Effects of water, stevioside, and sucrose drinks on mouth pH and dental plaque
Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents
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.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Hospital Infantil de Mexico Federico Gomez Academic / other |
| Locations | 1 site (Mexico City, Cuahutemoc) |
| Trial ID | NCT05852145 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mexico City, Cuahutemoc
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.