Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars

NCT04854720 | Completed DMC

• 1 other identifier: 2018-TDU-DİŞF-0050
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Fissure Sealant

Keywords

Conventional glass ionomer; fissure sealant; giomer; laser fluorescence; newly erupted teeth; resin modified glass ionomer

Outcome Measures

Primary Outcomes (4)

• The assessment of clinical retention rates of fissure sealants applied to newly erupted permanent first molars.

  The primary outcome of the study was the assessment of clinical retention rates at 18th months.

  18 months after the clinical applications

• The assessment of marginal adaptation rates of fissure sealants applied to newly erupted permanent first molars.

  The primary outcome of the study was the assessment of marginal adaptation rates at 18th months.

  18 months after the clinical applications

• The assessment of marginal discoloration rates of fissure sealants applied to newly erupted permanent first molars.

  The primary outcome of the study was the assessment of marginal discoloration rates at 18th months.

  18 months after the clinical applications

• The assessment of secondary caries rates of fissure sealants applied to newly erupted permanent first molars.

  The primary outcome of the study was the assessment of secondary caries rates at 18th months.

  18 months after the clinical applications

Secondary Outcomes (1)

• The assessment of remineralization capacity using DIAGNOdent device

  18 months after the clinical applications

Study Arms (3)

Group 1 (Fuji II LC-Fuji Triage)

EXPERIMENTAL

In Group 1, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Fuji® II LC, GC Corporation, Tokyo, Japan) (test 1). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).

Device: Fuji® II LC CAPSULE; Device: Fuji Triage® CAPSULE

Group 2 (Clinpro XT Varnish-Fuji Triage)

EXPERIMENTAL

In Group 2, newly erupted mandibular permanent first molars were sealed with resin-modified glass ionomers containing fissure sealant material (Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA) (test 2). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).

Device: Clinpro™ XT Varnish; Device: Fuji Triage® CAPSULE

Group 3 (Beautiful Flow- Fuji Triage)

EXPERIMENTAL

In Group 3, newly erupted mandibular permanent first molars were sealed with Giomer containing fissure sealant material (Beautifil Flow, Shofu, Kyoto, Japan) (test 3). The other first molars were sealed with glass ionomers containing fissure sealant material (Fuji Triage®, GC Corporation, Tokyo, Japan) (control).

Device: Beautifil Flow; Device: Fuji Triage® CAPSULE

Interventions

Fuji® II LC CAPSULE DEVICE

Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth. Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions.

Also known as: Fuji® II LC CAPSULE, GC Corporation, Tokyo, Japan

Group 1 (Fuji II LC-Fuji Triage)

Clinpro™ XT Varnish DEVICE

Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products. Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions.

Also known as: Clinpro™ XT Varnish, 3M ESPE, St. Pauls, Miniapolis, MN, USA

Group 2 (Clinpro XT Varnish-Fuji Triage)

Beautifil Flow DEVICE

Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant. Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions.

Also known as: Beautifil Flow, Shofu, Kyoto, Japan

Group 3 (Beautiful Flow- Fuji Triage)

Fuji Triage® CAPSULE DEVICE

Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth. Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions.

Also known as: Fuji Triage® CAPSULE, GC Corporation, Tokyo, Japan

Group 1 (Fuji II LC-Fuji Triage); Group 2 (Clinpro XT Varnish-Fuji Triage); Group 3 (Beautiful Flow- Fuji Triage)

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, Turkey (Türkiye)

Location

Study Officials

• Merve Akcay, assoc. prof.

  Izmir Katip Celebi Uni

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization was performed by a computer-generated random sorting sequence (sealed in opaque envelopes that sequentially numbered randomly selected through).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: randomized controlled, three-arm parallel, single-blinded, split-mouth clinical trial

Study Record Dates

• First Submitted: April 18, 2021
• First Posted: April 22, 2021
• Study Start: March 10, 2019
• Primary Completion: November 16, 2020
• Study Completion: January 11, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)