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The purpose of this study is to evaluate and compare the clinical retention of a resin-based fissure sealant placed with prior application of etch-and-rinse and self-etch modes of universal adhesives.
Sealants will placed on previously unsealed, caries-free permanent first molars, employing a split-mouth design. 100 patients will be included the study. The teeth will be randomized into eight groups according to the adhesive systems and modes placed under the tested resin-based sealant.
Group1: Acid-Etch + Fissure sealant (ClinPro 3M ESPE, U.S.) (Control arm) Group2: All Bond Universal (Bisco Inc., Schaumburg,IL, U.S.) - with self etch technique + Fissure sealant ; Group3: All Bond Universal - total etch technique + Fissure sealant Group4: Scotchbond (Single Bond) Universal (3M ESPE, U.S.) - self etch technique + Fissure sealant Group5: Scotchbond (Single Bond) Universal - total etch technique + Fissure sealant Group6: Clearfil Universal Bond (Kuraray, Tokyo, Japan) - self etch technique + Fissure sealant Group7: Clearfil Universal Bond- total etch technique + Fissure sealant Group8: Single Bond Plus (3M ESPE)- total etch technique + Fissure sealant
Clinical assessments will be performed according to modified USPHS criteria at 3, 6, 12, 18 and 24 months. Retention, seconder caries, marginal adaptation and marginal discoloration of the sealants will be evaluated.
The data will be analyzed statistically using Fisher's Exact test and Kaplan-Meier analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acid-etch | No Intervention | Acid etch+fissure sealant | |
| All Bond universal adhesive | Other | Acid etch+ All Bond universal adhesive agent+fissure sealant |
|
| All Bond universal | Other | All Bond universal adhesive agent+fissure sealant |
|
| Scotchbond universal adhesive | Other | Acid etch+ Scotchbond universal adhesive agent+fissure sealant |
|
| Scotchbond universal | Other | Scotchbond universal adhesive agent+fissure sealant |
|
| Clearfil universal adhesive | Other | Acid etch+ Clearfil universal adhesive agent+fissure sealant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adhesive agent | Device | Agents used to bond the restorative materials to teeth structure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria | Long-term clinical success of different universal adhesives under fissure sealants | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zafer C Cehreli, Prof | Contact | 00903123052280 | zcehreli@gmail.com | |
| Gizem Erbas Unverdi, Research As. | Contact | 00903123052280 | erbasgizem@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Zafer C Cehreli, Prof | Hacettepe University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25864681 | Background | McCafferty J, O'Connell AC. A randomised clinical trial on the use of intermediate bonding on the retention of fissure sealants in children. Int J Paediatr Dent. 2016 Mar;26(2):110-5. doi: 10.1111/ipd.12165. Epub 2015 Apr 10. | |
| 11145354 | Background | Feigal RJ, Musherure P, Gillespie B, Levy-Polack M, Quelhas I, Hebling J. Improved sealant retention with bonding agents: a clinical study of two-bottle and single-bottle systems. J Dent Res. 2000 Nov;79(11):1850-6. doi: 10.1177/00220345000790110601. |
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| Clearfil universal | Other | Clearfil universal adhesive agent+fissure sealant |
|
| Total-etch Dental Adhesive | Other | Acid etch+ Single Bond adhesive agent+fissure sealant |
|
| 23210859 | Background | Karaman E, Yazici AR, Tuncer D, Firat E, Unluer S, Baseren M. A 48-month clinical evaluation of fissure sealants placed with different adhesive systems. Oper Dent. 2013 Jul-Aug;38(4):369-75. doi: 10.2341/12-181-C. Epub 2012 Dec 4. |