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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03932929
Other study ID # KA-17088
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2, 2015
Est. completion date September 2, 2018

Study information

Verified date May 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 2, 2018
Est. primary completion date September 2, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 81 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Scotchbond Universal Adhesive (3M ESPE)
Adhesive system

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Hanabusa M, Mine A, Kuboki T, Momoi Y, Van Ende A, Van Meerbeek B, De Munck J. Bonding effectiveness of a new 'multi-mode' adhesive to enamel and dentine. J Dent. 2012 Jun;40(6):475-84. doi: 10.1016/j.jdent.2012.02.012. Epub 2012 Feb 28. — View Citation

Lawson NC, Robles A, Fu CC, Lin CP, Sawlani K, Burgess JO. Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions. J Dent. 2015 Oct;43(10):1229-34. doi: 10.1016/j.jdent.2015.07.009. Epub 2015 Jul 29. — View Citation

Perdigão J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Marginal adaptation 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 From baseline to 36 month
Primary Marginal staining 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 From baseline to 36 month
Primary Retention 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 From baseline to 36 month
Primary Postoperative sensitivity 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 From baseline to 36 month
Primary Seconder caries 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 From baseline to 36 month
See also
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