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

Not Applicable

Active, not recruiting

• Conditions: Non-carious Cervical Lesion
• Interventions: Other: bonding strategies

• Registration Number: NCT05573243
• Lead Sponsor: Mahidol University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Study Start: 2023-11-10
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-11
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Etch-and-rinse	bonding strategies	G2 Bond Universal bonded to NCCL using etch-and-rinse technique
Selective enamel etching	bonding strategies	G2 Bond Universal bonded to NCCL using selective enamel etching technique
self-etch	bonding strategies	G2 Bond Universal bonded to NCCL using self-etch technique

Primary Outcome Measures

Name	Time	Method
sensitivity (modified USPHS)	3 years	tooth sensitivity to hot/cold water, tactile
secondary caries (modified USPHS)	3 years	caries recurrent rate after restoration
retention (modified USPHS)	3 years	retention rate of the restoration that retain in the mouth after treatment

Secondary Outcome Measures

Name	Time	Method
marginal adaptation (modified USPHS)	3 years	the quality of the restoration margin

Trial Locations

Locations (1)

Faculty of Dentistry, Manidol University; 🇹🇭 Bangkok, Thailand