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pHSB: Carbonated Beverage Consumption in pH and Bacterial Proliferation

Sponsor
Hospital Infantil de Mexico Federico Gomez (Other)
Overall Status
Completed
CT.gov ID
NCT05437874
Collaborator
(none)
18
Enrollment
1
Location
4
Arms
17.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Natural Water
 Phase 1

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

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A Randomized Crossover Clinical TrialA Randomized Crossover Clinical Trial
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
colors were designated for each drink
Primary Purpose:
Basic Science
Official Title:
Effects of Carbonated Beverage Consumption on Oral pH and Bacterial Proliferation in Adolescents: A Randomized Crossover Clinical Trial.
Actual Study Start Date :
Jan 18, 2018
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Jul 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Natural Water

355 ml of 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

Drug: Natural Water
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

    		•
    Active Comparator: Carbonated water

    355 ml of carbonated 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

    Drug: Natural Water
    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

    		•
    Experimental: Aspartame/acesulfame K

    355 ml of drink of diet coke 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

    Drug: Natural Water
    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

    		•
    Experimental: Saccharose

    355 ml of drink of regular coke 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

    Drug: Natural Water
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean salivary pH with regular coke [0 minutes]

      Logarithm of hydrogen ion concentration

    2. Mean salivary pH with regular coke [5 minutes]

      Logarithm of hydrogen ion concentration

    3. Mean salivary pH with regular coke [10 minutes]

      Logarithm of hydrogen ion concentration

    4. Mean salivary pH with regular coke [15 minutes]

      Logarithm of hydrogen ion concentration

    5. Mean salivary pH with regular coke [30 minutes]

      Logarithm of hydrogen ion concentration

    6. Mean salivary pH with regular coke [45 minutes]

      Logarithm of hydrogen ion concentration

    7. Mean salivary pH with regular coke [60 minutes]

      Logarithm of hydrogen ion concentration

    8. Mean salivary pH with diet coke [0 minutes]

      Logarithm of hydrogen ion concentration

    9. Mean salivary pH with diet coke [5 minutes]

      Logarithm of hydrogen ion concentration

    10. Mean salivary pH with diet coke [10 minutes]

      Logarithm of hydrogen ion concentration

    11. Mean salivary pH with diet coke [15 minutes]

      Logarithm of hydrogen ion concentration

    12. Mean salivary pH with diet coke [30 minutes]

      Logarithm of hydrogen ion concentration

    13. Mean salivary pH with diet coke [45 minutes]

      Logarithm of hydrogen ion concentration

    14. Mean salivary pH with diet coke [60 minutes]

      Logarithm of hydrogen ion concentration

    15. Mean salivary pH with carbonated water [0 minutes]

      Logarithm of hydrogen ion concentration

    16. Mean salivary pH with carbonated water [5 minutes]

      Logarithm of hydrogen ion concentration

    17. Mean salivary pH with carbonated water [10 minutes]

      Logarithm of hydrogen ion concentration

    18. Mean salivary pH with carbonated water [15 minutes]

      Logarithm of hydrogen ion concentration

    19. Mean salivary pH with carbonated water [30 minutes]

      Logarithm of hydrogen ion concentration

    20. Mean salivary pH with carbonated water [45 minutes]

      Logarithm of hydrogen ion concentration

    21. Mean salivary pH with carbonated water [60 minutes]

      logarithm of hydrogen ion concentration

    22. Mean salivary pH with natural water [0 minutes]

      Logarithm of hydrogen ion concentration

    23. Mean salivary pH with natural water [5 minutes]

      Logarithm of hydrogen ion concentration

    24. Mean salivary pH with natural water [10 minutes]

      Logarithm of hydrogen ion concentration

    25. Mean salivary pH with natural water [15 minutes]

      Logarithm of hydrogen ion concentration

    26. Mean salivary pH with natural water [30 minutes]

      Logarithm of hydrogen ion concentration

    27. Mean salivary pH with natual water [45 minutes]

      Logarithm of hydrogen ion concentration

    28. Mean salivary pH with natural water [60 minutes]

