Effect of Caffeic Acid Phenethyl Ester as a Matrix Metalloproteinase Inhibitor: Randomized Controlled Clinical Trial
Condition: Matrix Metalloproteinase Inhibitors; Composite Resins
Study type: Interventional

Summary: 
      Matrix metalloproteinases (MMPs); activated by the application of adhesive systems on dentin
      cause degradation of the collagen proteins and loss of bond strength in adhesive
      restorations. Caffeic acid phenethyl ester (CAPE) showed inhibitory activities on dentinal
      MMPs. It is hypothesised that dentin pretreatment with CAPE, as an MMP inhibitor, would be
      beneficial for the bonding of resin material and tooth substrate over the course of time.
      This study evaluated the effect of 5 % CAPE pretreatment on the microtensile bond strength of
      a nanohybrid resin restoration applied with total-etch or self-etch adhesive systems on 10
      patients (12-18 yrs). Two standard cavities (3 x 3 x 4 mm) prepared on the occlusal surfaces
      of one of the two premolar teeth in each patient were randomly assigned into four treatment
      groups (n=10); 5% CAPE pretreatment and total-etch adhesive (TC), Total-etch adhesive
      (control) (T), 5% CAPE pretreatment and self-etch adhesive (SC), Self-etch adhesive (control)
      (S) followed by restoration and 3 months of intra-oral functioning. After teeth extraction,
      the specimens were stored in distilled water+thymol solution at 4°C to inhibit microbial
      growth and used in one week period. Dentin-composite sticks were obtained from each
      restoration for µTBS tests and scanning electron microscopy (SEM) evaluation. Failure mode
      analysis was performed microscopically. Data were analysed statistically using Repeated
      Measure ANOVA (p < 0.05). Dentin pretreatment with CAPE solution (5%) for 60 seconds
      significantly increased the composite resin restorations' bond strengths to dentin applied
      with either total-etch or self-etch adhesive system. Thus it can be used as an MMP inhibitor
      prior to the the resin restorations. However further long term clinical studies are needed to
      support the use of CAPE pretreatment along with self-etch and total-etch adhesive systems.
    

Detailed description: 
      The aim of the present study was to evaluate the effect of caffeic acid phenethyl ester
      (CAPE) pretreatment used as matrix metalloproteinase (MMP) inhibitor on microtensile bond
      strength (µTBS) of nanohybrid resin restorations applied with total-etch or self-etch
      adhesive systems. A total of 10 patients aged between 12 and 18 years old (4 males, 6
      females, mean age:15) received 40 composite restorations. The patients who had contralateral
      pairs of caries-free premolars which were planned to be extracted for orthodontic treatment
      were enrolled in the study. This study was performed with a protocol approved by the Ethical
      Committee for Clinical Studies, Faculty of Medicine, University of Ege, Izmir, Turkey
      (04.10.2012; no:12-8/6). The treatments were performed after the informed consents were
      received both from the parents and the patients. Included teeth were in function and no
      anomalies were found neither in teeth nor in occlusion. Two standard cavities (3 x 3 x 4 mm)
      with continuous enamel cavosurface margins were prepared on the occlusal surfaces of each
      premolar tooth.Totally four cavities in each patient were randomly assigned into four
      treatment groups (n=10); Group TC: CAPE and total-etch adhesive (Syntac; Ivoclar Vivadent
      AG), Group T: Total-etch adhesive (control), Group SC: CAPE and self-etch adhesive (AdheSE;
      Ivoclar Vivadent AG), Group S: Self-etch adhesive (control). All cavities were restored
      incrementally with a nano-filled hybrid composite resin (Tetric-N-Ceram, Ivoclar Vivadent AG)
      in which polymerization in each layer was performed for 40 seconds with a light-curing unit
      (BluePhase Ivoclar Vivadent AG) exceeding an energy output of 500mw/sec.
    

Intervention name(s): total-etch adhesive; CAPE-T; self-etch adhesive; CAPE-S
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): comparator use of total-etch adhesive; experimental group; comparator use of total-etch adhesive; experimental group
Other intervention name(s): adhesive; CAPE solution; adhesive; CAPE solution
Intervention MeSH terms: Capecitabine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention