A Clinical Trial to Assess the Retention and Caries Preventive Effects of Moisture Tolerant Resin Sealant and ART Sealants
Condition: Retention
Study type: Interventional
Phase: Phase 3

Summary: 
      It is a clinical trial which employs a split mouth design to assess the retention of a
      moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants
      on a representative sample of 7- 12 year old school children of a district in Belgaum,
      Karnataka, India.
    

Detailed description: 
      Dental caries is a diet dependent, transmissible, micro biologically mediated disease, which
      follows both an infectious and chronic disease model that progresses slowly with periods of
      quiescence.

      From the literature available, it is understood that although dental caries is on the decline
      in many of the developed countries, it still remains unchanged with regards to pits and
      fissure caries of occlusal surfaces of the teeth. This increase in susceptibility is due to
      its inherent morphological structure which makes a person unable to maintain cleanliness
      devoid of food lodgement.. Although pits and fissures of occlusal surfaces form only 12.5% of
      all tooth surfaces yet, they constitute more than 2/3rd of total caries experience among
      young permanent teeth.

      The prevention of dental caries not only includes measures to prevent the occurrence of
      disease, such as risk factor reduction, but also to arrest the progress of disease and reduce
      the consequences of disease once it is established Creativity in this effort against fissure
      caries continues, with newer materials and technology tested each year. The traditional
      preventive methods, such as diet control and fluoride therapy effectively prevent dental
      caries on smooth tooth surfaces, but they have not been satisfactory methods to control
      caries in pit and fissures.

      At the time that acid etch bonding was first described by Buonocore in 1955 , bonding was a
      new technology, and a logical step in its use was the prevention of pit and fissure decay.
      The focus of Buonocore's work was the development of a sealant to prevent occlusal caries on
      posterior teeth.Thus, resin sealants were born. Acid treatment of enamel or dentin, whether a
      priory or concomitant bonding step, has been integrated into methods to retain materials and
      significantly reduce micro leakage at material tooth interfaces.

      Pit and fissure sealant is a "cement or resin material which is introduced into unprepared
      occlusal pit and fissure of caries susceptible teeth, forming a mechanical and physical
      protective layer against the action of acid producing bacteria and their substrate".

      Pit and fissure sealants introduced by Cueto and Buonocore in 1967 have been accepted as an
      efficient caries preventive method. For most of the period since the introduction of the
      sealants, the focus has been on Bis-GMA resin based materials. Resin based sealants have been
      tested on many occasions and have generally been shown to be an effective method of caries
      prevention for children and young adults,. The efficacy of these resin sealants in preventing
      caries has been associated with the duration and degree of sealant retention.

      However, the application of resin based sealants demands total moisture control as they are
      hydrophobic in nature and is often only possible to a limited extent particularly in children
      with low compliance. Ideally, a material combining the attributes of resin based sealants,
      such as good retention and good physical properties with moisture tolerance would be
      desirable.

      Recently, a unique moisture tolerant resin based sealant called the embrace wet bond sealant
      has been introduced. Embrace incorporates di-tri and multi-functional acrylate monomers into
      an advanced acid integrating chemistry that is activated by moisture. The advantages are wet
      bonding, tooth integrating, better retention, superior marginal seal, less technique
      sensitive and increased fluoride release.

      Another class of sealants that have been developed are the glass inomer based sealants and
      these are primarily indicated for subjects, where in total moisture control is not
      achievable. These sealants, although being hydrophilic have a major drawback which is the low
      retentivity. In order to overcome this drawback, high viscosity glass inomer cements using
      the ART approach have been introduced as sealant materials.

      A notable point which has been to be given further consideration is the fact that although
      the embrace wet bond sealant (resin based sealant) and the ART sealant (GIC based sealant)
      belong to different classes of sealants, they can be indicated in conditions where total
      moisture control is impossible to achieve.

      There is an absolute lack of information regarding the relative performance of the moisture
      tolerant resin based sealant (embrace wet bond sealant) against the ART sealants and
      therefore this clinical trial will evaluate the retention and the caries preventive aspect of
      the above said materials among a representative sample of 7- 10 year old caries prone
      children.
    

Intervention name(s): ART Sealant Application; Resin sealant application
Intervention type(s): Other; Other
Intervention description(s): application of the ART sealant using high viscosity glass inomer cements.; application of the moisture tolerant sealant according to the manufacturers instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention