Clinical Evaluation of Composite Restorations Using Two-steps Universal Adhesive in Non-carious Cervical Lesion (NCCL)

Study Overview
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Brief Summary
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The goal of this clinical study is to compare the clinical performance of a new 2-steps universal adhesive in patients with non-carious cervical lesions. The main question it aims to answer is: Is there any difference in clinical performance of a new 2-steps universal adhesives bonded with different etching strategies. Participants will have restorations using a new 2-steps universal adhesives in different etching strategies. etch-and-rinse selective enamel etching self-etch

Official Title
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Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial

Conditions
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Non-carious Cervical Lesion

Intervention / Treatment
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* Other: bonding strategies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Available for follow-up visits Have at least 28 teeth/ 20 teeth under occlusion Have at least 3 non-carious cervical lesions without peri-apical lesion. The lesion is not nearly exposed pulp and no history of previous restoration. Exclusion Criteria: Rampant / uncontrolled caries Advanced untreated periodontal disease >2 cigarette packs/day Systemic or local disorders that could not undergo dental procedures Xerostomia Severe bruxism, clenching, TMD Pregnancy at the time of screening Known history of sensitivity to resin or related materials Fixed orthodontic appliance or planning to have orthodontic treatment within 3 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Etch-and-rinse<br>G2 Bond Universal bonded to NCCL using etch-and-rinse technique | Other: bonding strategies<br>* The universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch<br>|
| Experimental: Selective enamel etching<br>G2 Bond Universal bonded to NCCL using selective enamel etching technique | Other: bonding strategies<br>* The universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch<br>|
| Experimental: self-etch<br>G2 Bond Universal bonded to NCCL using self-etch technique | Other: bonding strategies<br>* The universal adhesive can be bonded using 3 different bonding strategies. Therefore, three bonding strategies will be assigned for 3 arms: etch-and-rinse, selective enamel etching, self-etch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity (modified USPHS) | tooth sensitivity to hot/cold water, tactile | 3 years | 
| retention (modified USPHS) | retention rate of the restoration that retain in the mouth after treatment | 3 years | 
| secondary caries (modified USPHS) | caries recurrent rate after restoration | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal adaptation (modified USPHS) | the quality of the restoration margin | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical trial, universal adhesive, etch-and-rinse, selective enamel etching, self-etch