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

March 15, 2023 updated by: Pipop Saikaew, Mahidol University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Faculty of Dentistry, Manidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Etch-and-rinse
G2 Bond Universal bonded to NCCL using etch-and-rinse technique
Other: 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
Experimental: Selective enamel etching
G2 Bond Universal bonded to NCCL using selective enamel etching technique
Other: 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
Experimental: self-etch
G2 Bond Universal bonded to NCCL using self-etch technique
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

October 7, 2022

First Submitted That Met QC Criteria

October 7, 2022

First Posted (Actual)

October 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/DT086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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