NCT03718689

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

October 22, 2018

Last Update Submit

February 13, 2020

Conditions

Fissure Sealant

Outcome Measures

Primary Outcomes (1)

  • Retention rate

    Clinical success

    Change from Baseline retention rate at 12 months

Study Arms (3)

Group L

EXPERIMENTAL

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

Device: Laser etching

Group A+L

EXPERIMENTAL

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

Device: Laser etching

Group A

NO INTERVENTION

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

Interventions

Laser etchingDEVICE

Acid etching

Also known as: Acid
Group A+LGroup L

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hülya Yılmaz

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

  • Guclu ZA, Hurt AP, Donmez 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.

    PMID: 29236177RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.Dr.

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

January 1, 2018

Primary Completion

September 30, 2018

Study Completion

October 15, 2018

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

TU(1)