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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05573243

Acronym

NCCL

Enrollment

Registered

2022-10-10

Start date

2023-11-10

Completion date

2028-01-31

Last updated

2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-carious Cervical Lesion

Keywords

clinical trial, universal adhesive, etch-and-rinse, selective enamel etching, self-etch

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

Interventions

OTHERbonding strategies

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
marginal adaptation (modified USPHS)	3 years	the quality of the restoration margin

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026