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Effect of Er:YAG Laser on Hydrophilic Sealants

Sponsor
Aydin Adnan Menderes University (Other)
Overall Status
Completed
CT.gov ID
NCT03718689
Collaborator
(none)
44
Enrollment
1
Location
3
Arms
9.4
Actual Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study was conducted on 44 (19 girls and 25 boys) patients presenting 132 permanent first molars, who applied for oral examination to Adnan Menderes University Faculty of Dentistry Department of Pediatric Dentistry. The patients involved in the study were aged between 7-11 years who had fully erupted permanent first molars, which were suitable for non-invasive fissure sealant application (narrow, deep fissures).

Condition or Disease Intervention/Treatment Phase
  • Device: Laser etching
 N/A

Detailed Description

The permanent first molar teeth were cleaned using a polishing brush and pumice and isolated with cotton rolls. Caries status was assessed using DIAGNOdent pen (DIAGNOdent pen 2190, KaVo, Biberach, Germany) at the occlusal and proximal sites. Teeth having DIAGNOdent readings of 12 or less at the occlusal site and 7 or less at the proximal site were included in the study. Then, the teeth were divided into three groups. The first group (Grup A) of teeth were etched with phosphoric acid, the second group of teeth (Group L) were etched with Er:YAG laser and the third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid. The patients were recalled for follow up examination at the 3rd, 6th and 9th months. The teeth were assessed using mouth mirror and explorer regarding new caries formation and retention of the fissure sealants. The obtained data were analyzed using SPSS 24.0 (SPSS 24.0 for Windows, SPSS Inc., Chicago, IL, USA).

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Er:YAG Laser on Clinical Success of a Hydrophilic Fissure Sealant
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Oct 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group L

The second group of teeth (Group L) were etched with Er:YAG laser.

Device: Laser etching
Acid etching
Other Names:
  • Acid

    		•
    Experimental: Group A+L

    The third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid.

    Device: Laser etching
    Acid etching
    Other Names:
  • Acid

    		•
    No Intervention: Group A

    The first group of teeth (Group A) were not etched with Er:YAG laser.

    Outcome Measures

    Primary Outcome Measures

    1. Retention rate [Change from Baseline retention rate at 12 months]

      Clinical success

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients who participated in this study had good general health and oral hygiene.

    • Fully erupted permanent first molar teeth with deep, narrow fissures

    • Teeth with no detectable occlusal and proximal caries

    Exclusion Criteria:

    • Hypomineralized areas such as fluorosis, molar incisor hypomineralization

    • Allergy to resins, who were not willing to participate in the study.

    • Teeth with hypomineralized areas such as fluorosis,

    • Teeth with molar incisor hypomineralization

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hülya Yılmaz Aydın Turkey 09100

    Sponsors and Collaborators

    • Aydin Adnan Menderes University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sultan KELES, Assist. Prof.Dr., Aydin Adnan Menderes University
    ClinicalTrials.gov Identifier:
    NCT03718689
    Other Study ID Numbers:
    • 2018-048
    First Posted:
    Oct 24, 2018
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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

    Study Results

    No Results Posted as of Feb 17, 2020