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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

36-Month Clinical Evaluation of a Universal Adhesive

Clinicaltrials.gov identifier NCT03932929

Recruitment Status Completed

First Posted May 1, 2019

Last update posted May 6, 2019

Study Description

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.

  • Condition or Disease:Non-Carious Cervical Lesions
  • Intervention/Treatment: Device: Scotchbond Universal Adhesive (3M ESPE)
  • Phase: N/A
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
  • Actual Enrollment: 35 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Other
  • Official Title: 36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive
  • Actual Study Start Date: September 2015
  • Actual Primary Completion Date: September 2018
  • Actual Study Completion Date: September 2018
Arms and interventions
Arm Intervention/treatment
Experimental: Scotchbond universal adhesive (etch-and-rinse)
Acid etch (enamel&dentin)+adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system
Experimental: Scotchbond universal adhesive (selective-etch)
Acid etch (only enamel)+adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system
Experimental: Scotchbond universal adhesive (self-etch)
Adhesive agent Intervention: Device: Adhesive agent
Device: Scotchbond Universal Adhesive (3M ESPE)
Adhesive system
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 81 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts
Locations

Turkey
Hacettepe University
Ankara

Sponsors and Collaborators

Hacettepe University

More Information