RecruitingPhase 1Phase 2NCT05852145

Oral Changes With Caloric and no Caloric Sweeteners

Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents


Sponsor

Hospital Infantil de Mexico Federico Gomez

Enrollment

52 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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

Interventions

DRUGStevioside

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

DRUGSucrose

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

OTHERNatural water

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


Locations(1)

Hospital Infantil de México Federico Gomez

Mexico City, Cuahutemoc, Mexico

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NCT05852145


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