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

N/AActive Not RecruitingNCT05573243

Mahidol University55 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non-carious Cervical Lesion

Interventions

bonding strategiesOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry, Manidol University

Bangkok, Thailand

Outcomes

Primary Outcomes

sensitivity (modified USPHS)

tooth sensitivity to hot/cold water, tactile

Time frame: 3 years

retention (modified USPHS)

retention rate of the restoration that retain in the mouth after treatment

Time frame: 3 years

secondary caries (modified USPHS)

caries recurrent rate after restoration

Time frame: 3 years

Secondary Outcomes

marginal adaptation (modified USPHS)

the quality of the restoration margin

Time frame: 3 years

Data from ClinicalTrials.gov

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