Clinical trial NCT04854720: Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars
Official title: Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fissure Sealant
Keywords: Conventional glass ionomer
fissure sealant
giomer
laser fluorescence
newly erupted teeth
resin modified glass ionomer
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 182
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical retention rates, marginal adaptation, marginal discoloration and secondary caries formation of two different types of resin-modified glass ionomers (Fuji® II LC; Clinpro™ XT Varnish) and giomer-containing fissure sealant materials (Beautifil Flow) with glass ionomer-containing fissure sealant material (Fuji Triage®) used on newly erupted non-carious first permanent molars as a fissure sealant.

The study included 384 teeth belonging to 182 children, aged between 5 to 9 years old, who have two newly erupted mandibular permanent first molars.

Detailed description: Firstly, patients were randomly allocated to three main groups: Group 1; Fuji II LC/Fuji Triage (Control) (62 patients), Group 2; Clinpro XT Varnish/Fuji Triage (Control) (60 patients), Group 3; Beautifil Flow/Fuji Triage (Control) (60 patients). After clinical applications, all samples were evaluated in terms of retention, marginal adaptation, marginal discoloration and secondary caries formation using modified USPHS criteria in 6th, 12th and 18th months. Also samples were evaluated in terms of remineralization effect using the laser fluorescence method. Evaluations on occlusal and buccal surfaces were performed separately.

Eligibility criteria: Inclusion Criteria:

* Children who have two newly erupted non-carious mandibular permanent first molars that fissure sealant is indicated,
* Newly erupted first permanent molars show scores of 0 (Sound tooth surface)-1(First visual change in enamel) according to ICDAS II,
* Newly erupted first permanent molars show scores between 0-13 by using DIAGNOdent device,
* Children who haven't any systemic disease that prevents the application,
* Cooperative children who allowed the clinical applications.

Exclusion Criteria:

* Teeth with proximal and initial caries,
* Teeth with applied fissure sealant,
* Teeth with developmental defects such as hypoplasia and restorations,
* Non-cooperative children who don't allow the clinical applications,
* Children and parents who denied the participation in the follow-up appointments.

Primary outcomes:
measure: The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.
timeFrame: 18 months after the clinical applications
measure: The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.
timeFrame: 18 months after the clinical applications
measure: The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.
timeFrame: 18 months after the clinical applications
measure: The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.
timeFrame: 18 months after the clinical applications
Secondary outcomes:
measure: The assessment of remineralization capacity using DIAGNOdent device
timeFrame: 18 months after the clinical applications
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
affiliation: Izmir Katip Celebi Uni
name: Merve Akcay, assoc. prof.
role: STUDY_CHAIR
References: