pHPhase 1/2NCT05852145
Oral Changes With Caloric and no Caloric Sweeteners
A Phase 1/2 study testing Stevioside, Sucrose and Natural water in people with pH and Microbiome, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- pH, Microbiome, Dental Plaque
- What is being tested?
- Stevioside, Sucrose and Natural water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2025to Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Infantil de México Federico Gomez
Mexico City, Cuahutemoc, 06720
Carolina Barajas, MsC, 55 52 28 9917 ext. 4600, barajascaro@hotmail.com
Carolina Barajas, MsC, 55 52 28 99 17 ext. 4600, barajascaro@hotmail.com
About this study
Official title: Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents
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.
Read the detailed description
A randomized crossover clinical trial will be conducted including 43 healthy adolescents participants (sample size with alpha=0.05 and beta=0.8 ). The intervention will consist of ingesting 250 mL of natural water (pH 7.1) in the first meeting, in subsequent meetings the natural water will be added with 1) 0.1 gr. of stevioside or 2) 25 gr. of sucrose. The washout period between interventions will be 1 week.
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
- pH, Microbiome, Dental Plaque
- Being tested
- Stevioside, Sucrose, Natural water
- Keywords
- artificial sweetener, stevioside, pH, caries, sucrose, dental biofilm
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteviosideDrug
Also called Non caloric sweetener
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
SucroseDrug
Also called Caloric sweetener
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 waterOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: Stevioside; Drug: Sucrose; Other: Natural water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with natural water added with 0.1 gr of stevioside
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Secondary outcomes (21)
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Aug 2025
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for pHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized Crossover Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guadalupe Barajas, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Carolina Barajas, MsC, Principal investigator, Children´s Hospital Federico Gómez. México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852145
- Sponsor's protocol ID
- HIM 2022-049 FF
- Status last verified
- Oct 2025
- First submitted
- 9 Apr 2023
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes: There is a plan to make Individual Participant Data (IPD) Sharing Statement.
Publications
Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35.
PubMed 25115106Edelstein 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.
PubMed 16934119Moradi 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.
PubMed 31970104Carvalho 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.
PubMed 29995065Skrivele 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.
PubMed 24037301Aamodt 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.
PubMed 26382724Irigoyen 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.
PubMed 22549683Garcia-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.
PubMed 25729867Krzysciak 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.
PubMed 25096795Mathur 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.
PubMed 25500618Humphrey 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.
PubMed 11208206Kaur 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.
PubMed 23263424He 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.
PubMed 25147055Koo 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.
PubMed 24045647Foglio-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.
PubMed 28165549
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents
- ClinicalTrials.gov ID
- NCT05852145
- Acronym / sponsor ID
- HIM 2022-049 FF
- Conditions
- pH, Microbiome, Dental Plaque
- Keywords
- artificial sweetener, stevioside, pH, caries, sucrose, dental biofilm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A randomized crossover clinical trial will be conducted including 43 healthy adolescents participants (sample size with alpha=0.05 and beta=0.8 ). The intervention will consist of ingesting 250 mL of natural water (pH 7.1) in the first meeting, in subsequent meetings the natural water will be added with 1) 0.1 gr. of stevioside or 2) 25 gr. of sucrose. The washout period between interventions will be 1 week.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A Randomized Crossover Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Natural water | Placebo comparator | Drug: Stevioside, Drug: Sucrose, Other: Natural water250 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 | Experimental | Drug: Stevioside, Drug: Sucrose, Other: Natural water250 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 |
| Sucrose | Active comparator | Drug: Stevioside, Drug: Sucrose, Other: Natural water250 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteviosideAlso: Non caloric sweetener250 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 | Drug | Natural water, Stevioside, Sucrose |
| SucroseAlso: Caloric sweetener250 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 | Drug | Natural water, Stevioside, Sucrose |
| Natural water250 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 | Natural water, Stevioside, Sucrose |
Primary outcome
Mean salivary pH with natural water
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 25 gr of sucrose
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water added with 0.1 gr of stevioside
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
21 secondary outcomes
Mean dental biofilm pH with natural water
Time frame: 0 minutes
Mean dental biofilm pH with natural water
Time frame: 5 minutes
Mean dental biofilm pH with natural water
Time frame: 10 minutes
Mean dental biofilm pH with natural water
Time frame: 15 minutes
Mean dental biofilm pH with natural water
Time frame: 30 minutes
Mean dental biofilm pH with natural water
Time frame: 45 minutes
Mean dental biofilm pH with natural water
Time frame: 60 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 0 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 5 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 10 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 15 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 30 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 45 minutes
Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
Time frame: 60 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 0 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 5 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 10 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 15 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 30 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 45 minutes
Mean dental biofilm pH with natural water added with 0.1 gr stevioside
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Background: PubMed 25115106Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35.
- Background: PubMed 16934119Edelstein 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.
- Background: PubMed 31970104Moradi 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.
- Background: PubMed 29995065Carvalho 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.
- Background: PubMed 24037301Skrivele 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.
- Background: PubMed 26382724Aamodt 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.
- Background: PubMed 22549683Irigoyen 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.
- Background: PubMed 25729867Garcia-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.
- Background: PubMed 25096795Krzysciak 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.
- Background: PubMed 25500618Mathur 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.
- Background: PubMed 11208206Humphrey 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.
- Background: PubMed 23263424Kaur 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.
- Individual participant dataSharing planned: Yes. Yes: There is a plan to make Individual Participant Data (IPD) Sharing Statement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carolina Barajas, MsC principal investigator
Children´s Hospital Federico Gómez. México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Stevioside, Sucrose and Natural water in people with pH and Microbiome, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact América L Miranda, PhD (5552289917 ext. 4304, americaml@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean salivary pH with natural water (time frame: 0 minutes). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05852145, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.