Digital Radiography in Detection of Recurrent Caries Underneath Chlorhexidine Containing Adhesive Versus Conventional Adhesive After One Year Follow up: Randomized Clinical Trial
Condition: Recurrent Caries Incidence
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      This study will be conducted to compare the effect of chlorexidine containing adhesive versus
      conventional one in prevention of secondary caries lesion underneath composite restoration
      over one year follow up null hypothesis
    

Detailed description: 
      each patient will have at least 2 class II cavities.one will be restored using the
      intervention and the other using the control.

      Digital radiographs will be taken and the images will be processed using a digital system.
      Then the teeth will be evaluated by expert in dental radiology who had no awareness of the
      results of the visual inspection. The examiner will use a radiograph viewer and a
      radiographic film magnifier to determine the presence or absence of radiolucency underlying
      the restoration. The clinical and radiographic examination will be assessed according to the
      FDI World Dental Federation clinical criteria for the evaluation of direct and indirect
      restorations The aim of this equivalent trial is to examine if the chlorhexidine containing
      adhesive is effective as the conventional adhesive in prevention of recurrent caries under
      resin composite restoration after one year follow up in high caries risk patients with class
      II cavities. Based on the previous papers by Papagiannoulis et al .,1999 and kohler et
      al.,2000, the success rate reported was about 95% (absence of caries). If there is truly no
      difference between the standard and experimental treatment, then 37 patients are required to
      be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference
      between the standard and experimental group of more than 15 %. The sample size was calculated
      by sealed envelope online.

      Data will be analyzed using IBM SPSS advanced statistics (statistical package for social
      sciences), version 21 ( SPSS Inc. Chicago , IL). Numerical data will be described as mean and
      standard deviation or median and range. Categorical data will be described as numbers and
      percentages. Comparisons between categorical variables will be performed using the chi square
      test. An equivalent limit will be tested. A P -value less than or equal 0.05 will be
      considered statistically significant. All tests will be two tailed
    

Intervention name(s): adhesive bond with chlorhexidine; Time variable
Intervention type(s): Procedure; Other
Intervention description(s): Peak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries; Diagnosis and follow up will be immediate , 6 months later and 1 year
Other intervention name(s): peak universal bond
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention