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Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month

Primary Purpose

Fissure, Dental, Adhesion

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fissure sealant application
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fissure, Dental focused on measuring fissure sealant, adhesive

Eligibility Criteria

19 Years - 22 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested.

Exclusion Criteria:

  • bad oral health, maloclusion, allergy to resins used

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Universal Adhesive

    Etch-And-Rinse Adhesive

    Arm Description

    universal adhesive

    Etch-And-Rinse Adhesive

    Outcomes

    Primary Outcome Measures

    The evaluation of retention rate of fissure sealants

    Secondary Outcome Measures

    Full Information

    First Posted
    April 5, 2021
    Last Updated
    April 7, 2021
    Sponsor
    Ondokuz Mayıs University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04837469
    Brief Title
    Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
    Official Title
    Randomized Clinical Trial of Fissure Sealants Comparing Universal Adhesive With Etch-And-Rinse Adhesive After 24 Month
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    February 1, 2015 (Actual)
    Study Completion Date
    March 1, 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: This randomized, controlled clinical study aimed to evaluate the performance of one universal adhesive applied with etch-and-rinse or self-etch strategy and one etch-and-rinse adhesive on fissure sealant retention over 24 months. Methodology: 144 sealants were placed on the permanent premolars and molars of 13 subjects. Teeth were divided into three groups SB2(control): Adper Single Bond 2, SBU-ER: Single Bond Universal/etch-and-rinse, SBU-SE: Single Bond Universal/self-etch. After the adhesive application, Fissurit FX was applied and light-cured. Clinical evaluations were done at baseline and at 1 week, 6-, 12-, 18- and 24-month recalls. Visual examination was performed on every visit for evaluation of the sealants. Evaluating criteria were: 1= completely retained; 2= partial loss; 3= total loss. The Pearson Chi-square test was used for each evaluation period.
    Detailed Description
    Thirteen patients with a mean age of 20.5 (range 19-22) were selected among the patients seeking routine dental care from Conservative Dentistry Department who met the inclusion criteria. Inclusion criteria were: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested. Bitewing radiographs were taken. Pellicle and any remaining plaque on the fissures were removed by using slurry of pumice with a slow-speed handpiece. All restorative procedures were performed by the same operator. The teeth were assigned for different group by using a table of random numbers. Group 1 (SB2): Etched with 35% phosphoric acid gel for 30 s, rinsed and dried. Adper Single Bond 2 (3M ESPE St. Paul MN. USA) applied and light cured for 10s with a LED device (Demi Plus; Kerr, Switzerland) Group 2 (SBU-ER) : Etched with 35% phosphoric acid gel for 30s, rinsed and dried. Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied, gently air thinned for 5 s and light cured for 10s with a LED device Group 3 (SBU-SE): Single Bond Universal Adhesive (3M ESPE St. Paul MN.USA) applied for 20 s with vigorous agitation, gently air thinned for 5 s and light cured for 10 s with a LED device A nanofilled fissure sealant, Fissurit FX (Voco,Cuxhaven,Germany) was applied to the fissures and air entrapment was prevented by carefull spreading with a dental probe. The sealant material was light-cured for 20 seconds with LED. The occlusion was checked with articulating paper. Fine-grit diamond burs (Diatech, Swiss Dental, Switzerland) and rubber cups (Edenta AG, AU SG, Switzerland). were used for finishing and polishing. Each restoration was evaluated at baseline,1week after treatment and 6, 12, 18 and 24 months. Evaluation of restorations was carried out by two calibrated examiners who were unaware of group allocation and who were not involved with the treatment procedures, by the help of a mirror, blunt explorer and air stream. Caries formation was evaluated as present or absent and the sealants were evaluated according to the following criteria: 1= Completely retained 2= Partial loss 3= Total loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fissure, Dental, Adhesion
    Keywords
    fissure sealant, adhesive

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Universal Adhesive
    Arm Type
    Experimental
    Arm Description
    universal adhesive
    Arm Title
    Etch-And-Rinse Adhesive
    Arm Type
    Experimental
    Arm Description
    Etch-And-Rinse Adhesive
    Intervention Type
    Procedure
    Intervention Name(s)
    fissure sealant application
    Intervention Description
    fissure sealants were placed after differnt adhesive strategies used
    Primary Outcome Measure Information:
    Title
    The evaluation of retention rate of fissure sealants
    Time Frame
    24 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: good oral hygiene and and the absence of caries, previously placed restorations, bruxism and an allergy to the materials tested. Exclusion Criteria: bad oral health, maloclusion, allergy to resins used

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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