Non-carious Cervical Lesions Clinical Trial
Official title:
Clinical Performance of a One-step Self-etch Adhesive in Non-carious Cervical Lesions at 2 Years
Verified date | September 2020 |
Source | University of Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Objectives: One-step self-etch adhesives are the latest adhesives introduced into the market.
The aim of this randomized controlled clinical trial was to test the hypothesis that a
one-step self-etch adhesive performs equally well as a two-step etch-and-rinse adhesive.
Materials and methods: Thirty two patients with 96 non-carious cervical lesions received
composite-resin restorations (Tetric Evo Ceram - Ivoclar/Vivadent), which were bonded either
with a one-step self-etch adhesive (AdheSE One - Ivoclar/Vivadent) with or without enamel
etching, or with a two-step etch-and-rinse adhesive (ExiTE - Ivoclar/Vivadent). All
restorations were evaluated by two examiners at baseline, 6, 12, 18 and 24 months regarding
retention, caries recurrence, marginal integrity and discoloration. Retention loss, severe
marginal defects and/or discoloration that needed intervention (repair or replacement) and
occurrence of caries, were considered as clinical failures. A logistic regression analysis
with generalized estimating equations was used to account for the clustered data (three
restorations per patient).
Status | Active, not recruiting |
Enrollment | 32 |
Est. completion date | October 10, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: At least three non-carious cervical lesions on incisors, canines and premolars of the upper or lower jaw. Each lesion should be located at the cervical third of the buccal side of the tooth, be either at the same level or above the gums, have its cervical wall on dentin, not extend on adjacent surfaces and not exceed 5mm in length, 3mm in height and 1.5mm in depth Exclusion Criteria: Patients receiving periodontal therapy, presenting high caries activity or TMJ problems needing treatment with mouthguards, were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Greece | University of Athenss | Athens | Attica |
Lead Sponsor | Collaborator |
---|---|
University of Athens |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Retention of the restorations | percentage of retained restorations | 2 years | |
Primary | Recurrent caries during examination | percentage of lesion with recurrent caries | 2 years | |
Primary | Marginal adaptation of the restorations | Measured in µm | 2 years | |
Primary | Marginal discolouration of the restorations | percentage of stained lesions | 2 years |
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