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Completed

NCT Number: NCT05437874

Carbonated Beverage Consumption in pH and Bacterial Proliferation

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children´s Hospital of Mexico Federico Gómez

Mexico City, 06720, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Habitual consumption of soft drinks
  • DMFT (Decayed, Missing, and Filled Teeth) index of at least 3
  • Agree to participate in the study and sign informed consent
  • Parents sign informed consent
  • Any nutritional condition

Exclusion criteria

  • Undergoing orthodontic treatment
  • Received a topical application of fluoride during the last 3 months
  • Having a motor disability that interfered with tooth brushing
  • Consuming drugs or being carriers of diseases that cause xerostomia
  • Being under antibiotic therapy during the study period
  • Having active periodontal infections.

Treatment and study plan

Natural Water

Drug

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 names: Plain water

Primary outcomes

  1. Mean salivary pH with regular coke

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  2. Mean salivary pH with regular coke

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  3. Mean salivary pH with regular coke

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  4. Mean salivary pH with regular coke

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  5. Mean salivary pH with regular coke

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  6. Mean salivary pH with regular coke

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  7. Mean salivary pH with regular coke

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

  8. Mean salivary pH with diet coke

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  9. Mean salivary pH with diet coke

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  10. Mean salivary pH with diet coke

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  11. Mean salivary pH with diet coke

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  12. Mean salivary pH with diet coke

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  13. Mean salivary pH with diet coke

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  14. Mean salivary pH with diet coke

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

  15. Mean salivary pH with carbonated water

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  16. Mean salivary pH with carbonated water

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  17. Mean salivary pH with carbonated water

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  18. Mean salivary pH with carbonated water

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  19. Mean salivary pH with carbonated water

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  20. Mean salivary pH with carbonated water

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  21. Mean salivary pH with carbonated water

    Time frame: 60 minutes

    logarithm of hydrogen ion concentration

  22. Mean salivary pH with natural water

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  23. Mean salivary pH with natural water

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  24. Mean salivary pH with natural water

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  25. Mean salivary pH with natural water

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  26. Mean salivary pH with natural water

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  27. Mean salivary pH with natual water

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  28. Mean salivary pH with natural water

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

Secondary outcomes

  1. Mean dental biofilm pH with regular coke

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  2. Mean dental biofilm pH with regular coke

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  3. Mean dental biofilm pH with regular coke

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  4. Mean dental biofilm pH with regular coke

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  5. Mean dental biofilm pH with regular coke

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  6. Mean dental biofilm pH with regular coke

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  7. Mean dental biofilm pH with regular coke

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

  8. Mean dental biofilm pH with diet coke

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  9. Mean dental biofilm pH with diet coke

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  10. Mean dental biofilm pH with diet coke

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  11. Mean dental pH biofilm with diet coke

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  12. Mean dental biofilm pH with diet coke

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  13. Mean dental biofilm pH with diet coke

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  14. Mean dental biofilm pH with diet coke

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

  15. Mean dental biofilm pH with carbonated water

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  16. Mean dental biofilm pH with diet carbonated water

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  17. Mean dental biofilm pH with carbonated water

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  18. Mean dental biofilm pH with carbonated water

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  19. Mean dental pellicle pH with carbonated water

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  20. Mean dental biofilm pH with carbonated water

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  21. Mean dental biofilm pH with carbonated water

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

  22. Mean dental biofilm pH with natural water

    Time frame: 0 minutes

    Logarithm of hydrogen ion concentration

  23. Mean dental biofilm pH with natural water

    Time frame: 5 minutes

    Logarithm of hydrogen ion concentration

  24. Mean dental biofilm pH with natural water

    Time frame: 10 minutes

    Logarithm of hydrogen ion concentration

  25. Mean dental biofilm pH with natural water

    Time frame: 15 minutes

    Logarithm of hydrogen ion concentration

  26. Mean dental biofilm pH with natural water

    Time frame: 30 minutes

    Logarithm of hydrogen ion concentration

  27. Mean dental biofilm pH with natural water

    Time frame: 45 minutes

    Logarithm of hydrogen ion concentration

  28. Mean dental biofilm pH with natural water

    Time frame: 60 minutes

    Logarithm of hydrogen ion concentration

Other outcomes

  1. Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke

    Time frame: 0 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  2. Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke

    Time frame: 120 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  3. Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke

    Time frame: 0 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  4. Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke

    Time frame: 120 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  5. Mean Colony Forming Units Streptococcus mutans dental biofilm with carbonated water

    Time frame: 0 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  6. Mean Colony Forming Units Streptococcus mutans dental biofilm with carbonated water

    Time frame: 120 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  7. Mean Colony Forming Units Streptococcus mutans dental biofilm with natural water

    Time frame: 0 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

  8. Mean Colony Forming Units Streptococcus mutans dental biofilm with natural water

    Time frame: 120 minutes

    Number of viable colonies on a semisolid agar culture medium that are visible and separable.

Sponsors and collaborators

Lead sponsor

Hospital Infantil de Mexico Federico Gomez

Other

Registry information

Official study title

Effects of Carbonated Beverage Consumption on Oral pH and Bacterial Proliferation in Adolescents: A Randomized Crossover Clinical Trial.

Acronym: pHSB

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2022
Registry last updated
Jun 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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