Oral Changes With Caloric and no Caloric Sweeteners

NCT05852145 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HIM 2022-049 FF
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical trial is to compare the effect that the intake of beverages without sweeteners, added with non-caloric sweeteners (stevioside) and caloric sweeteners (sucrose) on oral pH and dental biofilm microbiome in Mexican adolescents. Participants will drink on different occasions a beverage without sweetener, a beverage added with stevioside or a beverage added with sucrose. The researchers will compare the changes that each one causes in salivary pH, dental biofilm pH, dental biofilm bacterial proliferation and dental biofilm microbiome.

Conditions

pH; Microbiome; Dental Plaque

Keywords

artificial sweetener; stevioside; pH; caries; sucrose; dental biofilm

Outcome Measures

Primary Outcomes (21)

• 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 natural water

  Logarithm of hydrogen ion concentration

  45 minutes

• Mean salivary pH with natural water

  Logarithm of hydrogen ion concentration

  60 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  0 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  5 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  10 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  15 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  30 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  45 minutes

• Mean salivary pH with natural water added with 25 gr of sucrose

  Logarithm of hydrogen ion concentration

  60 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  0 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  5 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  10 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  15 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  30 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  45 minutes

• Mean salivary pH with natural water added with 0.1 gr of stevioside

  Logarithm of hydrogen ion concentration

  60 minutes

Secondary Outcomes (21)

• Mean dental biofilm pH with natural water

  0 minutes

• Mean dental biofilm pH with natural water

  5 minutes

• Mean dental biofilm pH with natural water

  10 minutes

• Mean dental biofilm pH with natural water

  15 minutes

• Mean dental biofilm pH with natural water

  30 minutes

Other Outcomes (12)

• Dental biofilm proliferation with natural water

  0 minutes

• Dental biofilm proliferation with natural water

  120 minutes

• Dental biofilm proliferation with natural water added with 25 gr of sucrose

  0 minutes

Study Arms (3)

Natural water

PLACEBO COMPARATOR

250 ml of natural water should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Drug: Stevioside; Drug: Sucrose; Other: Natural water

Stevioside

EXPERIMENTAL

250 ml of natural water added with 0.1 grams of stevioside should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Drug: Stevioside; Drug: Sucrose; Other: Natural water

Sucrose

ACTIVE COMPARATOR

250 ml of natural water added with 25 of sucrose grams with should be drunk. * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Streptoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Drug: Stevioside; Drug: Sucrose; Other: Natural water

Interventions

Stevioside DRUG

250 ml of natural water added with 0.1 gr. of stevioside should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Also known as: Non caloric sweetener

Natural water; Stevioside; Sucrose

Sucrose DRUG

250 ml of natural water added with 25 gr of sucrose should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Also known as: Caloric sweetener

Natural water; Stevioside; Sucrose

Natural water OTHER

250 ml of natural water should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Natural water; Stevioside; Sucrose

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
• Decayed, Missing, and Filled Teeth (DMF) index of at least 3 (considering as caries those lesions that are visible without the tooth needing to be dry)
• Agree to participate in the study and sign informed consent
• Parents sign informed consent
• Any nutritional condition

You may not qualify if:

• Orthodontic treatment
• Topical application of fluoride during the last 3 months
• Having a motor disability that interfered with tooth brushing
• Xerostomia
• Antibiotic therapy during the study period
• Periodontal infections

Sponsors & Collaborators

• Hospital Infantil de Mexico Federico Gomez: lead

Study Sites (1)

Hospital Infantil de México Federico Gomez

Mexico City, Cuahutemoc, 06720, Mexico

RECRUITING

Related Publications (20)

• Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35.

  PMID: 25115106 BACKGROUND

• Edelstein BL. The dental caries pandemic and disparities problem. BMC Oral Health. 2006 Jun 15;6 Suppl 1(Suppl 1):S2. doi: 10.1186/1472-6831-6-S1-S2.

