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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03718689
Other study ID # 2018-048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date October 15, 2018

Study information

Verified date February 2020
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date October 15, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 7 Years to 11 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Laser etching
Acid etching

Locations

Country Name City State
Turkey Hülya Yilmaz Aydin

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Güçlü ZA, Hurt AP, Dönmez N, Coleman NJ. Effect of Er:YAG laser enamel conditioning and moisture on the microleakage of a hydrophilic sealant. Odontology. 2018 Jul;106(3):225-231. doi: 10.1007/s10266-017-0323-4. Epub 2017 Dec 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Retention rate Clinical success Change from Baseline retention rate at 12 months
See also
  Status Clinical Trial Phase
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Completed NCT02063815 - A Trial of Caries Prevention Effect of Fissure Sealants N/A
Recruiting NCT05336162 - Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant N/A
Active, not recruiting NCT03235960 - Efficacy of Glass-ionomer Fissure Sealants N/A