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Carbonated Beverage Consumption in pH and Bacterial Proliferation

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05437874
Acronym
pHSB
Enrollment
18
Registered
2022-06-29
Start date
2018-01-18
Completion date
2019-07-18
Last updated
2022-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Plaque, pH, Saliva

Keywords

pH, caries, saliva, artificial sweetener, carbonated beverages, dental biofilm

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.

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

Interventions

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

Sponsors

Hospital Infantil de Mexico Federico Gomez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

colors were designated for each drink

Intervention model description

A Randomized Crossover Clinical Trial

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Mean salivary pH with natual water45 minutesLogarithm of hydrogen ion concentration
Mean salivary pH with diet coke0 minutesLogarithm of hydrogen ion concentration
Mean salivary pH with natural water0 minutesLogarithm of hydrogen ion concentration
Mean salivary pH with carbonated water0 minutesLogarithm of hydrogen ion concentration
Mean salivary pH with regular coke0 minutesLogarithm of hydrogen ion concentration

Secondary

MeasureTime frameDescription
Mean dental pellicle pH with carbonated water30 minutesLogarithm of hydrogen ion concentration
Mean dental biofilm pH with natural water0 minutesLogarithm of hydrogen ion concentration
Mean dental biofilm pH with diet carbonated water5 minutesLogarithm of hydrogen ion concentration
Mean dental biofilm pH with regular coke0 minutesLogarithm of hydrogen ion concentration
Mean dental biofilm pH with diet coke0 minutesLogarithm of hydrogen ion concentration
Mean dental pH biofilm with diet coke15 minutesLogarithm of hydrogen ion concentration
Mean dental biofilm pH with carbonated water0 minutesLogarithm of hydrogen ion concentration

Other

MeasureTime frameDescription
Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke0 minutesNumber of viable colonies on a semisolid agar culture medium that are visible and separable.
Mean Colony Forming Units Streptococcus mutans dental biofilm with natural water0 minutesNumber of viable colonies on a semisolid agar culture medium that are visible and separable.
Mean Colony Forming Units Streptococcus mutans dental biofilm with carbonated water0 minutesNumber of viable colonies on a semisolid agar culture medium that are visible and separable.
Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke0 minutesNumber of viable colonies on a semisolid agar culture medium that are visible and separable.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026