Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 12 to 18

Effects of water, stevioside, and sucrose drinks on mouth pH and dental plaque

Official title: Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents

Run by Hospital Infantil de Mexico Federico Gomez · NCT05852145 · Data updated 2026-11-12

This trial tests whether drinking plain water, stevioside‑sweetened, or sugar‑sweetened beverages changes mouth pH and dental plaque bacteria in Mexican adolescents who regularly drink soft drinks.

More Dental Plaque trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages12 Years to 18 Years
SexAll
Enrollment52 (estimated)
SponsorHospital Infantil de Mexico Federico Gomez
Academic / other
Locations1 site (Mexico City, Cuahutemoc)
StatusRecruiting
StartedAugust 1, 2025
Main results expectedDecember 2025
Study endsApril 2026
Registry record updatedOctober 9, 2025
Trial IDNCT05852145 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adolescents in Mexico City who regularly consume soft drinks, have a DMF index of at least 3, can obtain parental consent, and meet the study's health criteria.

Probably not a fit

Patients with orthodontic appliances, recent topical fluoride application, xerostomia, active periodontal infections, motor disabilities affecting tooth brushing, or recent/ongoing antibiotics may not benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, triple‑blind crossover trial will enroll 43 healthy Mexican adolescents who habitually consume soft drinks and have a DMF index ≥3. On three separate visits one week apart participants will drink 250 mL of natural water, water with 0.1 g stevioside, or water with 25 g sucrose in randomized order. Investigators will measure salivary and dental biofilm pH with a potentiometer, quantify Streptococcus mutans and Streptococcus sobrinus by PCR, and sequence the dental biofilm microbiome in a randomized subset of 11 participants. Data collection and adverse event monitoring will occur at Hospital Infantil de México Federico Gomez in Mexico City.

Why it matters

Potential benefit: If successful, the results could help identify which sweeteners are less likely to lower oral pH or promote caries‑associated bacteria, guiding safer beverage choices for teens.

How similar studies have gone: Previous research has consistently shown that sucrose lowers oral pH and promotes S. mutans growth while non‑caloric sweeteners like stevioside are generally less cariogenic, but few randomized crossover trials in adolescents directly compare these effects on the biofilm microbiome.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

  • Hospital Infantil de México Federico Gomez
    Mexico City, Cuahutemoc, Mexico
    Recruiting

Study contacts

  • Principal investigator: Carolina Barajas, MsC — Children´s Hospital Federico Gómez. México
  • Study coordinator: América L Miranda, PhD
  • Email: americaml@hotmail.com
  • Phone: 5552289917

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.