Oral Changes With Caloric and no Caloric Sweeteners

ConditionspH Microbiome Dental Plaque

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age12-18

SponsorHospital Infantil de Mexico Federico Gomez

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Orthodontic treatment

Topical application of fluoride during the last 3 months

Having a motor disability that interfered with tooth brushing

Xerostomia

Trial design

Design model

Crossover

Treatments tested in this trial

Stevioside
Drug
250 ml of natural water added with 0.1 gr. of stevioside should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
Sucrose
Drug
250 ml of natural water added with 25 gr of sucrose should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later
Natural water
Other intervention
250 ml of natural water should be drunk * Salivary pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Dental biofilm pH will be analyzed at 0,5,10,15,30,45 and 60 minutes later * Streptococcus mutans and Strepcotoccus sobrinus proliferation in dental biofilm ( PCR copies) will be analyzed at 0 and 120 minutes later * The relative abundance of Streptococcus mutans and Streptococcus sobrinus in dental biofilm will be analyzed using Amplicon Sequence Variant at 0 and 120 minutes later

Treatment groups

52 Participants

are divided into 3 treatment groups

Group A: Natural waterPlacebo comparator 3 interventions

Group B: SteviosideExperimental treatment 3 interventions

Group C: SucroseActive comparator 3 interventions