Clinical trial NCT02897089: Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives
Official title: Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries on Pit and Fissure Surface
Keywords: universal adhesive
fissure sealants
retention
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Teeth having clinical indication of sealing with pit and fissure sealant.
* Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures.

Exclusion Criteria:

* Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
* Patients with systemic diseases.

Primary outcomes:
measure: Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hacettepe University
name: Zafer C Cehreli, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.