Clinical Evaluation of Giomer and Resin-based Fissure Sealants

Hacettepe University

Status: Completed

Conditions: Molar Incisor Hypomineralization

Treatments: Device: Resin-based sealant; Device: Giomer sealants

Study type: Interventional

Funder types: Other

Identifiers

NCT04929782

HUDHF-MIH-fissureselant

Details and patient eligibility

About

The objective of this research was to evaluate the clinical success of giomer and resin-based sealants applied in the first permanent molars (FPMs) affected by MIH.

Full description

One-hundred FPMs with MIH which were indicated for non-invasive fissure sealant were selected in 39 children (between 6-12 years). Using a split mouth design, the FPMs were randomized into two groups; Group 1: resin sealant (Conceal F); Group 2: giomer sealant (BeautiSealant) and dental isolation device was used during the procedure (Mr. Thursty). Clinical evaluation was performed by two blinded examiners using the United States Public Health Service (USPHS) criteria to assess anatomical form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months. Statistical analysis was performed using SPSS 20.0 software (IBM Corp., Chicago, IL, USA) and the level of significance was set at p<0.05. The association between independent variable (groups) and dependent variable (USPHS scores) was evaluated with Fisher's exact test. The crosstabulation of the categorical data regarding the groups were analyzed with chi-square test or Fisher's exact test. The Log-rank test and Kaplan-Meier analysis were used to calculate and compare the cumulative survival rates of the sealants.

Enrollment: 57 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy children, aged 6-12 years, who attended the pediatric dentistry clinic regular dental examination
• Cooperative children diagnosed with MIH according to European Academy of Paediatric Dentistry (EAPD) criteria
• Presenting at least two FPMs that were fully erupted and indicated for non-invasive fissure sealant.
• The FPMs with white, yellow or brown lesions, indicating mechanical and chemical alteration of the enamel and increased caries risk

Exclusion criteria

• Children having hypomineralized FPMs with post-eruptive breakdown, cavitated carious lesions, restorations or fixed orthodontic appliances
• Enamel defect due to a condition other than MIH

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Resin-based sealant

Active Comparator group

Description:

A dental isolation device was used (Mr. Thisty One Step, Zirc Dental, Buffalo, MN, USA) and the treatments were conducted by one operator according to following steps; Group 1: Etching with 37% phosphoric acid for 30 s (i-GEL N, i-dental, Lithuania), rinsing for 30 s with air-water spray and drying with oil-free air for 15 s, resin sealant (Conceal F, SDI, Australia) application into the occlusal and buccal/palatal pits and fissures with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20s on each surface.

Treatment:

Device: Resin-based sealant

Giomer sealant

Active Comparator group

Description:

Group 2: Self-etch primer (BeautiSealant Primer, Shofu, Japan) application to the occlusal and buccal/palatal pits and fissures with fine microbrush and waiting for 5 s, homogenizing the bond layer with gentle air stream for 5 s, giomer sealant application (BeautiSealant Paste, Shofu, Japan) with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20 s on each surface.

Treatment:

Device: Giomer sealants