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

Mahidol University

Status: Active, not recruiting

Conditions: Non-carious Cervical Lesion

Treatments: Other: bonding strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT05573243

2022/DT086

Details and patient eligibility

About

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

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 3 patient groups

Etch-and-rinse

Experimental group

Description:

G2 Bond Universal bonded to NCCL using etch-and-rinse technique

Treatment:

Other: bonding strategies

Selective enamel etching

Experimental group

Description:

G2 Bond Universal bonded to NCCL using selective enamel etching technique

Treatment:

Other: bonding strategies

self-etch

Experimental group

Description:

G2 Bond Universal bonded to NCCL using self-etch technique

Treatment:

Other: bonding strategies