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Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Clinical Performance of Fissure Sealants Bonded With Total and Self-etch Modes of Universal Adhesive Agents

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02897089
Enrollment
100
Registered
2016-09-13
Start date
2022-03-31
Completion date
2025-03-30
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries on Pit and Fissure Surface

Keywords

universal adhesive, fissure sealants, retention

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.

Interventions

DEVICEAdhesive agent

Agents used to bond the restorative materials to teeth structure.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria24 monthsLong-term clinical success of different universal adhesives under fissure sealants

Contacts

Primary ContactZafer C Cehreli, Prof
zcehreli@gmail.com00903123052280
Backup ContactGizem Erbas Unverdi, Research As.
erbasgizem@yahoo.com00903123052280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026