  PMID: 16934119 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

• Carvalho RN, Letieri ADS, Vieira TI, Santos TMPD, Lopes RT, Neves AA, Pomarico L. Accuracy of visual and image-based ICDAS criteria compared with a micro-CT gold standard for caries detection on occlusal surfaces. Braz Oral Res. 2018 Jul 10;32:e60. doi: 10.1590/1807-3107bor-2018.vol32.0060.

  PMID: 29995065 BACKGROUND

• Skrivele S, Care R, Berzina S, Kneist S, de Moura-Sieber V, de Moura R, Borutta A, Maslak E, Tserekhava T, Shakovets N, Wagner M. Caries and its risk factors in young children in five different countries. Stomatologija. 2013;15(2):39-46.

  PMID: 24037301 BACKGROUND

• Aamodt K, Reyna-Blanco O, Sosa R, Hsieh R, De la Garza Ramos M, Garcia Martinez M, Orellana MF. Prevalence of caries and malocclusion in an indigenous population in Chiapas, Mexico. Int Dent J. 2015 Oct;65(5):249-55. doi: 10.1111/idj.12177. Epub 2015 Sep 18.

  PMID: 26382724 BACKGROUND

• Irigoyen ME, Mejia-Gonzalez A, Zepeda-Zepeda MA, Betancourt-Linares A, Lezana-Fernandez MA, Alvarez-Lucas CH. Dental caries in Mexican schoolchildren: a comparison of 1988-1989 and 1998-2001 surveys. Med Oral Patol Oral Cir Bucal. 2012 Sep 1;17(5):e825-32. doi: 10.4317/medoral.18008.

  PMID: 22549683 BACKGROUND

• Garcia-Cortes JO, Mejia-Cruz JA, Medina-Cerda E, Orozco-De la Torre G, Medina-Solis CC, Marquez-Rodriguez S, Navarrete-Hernandez Jde J, Islas-Granillo H. [Experience, prevalence, severity, treatment needs for dental caries and care index in Mexican adolescents and young adults]. Rev Invest Clin. 2014 Nov-Dec;66(6):505-11. Spanish.

  PMID: 25729867 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

• 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

• He J, Li Y, Cao Y, Xue J, Zhou X. The oral microbiome diversity and its relation to human diseases. Folia Microbiol (Praha). 2015 Jan;60(1):69-80. doi: 10.1007/s12223-014-0342-2. Epub 2014 Aug 23.

  PMID: 25147055 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

• 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

• 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

• Pandey P, Reddy NV, Rao VA, Saxena A, Chaudhary CP. Estimation of salivary flow rate, pH, buffer capacity, calcium, total protein content and total antioxidant capacity in relation to dental caries severity, age and gender. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S65-71. doi: 10.4103/0976-237X.152943.

  PMID: 25821379 BACKGROUND

• Escobar E, Piedrahita M, Gregory RL. Growth and viability of Streptococcus mutans in sucrose with different concentrations of Stevia rebaudiana Bertoni. Clin Oral Investig. 2020 Sep;24(9):3237-3242. doi: 10.1007/s00784-020-03197-5. Epub 2020 Mar 18.

  PMID: 32189073 BACKGROUND

• 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 BACKGROUND

• Behjati S, Tarpey PS. What is next generation sequencing? Arch Dis Child Educ Pract Ed. 2013 Dec;98(6):236-8. doi: 10.1136/archdischild-2013-304340. Epub 2013 Aug 28.

  PMID: 23986538 BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Interventions

stevioside; Sucrose; Natural Childbirth

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Parturition; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Carolina Barajas, MsC

  Children´s Hospital Federico Gómez. México

  PRINCIPAL INVESTIGATOR

Central Study Contacts

América L Miranda, PhD

CONTACT

5552289917; americaml@hotmail.com

Guadalupe C Barajas, MsC

CONTACT

5536596998; barajascaro@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: colors will be assigned for each sweetener
• Purpose: TREATMENT
• 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: April 9, 2023
• First Posted: May 10, 2023
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: At the time of manuscript publication
• Access Criteria: Asking for email

Locations

ME (1)