A Clinical Trial to Assess the Retention and Caries Preventive Effect of Resin Based Sealants Versus ART Sealants
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background and study aims:

      The investigators are carrying out a clinical trial of two different sealant materials to
      compare the retentivity and decay inhibiting properties of the above said materials. it is a
      split mouth study, wherein the 2 sealant materials will be placed on the exactly opposite
      placed molars of 198 healthy school children in the age group between 6 - 12 yrs of age.

      who can participate? school children in the age group between 6 - 12 yrs of age with non
      decayed contra lateral permanent 1st molars at a school in the southern part of India.

      what does the study involve? over a period of 24 months, the retentivity and the decay
      preventing effects of these two sealant materials( RESIN BASED SEALANTS AND ART SEALANTS)
      will be clinically assessed by us.

      possible benefits/ risks of participating in the trial the participants will be not be
      exposed to any kind of risks as it is a non invasive procedure the possible benefits may be
      preventing decay to the permanent molar in the long run

      study start date/duration of the study? MARCH 2015 is the month wherein the sealant
      applications have started and expected to last till the April of 2017

      funding? self funded study
    

Detailed description: 
      Pits and fissures in the first molars are the most susceptible sites for dental caries in the
      permanent dentition and contemporary studies show specifically that 85% or more of the caries
      is nested in the above-mentioned sites . Thus, prevention of caries in these tooth sites is
      of crucial importance in keeping a sound permanent dentition.

      Sealing the pits and fissures of molars and premolars for prevention of dental caries was
      first introduced in the 1960s . It is now accepted as a highly effective method in preventing
      dental caries .

      Prominently, there are basically two types of sealant materials..i.e resin based sealants
      which are flowable composite resins and Glass ionomer based sealants. Reading through the
      literature, it is well understood that the resin based sealants are more retentive than the
      GIC based sealants mainly because the enamel surface is etched prior to the placement and it
      is dispensed through syringes, thereby it generally adapts well to the surfaces. GIC sealants
      are known to be equally effective when to comes to caries prevention, but generally are far
      less retentive than the resin based sealants. the main issue regarding the placement of resin
      based sealants is that it is a cumbersome procedure requiring strict isolation. Looking at a
      dental public health point of view, especially in a country like India, the use of resin
      based sealants at outreach centres will be a problem because of the lack of adequate
      infrastructure.

      To counter the limited applicability of resin based sealants in a field setting, the use of a
      high viscosity GIC sealant is advocated here. The high viscosity GIC sealant has a better
      compressive strength to take on the occlusal stress and thereby it is expected that the
      retention of the ART sealant (High viscous GIC sealant) using the ART technique (finger press
      technique) would be better than the conventional GIC based sealants. Till date, a very
      limited number of studies have been performed on the comparison between the ART sealant and
      the resin based sealant( gold standard) and thereby, this study has been conceived to assess
      the retentivity and the caries preventive effect of the above two systems.

      The null hypothesis states that there is no expected difference between resin based sealants
      and ART sealants

      Based on the statistical analysis, the sample size for this study has been estimated to be
      198 subjects. ethical clearance has been obtained from the IRB of the dental school and
      informed consent obtained from all the participating subjects. This is a spilt mouth study,
      wherein on side, resin based sealants are placed and on the other side, the ART sealants are
      placed. All the participating 198 subjects do have a caries free lower permanent lower 1st
      right and left molars.

      The sealants are placed according to the manufacturer s instructions. after placements, the
      retention and the caries preventive effects are followed up progressively for a period of 24
      months.
    

Intervention name(s): Helioseal - F; ART sealant
Intervention type(s): Other; Other
Intervention description(s): Helioseal -F ( Resin based sealant)
isolate the tooth surface
etch the fissure anatomy with 37% phosphoric acid for 20 seconds
wash the tooth surface and dry it. No salivary contamination is accepeted
using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment.
light cure the sealant
check for high points and the occlusion; Fuji IX extra strength
isolate the tooth surface
condition the fissure anatomy using a GC conditioner for 10 seconds
wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe.
dry the tooth surface
mix the GIC according to the standard powder: liquid ratio
place the mix onto the fissures using a plastic spatula
apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly)
apply pressure for 10-15 sec and withdraw the finger in a sideways motion
scrap out the excess material
check for the high points and the occlusion
apply petroleum jelly onto the GIC mix
advice patient not to eat or drink for 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention