Carbonated Beverage Consumption in pH and Bacterial Proliferation (pHSB)

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

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.

Study Overview

• Status: Completed
• Conditions: pH; Dental Plaque; Saliva
• Intervention / Treatment: Drug: Natural Water

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06720
    • Children´s Hospital of Mexico Federico Gómez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	0 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	5 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	10 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	15 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	30 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	45 minutes
Mean salivary pH with regular coke	Logarithm of hydrogen ion concentration	60 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	0 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	5 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	10 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	15 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	30 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	45 minutes
Mean salivary pH with diet coke	Logarithm of hydrogen ion concentration	60 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	0 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	5 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	10 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	15 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	30 minutes
Mean salivary pH with carbonated water	Logarithm of hydrogen ion concentration	45 minutes
Mean salivary pH with carbonated water	logarithm of hydrogen ion concentration	60 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	0 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	5 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	10 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	15 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	30 minutes
Mean salivary pH with natual water	Logarithm of hydrogen ion concentration	45 minutes
Mean salivary pH with natural water	Logarithm of hydrogen ion concentration	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	0 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	5 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	10 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	15 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	30 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	45 minutes
Mean dental biofilm pH with regular coke	Logarithm of hydrogen ion concentration	60 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	0 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	5 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	10 minutes
Mean dental pH biofilm with diet coke	Logarithm of hydrogen ion concentration	15 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	30 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	45 minutes
Mean dental biofilm pH with diet coke	Logarithm of hydrogen ion concentration	60 minutes
Mean dental biofilm pH with carbonated water	Logarithm of hydrogen ion concentration	0 minutes
Mean dental biofilm pH with diet carbonated water	Logarithm of hydrogen ion concentration	5 minutes
Mean dental biofilm pH with carbonated water	Logarithm of hydrogen ion concentration	10 minutes
Mean dental biofilm pH with carbonated water	Logarithm of hydrogen ion concentration	15 minutes
Mean dental pellicle pH with carbonated water	Logarithm of hydrogen ion concentration	30 minutes
Mean dental biofilm pH with carbonated water	Logarithm of hydrogen ion concentration	45 minutes
Mean dental biofilm pH with carbonated water	Logarithm of hydrogen ion concentration	60 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	0 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	5 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	10 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	15 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	30 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	45 minutes
Mean dental biofilm pH with natural water	Logarithm of hydrogen ion concentration	60 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	0 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	120 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	0 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	120 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with carbonated water	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	0 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with carbonated water	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	120 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with natural water	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	0 minutes
Mean Colony Forming Units Streptococcus mutans dental biofilm with natural water	Number of viable colonies on a semisolid agar culture medium that are visible and separable.	120 minutes

Collaborators and Investigators

• Sponsor: Hospital Infantil de Mexico Federico Gomez
• Investigators: Study Director: Juan Garduño, MSc., PhD, Children´s Hospital of Mexico Federico Gómez

