Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
52 participants
INTERVENTIONAL
2025-08-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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Participants will be informed of potential risks and those who sign the informed consent and complete the inclusion criteria will be randomized in a triple-blind manner.
The data will be collected in a special format including previous conditions, identification (age and sex) and possible adverse effects. If any possible adverse effect occurs, it will be notified to the research team to determine the changes.
* To determine the pH, saliva and dental biofilm samples will be obtained and analyzed using a HANNA potentiometer.
* To determine the bacterial proliferation, samples of dental biofilm will be obtained and the number of copies of Streptococcus mutans (S. mutans) and Streptococcus sobrinus (S. sobrinus) will be analyzed by polymerase reaction technique (PCR) of the 16S ribosomal gene fragment.
* To analyze dental biofilm microbiome, 11 of the 43 participants will be randomized for. Genetic sequencing will be performed and the amplicon Sequence Variants (ASVs) of S. mutans and S. sobrinus will be compared.
The data will be collected at a time indicated by a stopwatch and carried out by two verifiers.
The statistical analysis will be done according to the type of variable, these will be described with mean and standard deviation or frequencies and percentages. The pH will be compared by ANOVA analysis and adjusted by Bonferroni correction. Bacterial proliferation will be analyzed by Kruskal Wallis test. Statistical Package for the Social Sciences (SPSS) v. 22 program will be used considering p value ≤ 0.05. For the microbiome, the Amplicon Sequence Variants (ASVs) will be analyzed. Non-parametric multivariate analysis of variance and an analysis of similarities will be used. The p values will be calculated, identifying those that have differences in bacterial communities between the groups using the Genius (V3) software.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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Natural water
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
Stevioside
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
Sucrose
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
Natural water
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
Stevioside
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
Stevioside
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
Sucrose
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
Natural water
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
Sucrose
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
Stevioside
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
Sucrose
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
Natural water
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
Interventions
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Stevioside
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
Sucrose
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
Natural water
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
12 Years
18 Years
ALL
Yes
Sponsors
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Hospital Infantil de Mexico Federico Gomez
OTHER
Responsible Party
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Guadalupe Barajas
Principal Investigator
Principal Investigators
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Carolina Barajas, MsC
Role: PRINCIPAL_INVESTIGATOR
Children´s Hospital Federico Gómez. México
Locations
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Hospital Infantil de México Federico Gomez
Mexico City, Cuahutemoc, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Other Identifiers
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HIM 2022-049 FF
Identifier Type: -
Identifier Source: org_study_id
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