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

NCT05573243 | Active Not Recruiting

• 1 other identifier: 2022/DT086
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Conditions

Non-carious Cervical Lesion

Keywords

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

Outcome Measures

Primary Outcomes (3)

• sensitivity (modified USPHS)

  tooth sensitivity to hot/cold water, tactile

  3 years

• retention (modified USPHS)

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

  3 years

• secondary caries (modified USPHS)

  caries recurrent rate after restoration

  3 years

Secondary Outcomes (1)

• marginal adaptation (modified USPHS)

  3 years

Study Arms (3)

Etch-and-rinse

EXPERIMENTAL

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

Other: bonding strategies

Selective enamel etching

EXPERIMENTAL

G2 Bond Universal bonded to NCCL using selective enamel etching technique

Other: bonding strategies

self-etch

EXPERIMENTAL

G2 Bond Universal bonded to NCCL using self-etch technique

Other: bonding strategies

Interventions

bonding strategies 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

Etch-and-rinse; Selective enamel etching; self-etch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Dentistry, Manidol University

Bangkok, 10400, Thailand

Location

Related Publications (1)

• 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.

  PMID: 32933775 RESULT

Study Officials

• Pipop Saikaew, PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Pipop Saikaew

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 10, 2022
• Study Start: November 10, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)