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Clinical Trials/NCT05573243
NCT05573243
Active, not recruiting
Not Applicable

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

Mahidol University1 site in 1 country55 target enrollmentNovember 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-carious Cervical Lesion
Sponsor
Mahidol University
Enrollment
55
Locations
1
Primary Endpoint
sensitivity (modified USPHS)
Status
Active, not recruiting
Last Updated
last year

Overview

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
Registry
clinicaltrials.gov
Start Date
November 10, 2023
End Date
January 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pipop Saikaew

Asst. Prof. Pipop Saikaew

Mahidol University

Eligibility Criteria

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

Outcomes

Primary Outcomes

sensitivity (modified USPHS)

Time Frame: 3 years

tooth sensitivity to hot/cold water, tactile

secondary caries (modified USPHS)

Time Frame: 3 years

caries recurrent rate after restoration

retention (modified USPHS)

Time Frame: 3 years

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

Secondary Outcomes

  • marginal adaptation (modified USPHS)(3 years)

Study Sites (1)

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