Carbonated Beverage Consumption in pH and Bacterial Proliferation
Condition: pH; Saliva; Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this research is to evaluate the oral modifications caused by different
      types of coke drinks (regular coke and diet coke). The salivary and the dental biofilm pH
      will be determined in the first minutes after their consumption. Additionally, the bacterial
      proliferation of dental biofilm will be evaluated.
    

Detailed description: 
      Sugary soft drinks modify oral pH and favor bacterial proliferation and are associated with
      the development of caries. Information on the effects of consuming carbonated drinks without
      sucrose is limited.

      In this crossover clinical trial, salivary pH and dental biofilm pH will be determined. These
      will be registered at 0, 5, 10, 15, 30, 45, and 60 min after the participants ingested 355 ml
      of natural water, soft drink with sucrose, soft drink with aspartame/acesulfame K or
      carbonated water on different days (1 week between each other). In addition, dental biofilm
      cultures will be conducted at 0 and 120 minutes after intake of each beverage to determine
      Streptococcus mutans biofilm formation.

      The patients will be invited to participate and informed of the potential risks. Those who
      signed informed consent and have eligibility requirements will be randomized in a
      double-blind manner.

      The data collection will be carried out in records forms, including verifying the patient's
      previous conditions, identification data (ID, age, gender,) and possible adverse events. If
      any adverse effect could exist, the research team will be notified for the implementation of
      possible changes.

      A HANNA HI 221 potentiometer (HANNA Instruments Inc. Woonsocket-RI-USA, Romania) will be used
      to determine salivary pH and dental biofilm pH. The electrode will be calibrated using buffer
      solutions of pH 4.0 and 7.0 for correct records. The electrode will be washed with distilled
      water before and after each sample. The data will be collected by 2 verifiers, guaranteeing
      that the information obtained is the same as that indicated on the potentiometer; a stopwatch
      will indicate the exact time for obtaining the pH values.

      Samples of dental biofilm will be taken, and Streptococcus mutans biofilm formation will be
      evaluated at 0 and 120 minutes after taking each beverage. The samples will be cultivated in
      suitable conditions, identified and compared with ATCC. The samples obtained will be analyzed
      in the same place of collection to avoid possible contamination.

      Sample size with an alpha=0.05 and a beta=0.8 include 22, considering 20% losses.

      Variables will be described with frequencies and percentages or medians and interquartile
      range (IQR) according to the variable type. Salivary pH and dental biofilm at different times
      will be compared using ANOVA analysis with adjustment for multiple comparisons using
      Bonferroni correction. Changes in the bacterial proliferation of the dental biofilm at 0 and
      120 min will be compared using the Wilcoxon test and intergroup changes will be compared
      using the Kruskal-Wallis test. The statistical program SPSS v. 22 will be used and
      statistical significance will be considered with a p ≤ 0.05
    

Intervention name(s): Natural Water
Intervention type(s): Drug
Intervention description(s): 355 ml of regular coke, diet coke or mineral water should be drunk.
Salivary pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later
Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be conducted at 0 and 120 minutes later
Other intervention name(s): Plain water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A Randomized Crossover Clinical Trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: pH; caries; saliva; artificial sweetener; carbonated beverages; dental biofilm