Comparison of the success Rate of microFilled and nanofilled resin-based fissure sealants: A randomised control trial

To compare and evaluate the clinical efficiency of two pit and fissure sealants (Microfilled and Nanofilled based) on Permanent mandibular molars in 6-12 year old children.

 Since, the application of nanomaterials and functional fillers in dentistry has evolved due to the development of nanotechnology. There is a wide range of microfilled pit and fissure sealants and recently introduced nanofilled pit and fissure sealants available in the market, however, currently, there is limited availability of nano based dental sealants in India. Thus, a dire need arises for development and applicability of an Indian based nano technology based dental sealant. E-pit and Fissure sealant (Kids e- dental, LLP, India), newer silver containing nano resin based dental sealant. It mainly consists of UDMA resin with micronized GIC and silver, thereby making this newer dental product suitable for sealing pits and fissures, antimicrobial action, caries arrest and remineralisation. The newer product has received necessary regulatory body’s approval and free market sale certificate respectively.

 Keeping in mind the sample attrition, a  total of 144 (72 each )  mandibular permanent first molar teeth with stained/ deep pits and fissures will be selected in healthy children aged 6-12 years reporting to the Department of Paedodontics and Preventive Dentistry. Patients who are medically compromised, children with developmental defects/hypoplastic molars or caries affected teeth, teeth with restorations or partially retained sealant restorations, and partially erupted teeth will be excluded.

Written informed consent will be obtained from parents of all children participating in the study. Ethical clearance to conduct the study was obtained from the Institutional Review Board of Sudha Rustagi College of Dental Sciences and Research, Faridabad. A split mouth type of study will be designed, in which each side of the mouth will be assigned to a test agent; Group I- Fissurit FX fissure sealant (Voco, Germany) and; Group II- E-sealant using a coin toss method.

All the sealants will be placed in a dental clinic setting by a single operator working with proper illumination. Isolation will be carried out using a rubber dam with adequate suctioning to remove saliva from the operating field. A slurry of pumice and a rotating pointed bristle brush at slow speed will be used to clean the teeth and then rinsed  and air dried thoroughly. Etchant containing 37% phosphoric acid will be applied to the pits and fissures extending 1/3rd of the cuspal inclines for 30 seconds, washed thoroughly, and dried. After Dull frosty white appearance of the enamel. Fissure sealant will be gradually applied and flown along the fissures into the probe. The sealant will be immediately light cured after their placement by a 20 second exposure using light curing unit as per the manufacturer’s instructions. The sealed teeth will be checked for high points with articulating paper. Excess material will be removed using a small round finishing bur at a low speed. Patients will be informed not to eat or consume any fluids or eat for 30 minutes after the sealant placement. The entire procedure will be cross-checked by co-investigator to avoid any procedural errors and to ensure adequate sealing of teeth. The second examiner will be unaware of the different groups to avoid any bias. The sealants will be applied only once at the beginning of the study. Repair or replacement of insufficient sealants will not be attempted during the follow-up period. The sealed teeth will be evaluated clinically by co-investigators at 3 and, 6 months of interval using modified USPHS criteria.