RecruitingPhase 1/2

Oral Changes With Caloric and no Caloric Sweeteners

Mexico52 participantsStarted 2025-08-01

Plain-language 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.

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean salivary pH with natural water

Timeframe: 0 minutes

Mean salivary pH with natural water

Timeframe: 5 minutes

Mean salivary pH with natural water

Timeframe: 10 minutes

Mean salivary pH with natural water

Timeframe: 15 minutes

Mean salivary pH with natural water

Timeframe: 30 minutes

Mean salivary pH with natural water

Timeframe: 45 minutes

Mean salivary pH with natural water

Timeframe: 60 minutes

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

Timeframe: 0 minutes

Trial details

NCT IDNCT05852145

SponsorHospital Infantil de Mexico Federico Gomez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

América L Miranda, PhD

5552289917 americaml@hotmail.com

View on ClinicalTrials.gov More pH trials

Plain-language summary

Who can participate

Age range

12 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean salivary pH with natural water

Timeframe: 0 minutes

Mean salivary pH with natural water

Timeframe: 5 minutes

Mean salivary pH with natural water

Timeframe: 10 minutes

Mean salivary pH with natural water

Timeframe: 15 minutes

Mean salivary pH with natural water

Timeframe: 30 minutes

Mean salivary pH with natural water

Timeframe: 45 minutes

Mean salivary pH with natural water

Timeframe: 60 minutes

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

Timeframe: 0 minutes