating restorative treatment * Brushing teeth at least twice daily * At least 20 teeth in occlusion * At least three vital posterior teeth with non-carious cervical lesions and antagonist teeth * Completed initial periodontal therapy * Signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration survival rate at 12 months | From baseline to 12 month | Restoration survival rate at 12 months, defined as: At least 90% of restorations remaining in situ No statistically significant difference among groups according to FDI criteria |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORCansu Atalay, Assoc. Prof.
Hacettepe University
PRINCIPAL_INVESTIGATORAybüke Uslu Tekce, Assist. Prof.
Hacettepe University
PRINCIPAL_INVESTIGATORAyşe Rüya Yazıcı, Prof.
Hacettepe University
Outcome results
None listed