- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718689
Effect of Er:YAG Laser on Hydrophilic Sealants
February 13, 2020 updated by: SULTAN KELES, Aydin Adnan Menderes University
The Effect of Er:YAG Laser on Clinical Success of a Hydrophilic Fissure Sealant
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydın, Turkey, 09100
- Hülya Yılmaz
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group L
The second group of teeth (Group L) were etched with Er:YAG laser.
|
Acid etching
Other Names:
|
Experimental: Group A+L
The third group of teeth (Group A+L) were etched with both Er:YAG laser and phosphoric acid.
|
Acid etching
Other Names:
|
No Intervention: Group A
The first group of teeth (Group A) were not etched with Er:YAG laser.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention rate
Time Frame: Change from Baseline retention rate at 12 months
|
Clinical success
|
Change from Baseline retention rate at 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
October 15, 2018
Study Registration Dates
First Submitted
October 22, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2018-048
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The results will be shared with other researchers.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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