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

NCT ID: NCT05573243

Last Updated: 2025-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2028-01-31

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

Detailed Description

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Conditions

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Non-carious Cervical Lesion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Etch-and-rinse

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

Group Type EXPERIMENTAL

bonding strategies

Intervention Type OTHER

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

Selective enamel etching

G2 Bond Universal bonded to NCCL using selective enamel etching technique

Group Type EXPERIMENTAL

bonding strategies

Intervention Type OTHER

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

self-etch

G2 Bond Universal bonded to NCCL using self-etch technique

Group Type EXPERIMENTAL

bonding strategies

Intervention Type OTHER

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

Interventions

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bonding 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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Pipop Saikaew

Asst. Prof. Pipop Saikaew

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pipop Saikaew, PhD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Faculty of Dentistry, Manidol University

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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de Paris Matos T, Perdigao J, de Paula E, Coppla F, Hass V, Scheffer RF, Reis A, Loguercio AD. Five-year clinical evaluation of a universal adhesive: A randomized double-blind trial. Dent Mater. 2020 Nov;36(11):1474-1485. doi: 10.1016/j.dental.2020.08.007. Epub 2020 Sep 12.

Reference Type RESULT
PMID: 32933775 (View on PubMed)

Other Identifiers

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2022/DT086

Identifier Type: -

Identifier Source: org_study_id

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