Oral Changes With Caloric and no Caloric Sweeteners
In plain words A Phase 1 and 2 study of stevia in people 12 to 18, run by Hospital Infantil de Mexico Federico Gomez. It plans to enroll about 52 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people 12 to 18; healthy volunteers accepted. Conditions: pH; Microbiome; Dental Plaque.
- 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
1 more inclusion criterion and the exclusion criteria are on the listing.
What it tests, as registered
Stevioside; Sucrose; Natural water
Registered 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.
Where, as registered
No US site; Mexico (1).