36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hacettepe University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Marginal adaptation
Study Overview
Brief Summary
The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.
Detailed Description
One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 81 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •over 18 years old
- •good oral hygiene
- •available for recall
- •at least 20 teeth under occlusion
- •the presence of at least three non-carious cervical lesions
Exclusion Criteria
- •poor oral hygiene
- •bruxism habits
- •severe or chronic periodontitis
- •If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.
Arms & Interventions
Scotchbond universal adhesive (self-etch)
Adhesive agent Intervention: Device: Adhesive agent
Intervention: Scotchbond Universal Adhesive (3M ESPE) (Device)
Scotchbond universal adhesive (selective-etch)
Acid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent
Intervention: Scotchbond Universal Adhesive (3M ESPE) (Device)
Scotchbond universal adhesive (etch-and-rinse)
Acid etch (enamel&dentin)+adhesive agent Intervention: Device: Adhesive agent
Intervention: Scotchbond Universal Adhesive (3M ESPE) (Device)
Outcomes
Primary Outcomes
Marginal adaptation
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal adaptation. Marginal adaptation was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores; Alfa: Closely adapted, no visible crevice. Bravo: Visible crevice, explorer will penetrate. Charlie: Crevice in which dentin is exposed
Postoperative sensitivity
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: Not present. Bravo: sensitive but diminishing in intensity. Charlie:constant sensitivity, not diminishing in intensity
Marginal staining
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding marginal staining. Marginal staining was evaluated by 2 independent clinicians. Visual inspection with a mirror was performed . Scores: Alfa: No discoloration. Bravo: Discoloration without. Charlie: Discoloration with penetration in pulpal direction
Retention
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No loss of restorative material. Charlie: Any loss of restorative material
Seconder caries
Time Frame: From baseline to 36 month
Observers evaluated the restorations was performed using the modified United State Public Health Service criteria regarding retention rate. Retention rate was evaluated by 2 independent clinicians. Scores: Alfa: No caries present. Charlie: Caries present
Secondary Outcomes
No secondary outcomes reported
Investigators
Cansu Atalay
Pricipal Investigator, DDS, PhD
Hacettepe University