Carbonated Beverage Consumption in pH and Bacterial Proliferation

NCT05437874 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HIM 2017-084 SSA 1411
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

pH; Saliva; Dental Plaque

Keywords

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

Outcome Measures

Primary Outcomes (28)

• 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 Outcomes (28)

• Mean dental biofilm pH with regular coke

  0 minutes

• Mean dental biofilm pH with regular coke

  5 minutes

• Mean dental biofilm pH with regular coke

  10 minutes

• Mean dental biofilm pH with regular coke

  15 minutes

• Mean dental biofilm pH with regular coke

  30 minutes

Other Outcomes (8)

• Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke

  0 minutes

• Mean Colony Forming Units Streptococcus mutans dental biofilm with regular coke

  120 minutes

• Mean Colony Forming Units Streptococcus mutans dental biofilm with diet coke

  0 minutes

Study Arms (4)

Natural Water

PLACEBO COMPARATOR

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

Carbonated water

ACTIVE COMPARATOR

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

Aspartame/acesulfame K

EXPERIMENTAL

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

Saccharose

EXPERIMENTAL

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

Interventions

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

Also known as: Plain water

Aspartame/acesulfame K; Carbonated water; Natural Water; Saccharose

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Children´s Hospital of Mexico Federico Gómez

Mexico City, 06720, Mexico

Location

Related Publications (30)

• 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.

  PMID: 32631313 BACKGROUND

• 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.

  PMID: 31590168 BACKGROUND

• 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.

  PMID: 24853115 BACKGROUND

• 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.

  PMID: 25096795 BACKGROUND

• 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.

  PMID: 25500618 BACKGROUND

• 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.

  PMID: 24045647 BACKGROUND

• 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.

  PMID: 29756172 BACKGROUND

• 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.

  PMID: 30657107 BACKGROUND

• 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.

  PMID: 35010461 BACKGROUND

• Peng X, Han Q, Zhou X, Chen Y, Huang X, Guo X, Peng R, Wang H, Peng X, Cheng L. Effect of pH-sensitive nanoparticles on inhibiting oral biofilms. Drug Deliv. 2022 Dec;29(1):561-573. doi: 10.1080/10717544.2022.2037788.

  PMID: 35156501 BACKGROUND

• Foglio-Bonda PL, Brilli K, Pattarino F, Foglio-Bonda A. Salivary flow rate and pH in patients with oral pathologies. Eur Rev Med Pharmacol Sci. 2017 Jan;21(2):369-374.

  PMID: 28165549 BACKGROUND

• Aiuchi H, Kitasako Y, Fukuda Y, Nakashima S, Burrow MF, Tagami J. Relationship between quantitative assessments of salivary buffering capacity and ion activity product for hydroxyapatite in relation to cariogenic potential. Aust Dent J. 2008 Jun;53(2):167-71. doi: 10.1111/j.1834-7819.2008.00027.x.

  PMID: 18494973 BACKGROUND

• 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.

  PMID: 24248036 BACKGROUND

• 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.

  PMID: 11208206 BACKGROUND

• 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.

  PMID: 23263424 BACKGROUND

• 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.

  PMID: 27606111 BACKGROUND

• 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.

  PMID: 24974109 BACKGROUND

• 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.

  PMID: 26221923 BACKGROUND

• Gabryel-Porowska H, Gornowicz A, Bielawska A, Wojcicka A, Maciorkowska E, Grabowska SZ, Bielawski K. Mucin levels in saliva of adolescents with dental caries. Med Sci Monit. 2014 Jan 18;20:72-7. doi: 10.12659/MSM.889718.

  PMID: 24441930 BACKGROUND

• 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.

  PMID: 26449884 BACKGROUND

• Moradi G, Mohamadi Bolbanabad A, Moinafshar A, Adabi H, Sharafi M, Zareie B. Evaluation of Oral Health Status Based on the Decayed, Missing and Filled Teeth (DMFT) Index. Iran J Public Health. 2019 Nov;48(11):2050-2057.

  PMID: 31970104 BACKGROUND

• 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.

  PMID: 24323509 RESULT

• Olivier B, Serge AH, Catherine A, Jacques B, Murielle B, Marie-Chantal CL, Sybil C, Jean-Philippe G, Sabine H, Esther K, Perrine N, Fabienne R, Gerard S, Irene M. Review of the nutritional benefits and risks related to intense sweeteners. Arch Public Health. 2015 Oct 1;73:41. doi: 10.1186/s13690-015-0092-x. eCollection 2015.

  PMID: 26430511 RESULT

• Brambilla E, Cagetti MG, Ionescu A, Campus G, Lingstrom P. An in vitro and in vivo comparison of the effect of Stevia rebaudiana extracts on different caries-related variables: a randomized controlled trial pilot study. Caries Res. 2014;48(1):19-23. doi: 10.1159/000351650. Epub 2013 Nov 6.

  PMID: 24216624 RESULT

• Jawale BA, Bendgude V, Mahuli AV, Dave B, Kulkarni H, Mittal S. Dental plaque pH variation with regular soft drink, diet soft drink and high energy drink: an in vivo study. J Contemp Dent Pract. 2012 Mar 1;13(2):201-4. doi: 10.5005/jp-journals-10024-1121.

  PMID: 22665748 RESULT

• 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.

  PMID: 12834385 RESULT

• Uma E, Theng KS, Yi LLH, Yun LH, Varghese E, Soe HHK. Comparison of Salivary pH Changes after Consumption of Two Sweetened Malaysian Local Drinks among Individuals with Low Caries Experience: A Pilot Study. Malays J Med Sci. 2018 Jul;25(4):100-111. doi: 10.21315/mjms2018.25.4.10. Epub 2018 Aug 30.

  PMID: 30914852 RESULT

• 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.

  PMID: 12212881 RESULT

• 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.

  PMID: 16878065 RESULT

• 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.

  PMID: 21157052 RESULT

MeSH Terms

Conditions

Dental Plaque

Interventions

Natural Childbirth

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Parturition; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Juan Garduño, MSc., PhD

  Children´s Hospital of Mexico Federico Gómez

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: colors were designated for each drink
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomized Crossover Clinical Trial

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 29, 2022
• Study Start: January 18, 2018
• Primary Completion: January 31, 2019
• Study Completion: July 18, 2019
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: when summary data are published
• 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

Locations

ME (1)