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 range12 Years – 18 Years

SexALL

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

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

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

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 range12 Years – 18 Years

SexALL

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

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