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NCT Number: NCT05573243

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non-carious Cervical Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Manidol University

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. sensitivity (modified USPHS)

    Time frame: 3 years

    tooth sensitivity to hot/cold water, tactile

  2. retention (modified USPHS)

    Time frame: 3 years

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

  3. secondary caries (modified USPHS)

    Time frame: 3 years

    caries recurrent rate after restoration

Secondary outcomes

  1. marginal adaptation (modified USPHS)

    Time frame: 3 years

    the quality of the restoration margin

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Acronym: NCCL

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Oct 10, 2022
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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