      Logarithm of hydrogen ion concentration

    Secondary Outcome Measures

    1. Mean dental biofilm pH with regular coke [0 minutes]

      Logarithm of hydrogen ion concentration

    2. Mean dental biofilm pH with regular coke [5 minutes]

      Logarithm of hydrogen ion concentration

    3. Mean dental biofilm pH with regular coke [10 minutes]

      Logarithm of hydrogen ion concentration

    4. Mean dental biofilm pH with regular coke [15 minutes]

      Logarithm of hydrogen ion concentration

    5. Mean dental biofilm pH with regular coke [30 minutes]

      Logarithm of hydrogen ion concentration

    6. Mean dental biofilm pH with regular coke [45 minutes]

      Logarithm of hydrogen ion concentration

    7. Mean dental biofilm pH with regular coke [60 minutes]

      Logarithm of hydrogen ion concentration

    8. Mean dental biofilm pH with diet coke [0 minutes]

      Logarithm of hydrogen ion concentration

    9. Mean dental biofilm pH with diet coke [5 minutes]

      Logarithm of hydrogen ion concentration

    10. Mean dental biofilm pH with diet coke [10 minutes]

      Logarithm of hydrogen ion concentration

    11. Mean dental pH biofilm with diet coke [15 minutes]

      Logarithm of hydrogen ion concentration

    12. Mean dental biofilm pH with diet coke [30 minutes]

      Logarithm of hydrogen ion concentration

    13. Mean dental biofilm pH with diet coke [45 minutes]

      Logarithm of hydrogen ion concentration

    14. Mean dental biofilm pH with diet coke [60 minutes]

      Logarithm of hydrogen ion concentration

    15. Mean dental biofilm pH with carbonated water [0 minutes]

      Logarithm of hydrogen ion concentration

    16. Mean dental biofilm pH with diet carbonated water [5 minutes]

      Logarithm of hydrogen ion concentration

    17. Mean dental biofilm pH with carbonated water [10 minutes]

      Logarithm of hydrogen ion concentration

    18. Mean dental biofilm pH with carbonated water [15 minutes]

      Logarithm of hydrogen ion concentration

    19. Mean dental pellicle pH with carbonated water [30 minutes]

      Logarithm of hydrogen ion concentration

    20. Mean dental biofilm pH with carbonated water [45 minutes]

      Logarithm of hydrogen ion concentration

    21. Mean dental biofilm pH with carbonated water [60 minutes]

      Logarithm of hydrogen ion concentration

    22. Mean dental biofilm pH with natural water [0 minutes]

      Logarithm of hydrogen ion concentration

    23. Mean dental biofilm pH with natural water [5 minutes]

      Logarithm of hydrogen ion concentration

    24. Mean dental biofilm pH with natural water [10 minutes]

      Logarithm of hydrogen ion concentration

    25. Mean dental biofilm pH with natural water [15 minutes]

      Logarithm of hydrogen ion concentration

    26. Mean dental biofilm pH with natural water [30 minutes]

      Logarithm of hydrogen ion concentration

    27. Mean dental biofilm pH with natural water [45 minutes]

      Logarithm of hydrogen ion concentration

    28. Mean dental biofilm pH with natural water [60 minutes]

      Logarithm of hydrogen ion concentration

    Other Outcome Measures

    1. Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke [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 [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 [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 [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 [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 [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 [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 [120 minutes]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children´s Hospital of Mexico Federico Gómez Mexico City Mexico 06720

    Sponsors and Collaborators

    • Hospital Infantil de Mexico Federico Gomez

    Investigators

    • Study Director: Juan Garduño, MSc., PhD, Children´s Hospital of Mexico Federico Gómez

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Guadalupe Barajas, Principal Investigator, Hospital Infantil de Mexico Federico Gomez
    ClinicalTrials.gov Identifier:
    NCT05437874
    Other Study ID Numbers:
    • HIM 2017-084 SSA 1411
    First Posted:
    Jun 29, 2022
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Guadalupe Barajas, Principal Investigator, Hospital Infantil de Mexico Federico Gomez
    pH
    caries
    saliva
    artificial sweetener
    carbonated beverages
    dental biofilm
    Additional relevant MeSH terms:
    Dental Plaque

    Study Results

    No Results Posted as of Jun 29, 2022