Clinical trial NCT04929782: Clinical Evaluation of Giomer and Resin-based Fissure Sealants
Official title: Clinical Evaluation of Giomer and Resin-based Fissure Sealants Performed in Permanent Molar Teeth Affected by Molar-Incisor Hypomineralization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: molar incisor hypomineralization
giomer fissure sealants
resin sealants
adhesion
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 57
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two intervention groups and split-mouth design
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical performance evaluation using USPHS Criteria
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altindag
Study officials:
References:
citation: Weerheijm KL, Jalevik B, Alaluusua S. Molar-incisor hypomineralisation. Caries Res. 2001 Sep-Oct;35(5):390-1. doi: 10.1159/000047479. No abstract available.
citation: 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.
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. doi: 10.1007/BF03262686.
citation: Ozgur B, Kargin ST, Olmez MS. Clinical evaluation of giomer- and resin-based fissure sealants on permanent molars affected by molar-incisor hypomineralization: a randomized clinical trial. BMC Oral Health. 2022 Jul 5;22(1):275. doi: 10.1186/s12903-022-02298-9.