Publications and helpful links

General Publications

• Gonzalez-Aragon Pineda AE, Garcia Perez A, Garcia-Godoy F. Salivary parameters and oral health status amongst adolescents in Mexico. BMC Oral Health. 2020 Jul 6;20(1):190. doi: 10.1186/s12903-020-01182-8.
• Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
• Vieira AR, Modesto A, Marazita ML. Caries: review of human genetics research. Caries Res. 2014;48(5):491-506. doi: 10.1159/000358333. Epub 2014 May 21.
• Krzysciak W, Pluskwa KK, Piatkowski J, Krzysciak P, Jurczak A, Koscielniak D, Skalniak A. The usefulness of biotyping in the determination of selected pathogenicity determinants in Streptococcus mutans. BMC Microbiol. 2014 Aug 5;14:194. doi: 10.1186/1471-2180-14-194.
• Mathur MR, Tsakos G, Millett C, Arora M, Watt R. Socioeconomic inequalities in dental caries and their determinants in adolescents in New Delhi, India. BMJ Open. 2014 Dec 12;4(12):e006391. doi: 10.1136/bmjopen-2014-006391.
• Koo H, Falsetta ML, Klein MI. The exopolysaccharide matrix: a virulence determinant of cariogenic biofilm. J Dent Res. 2013 Dec;92(12):1065-73. doi: 10.1177/0022034513504218. Epub 2013 Sep 17.
• Gonzalez-Aragon Pineda AE, Borges-Yanez SA, Irigoyen-Camacho ME, Lussi A. Relationship between erosive tooth wear and beverage consumption among a group of schoolchildren in Mexico City. Clin Oral Investig. 2019 Feb;23(2):715-723. doi: 10.1007/s00784-018-2489-8. Epub 2018 May 13.
• Lemos JA, Palmer SR, Zeng L, Wen ZT, Kajfasz JK, Freires IA, Abranches J, Brady LJ. The Biology of Streptococcus mutans. Microbiol Spectr. 2019 Jan;7(1):10.1128/microbiolspec.gpp3-0051-2018. doi: 10.1128/microbiolspec.GPP3-0051-2018.
• Bechir F, Pacurar M, Tohati A, Bataga SM. Comparative Study of Salivary pH, Buffer Capacity, and Flow in Patients with and without Gastroesophageal Reflux Disease. Int J Environ Res Public Health. 2021 Dec 25;19(1):201. doi: 10.3390/ijerph19010201.
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• Ilie O, van Turnhout AG, van Loosdrecht MC, Picioreanu C. Numerical modelling of tooth enamel subsurface lesion formation induced by dental plaque. Caries Res. 2014;48(1):73-89. doi: 10.1159/000354123. Epub 2013 Nov 14.
• Humphrey SP, Williamson RT. A review of saliva: normal composition, flow, and function. J Prosthet Dent. 2001 Feb;85(2):162-9. doi: 10.1067/mpr.2001.113778.
• Kaur A, Kwatra KS, Kamboj P. Evaluation of non-microbial salivary caries activity parameters and salivary biochemical indicators in predicting dental caries. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):212-7. doi: 10.4103/0970-4388.105013.
• Ahmadi-Motamayel F, Falsafi P, Goodarzi MT, Poorolajal J. Comparison of Salivary pH, Buffering Capacity and Alkaline Phosphatase in Smokers and Healthy Non-Smokers: Retrospective cohort study. Sultan Qaboos Univ Med J. 2016 Aug;16(3):e317-21. doi: 10.18295/squmj.2016.16.03.009. Epub 2016 Aug 19.
• Gornowicz A, Tokajuk G, Bielawska A, Maciorkowska E, Jablonski R, Wojcicka A, Bielawski K. The assessment of sIgA, histatin-5, and lactoperoxidase levels in saliva of adolescents with dental caries. Med Sci Monit. 2014 Jun 29;20:1095-100. doi: 10.12659/MSM.890468.
• Acquier AB, Pita AK, Busch L, Sanchez GA. Comparison of salivary levels of mucin and amylase and their relation with clinical parameters obtained from patients with aggressive and chronic periodontal disease. J Appl Oral Sci. 2015 May-Jun;23(3):288-94. doi: 10.1590/1678-775720140458.
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• Hideaki W, Tatsuya H, Shogo M, Naruto Y, Hideaki T, Yoichi M, Yoshihiro O, Kazuo U, Hidenori T. Effect of 100 Hz electroacupuncture on salivary immunoglobulin A and the autonomic nervous system. Acupunct Med. 2015 Dec;33(6):451-6. doi: 10.1136/acupmed-2015-010784. Epub 2015 Oct 8.
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• Moynihan PJ, Kelly SA. Effect on caries of restricting sugars intake: systematic review to inform WHO guidelines. J Dent Res. 2014 Jan;93(1):8-18. doi: 10.1177/0022034513508954. Epub 2013 Dec 9.
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• Sanchez GA, Fernandez De Preliasco MV. Salivary pH changes during soft drinks consumption in children. Int J Paediatr Dent. 2003 Jul;13(4):251-7. doi: 10.1046/j.1365-263x.2003.00469.x.
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• Roos EH, Donly KJ. In vivo dental plaque pH variation with regular and diet soft drinks. Pediatr Dent. 2002 Jul-Aug;24(4):350-3.
• Llena-Puy C. The role of saliva in maintaining oral health and as an aid to diagnosis. Med Oral Patol Oral Cir Bucal. 2006 Aug;11(5):E449-55. English, Spanish.
• Saeed S, Al-Tinawi M. Evaluation of acidity and total sugar content of children's popular beverages and their effect on plaque pH. J Indian Soc Pedod Prev Dent. 2010 Jul-Sep;28(3):189-92. doi: 10.4103/0970-4388.73783.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): July 18, 2019

Study Registration Dates

• First Submitted: June 9, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 29, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: caries; saliva; pH; carbonated beverages; dental biofilm; artificial sweetener
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: HIM 2017-084 SSA 1411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD that underlie results in a publication
• IPD Sharing Time Frame: when summary data are published
• IPD Sharing Access Criteria: The data will be shared with researchers interested in data analysis, request to email: americaml@hotmail.com, review of the request by MSc., PhD. America Liliana Miranda Lora
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• 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