Long-term Clinical Evaluation of Composite Restoration Using Two-steps Universal Adhesive in Non-carious Cervical Lesion: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Mahidol University
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- sensitivity (modified USPHS)
Study 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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Etch-and-rinse
G2 Bond Universal bonded to NCCL using etch-and-rinse technique
Intervention: bonding strategies (Other)
Selective enamel etching
G2 Bond Universal bonded to NCCL using selective enamel etching technique
Intervention: bonding strategies (Other)
self-etch
G2 Bond Universal bonded to NCCL using self-etch technique
Intervention: bonding strategies (Other)
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)
Investigators
Pipop Saikaew
Asst. Prof. Pipop Saikaew
Mahidol University