Clinical Evaluation of Giomer and Resin-based Fissure Sealants

Molar Incisor Hypomineralization Clinical Trial

Official title:

Clinical Evaluation of Giomer and Resin-based Fissure Sealants Performed in Permanent Molar Teeth Affected by Molar-Incisor Hypomineralization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929782
• Other study ID #: HUDHF-MIH-fissureselant
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: June 2021
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 20, 2020
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralization

Intervention

Device:
• Resin-based sealant
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, Benlioglu Dental Inc, Turkey) for 20s on each surface.
• Giomer sealants
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, Benlioglu Dental Inc, Turkey) for 20 s on each surface.

Locations

Country	Name	City	State
Turkey	Hacettepe University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Fragelli CMB, Souza JF, Bussaneli DG, Jeremias F, Santos-Pinto LD, Cordeiro RCL. Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up. Braz Oral Res. 2017 Apr 27;31:e30. doi: 10.1590/1807-3107BOR-2017.vol31.0030. — View Citation

Lygidakis NA, Dimou G, Stamataki E. Retention of fissure sealants using two different methods of application in teeth with hypomineralised molars (MIH): a 4 year clinical study. Eur Arch Paediatr Dent. 2009 Dec;10(4):223-6. — View Citation

Weerheijm KL, Jälevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance evaluation using USPHS Criteria	Clinical evaluation was performed by two blinded examiners in accordance with the modified-USPHS criteria, to assess anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries at 1, 3, 6 and 12 months	12 months