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Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

Primary Purpose

Dental Caries on Pit and Fissure Surface

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adhesive agent
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dental Caries on Pit and Fissure Surface focused on measuring universal adhesive, fissure sealants, retention

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    No Intervention

    Other

    Other

    Other

    Other

    Other

    Other

    Other

    Arm Label

    acid-etch

    All Bond universal adhesive

    All Bond universal

    Scotchbond universal adhesive

    Scotchbond universal

    Clearfil universal adhesive

    Clearfil universal

    Total-etch Dental Adhesive

    Arm Description

    Acid etch+fissure sealant

    Acid etch+ All Bond universal adhesive agent+fissure sealant

    All Bond universal adhesive agent+fissure sealant

    Acid etch+ Scotchbond universal adhesive agent+fissure sealant

    Scotchbond universal adhesive agent+fissure sealant

    Acid etch+ Clearfil universal adhesive agent+fissure sealant

    Clearfil universal adhesive agent+fissure sealant

    Acid etch+ Single Bond adhesive agent+fissure sealant

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2016
    Last Updated
    March 12, 2021
    Sponsor
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02897089
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 31, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2024 (Anticipated)
    Study Completion Date
    March 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hacettepe University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries on Pit and Fissure Surface
    Keywords
    universal adhesive, fissure sealants, retention

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    acid-etch
    Arm Type
    No Intervention
    Arm Description
    Acid etch+fissure sealant
    Arm Title
    All Bond universal adhesive
    Arm Type
    Other
    Arm Description
    Acid etch+ All Bond universal adhesive agent+fissure sealant
    Arm Title
    All Bond universal
    Arm Type
    Other
    Arm Description
    All Bond universal adhesive agent+fissure sealant
    Arm Title
    Scotchbond universal adhesive
    Arm Type
    Other
    Arm Description
    Acid etch+ Scotchbond universal adhesive agent+fissure sealant
    Arm Title
    Scotchbond universal
    Arm Type
    Other
    Arm Description
    Scotchbond universal adhesive agent+fissure sealant
    Arm Title
    Clearfil universal adhesive
    Arm Type
    Other
    Arm Description
    Acid etch+ Clearfil universal adhesive agent+fissure sealant
    Arm Title
    Clearfil universal
    Arm Type
    Other
    Arm Description
    Clearfil universal adhesive agent+fissure sealant
    Arm Title
    Total-etch Dental Adhesive
    Arm Type
    Other
    Arm Description
    Acid etch+ Single Bond adhesive agent+fissure sealant
    Intervention Type
    Device
    Intervention Name(s)
    Adhesive agent
    Intervention Description
    Agents used to bond the restorative materials to teeth structure.
    Primary Outcome Measure Information:
    Title
    Completion of clinical evaluations (retention, secondary caries, marginal adaptation and marginal discoloration) of all teeth assessed by modified USPHS criteria
    Description
    Long-term clinical success of different universal adhesives under fissure sealants
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zafer C Cehreli, Prof
    Phone
    00903123052280
    Email
    zcehreli@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gizem Erbas Unverdi, Research As.
    Phone
    00903123052280
    Email
    erbasgizem@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zafer C Cehreli, Prof
    Organizational Affiliation
    Hacettepe University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    25864681
    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.
    Results Reference
    background
    PubMed Identifier
    11145354
    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.
    Results Reference
    background
    PubMed Identifier
    23210859
    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.
    Results Reference
    background

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    Effectiveness of Fissure Sealants Bonded With Different Universal Adhesives

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