Efficacy and Retention of Sealants Placement Using Two Isolation Systems
Condition: Retention; Time; Patient Preference
Study type: Interventional

Summary: 
      The trial aimed to evaluate the sealant retention, patient's preference and chair time needed
      during pit and fissure sealant placement under two isolation techniques [Dryshield system
      (DS) and cotton roll isolation (CRI)] in a university setting.
    

Detailed description: 
      In children, 80-90% of dental caries is found in the pits and fissures of the posterior
      permanent teeth. Pit and fissure sealants (PFS) can be used effectively to prevent dental
      caries. When applied correctly, dental PFS accomplish three main objectives: preventing
      dental caries development, hindering dental caries development in its initial phases, and
      inhibiting the spread of bacteria that cause dental caries. To be effective, PFS need to be
      applied under sufficient moisture control around the specific teeth undergoing treatment.
      Therefore, proper isolation of the teeth is one of the most important steps when placing
      sealants to ensure their retention.

      Cotton roll isolation (CRI) has been widely used for sealant placement, and is the most
      common method among pediatric dentists. However, the placement of cotton rolls on the lateral
      part of the tongue or inadequate isolation during CRI has both been reported to produce
      gagging, tasting the contents and requiring frequent replacement of the wet cotton rolls.

      A previous study demonstrated that new moisture control systems such as Isolite, produce
      sealant retention rates comparable to cotton roll isolation, while decreasing procedure time.
      DryShield (DS) has recently been introduced as an all-in-one isolation system. It is similar
      to the Isolite as it combines the tasks of fluid evacuation, tongue and cheek retraction, and
      serves as a bite block, but differs in that it is autoclavable and does not provide
      illumination. Its design allows it to suction and isolate half the oral cavity at a time.
      Therefore, it should presumably facilitate sealants placement under a more controlled
      environment, while reducing chair time for the dentist.

      Few trials have compared the PFS chair time and patient acceptance of DS to the CRI. The
      goals of this study were to evaluate patients' preferences, time efficiency, and retention of
      PFS using DS compared to CRI in a single randomized clinical study.
    

Intervention name(s): Dryshield; Cotton roll isolation
Intervention type(s): Device; Device
Intervention description(s): DryShield combines the tasks of high-suction evacuator, saliva ejector, bite block, tongue shield, and oral pathway protector in one easy-to-use device.
The DryShield solution® is a patented autoclavable isolation system (MA, USA); Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.
Other intervention name(s): Cotton roll
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All eligible study participants were randomised using simple block random allocation to ensure balanced randomization for each isolation system. Each participant was given an envelope and a printed participant number. Each number identified the isolation technique used for sealant placement and the isolation application sequence to be used.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention