Clinical trial NCT03932929: 36-Month Clinical Evaluation of a Universal Adhesive
Official title: 36-Month Clinical Evaluation of Different Adhesive Strategies of a Universal Adhesive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Carious Cervical Lesions
Keywords: Non-Carious Cervical Lesions
Universal adhesive
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Marginal adaptation
timeFrame: From baseline to 36 month
measure: Marginal staining
timeFrame: From baseline to 36 month
measure: Retention
timeFrame: From baseline to 36 month
measure: Postoperative sensitivity
timeFrame: From baseline to 36 month
measure: Seconder caries
timeFrame: From baseline to 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
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.
citation: 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.
citation: Perdigao 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.