Clinical trial NCT05852145: Oral Changes With Caloric and no Caloric Sweeteners
Official title: Effect of the Consumption of Beverages Added With Stevia Rebaudiana on Oral pH and Dental Biofilm in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: pH
Microbiome
Dental Plaque
Keywords: artificial sweetener
stevioside
pH
caries
sucrose
dental biofilm
Lead sponsor: Hospital Infantil de Mexico Federico Gomez
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 52
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized Crossover Clinical Trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: A randomized crossover clinical trial will be conducted including 43 healthy adolescents participants (sample size with alpha=0.05 and beta=0.8 ). The intervention will consist of ingesting 250 mL of natural water (pH 7.1) in the first meeting, in subsequent meetings the natural water will be added with 1) 0.1 gr. of stevioside or 2) 25 gr. of sucrose. The washout period between interventions will be 1 week.

Participants will be informed of potential risks and those who sign the informed consent and complete the inclusion criteria will be randomized in a triple-blind manner.

The data will be collected in a special format including previous conditions, identification (age and sex) and possible adverse effects. If any possible adverse effect occurs, it will be notified to the research team to determine the changes.

* To determine the pH, saliva and dental biofilm samples will be obtained and analyzed using a HANNA potentiometer.
* To determine the bacterial proliferation, samples of dental biofilm will be obtained and the number of copies of Streptococcus mutans (S. mutans) and Streptococcus sobrinus (S. sobrinus) will be analyzed by polymerase reaction technique (PCR) of the 16S ribosomal gene fragment.
* To analyze dental biofilm microbiome, 11 of the 43 participants will be randomized for. Genetic sequencing will be performed and the amplicon Sequence Variants (ASVs) of S. mutans and S. sobrinus will be compared.

The data will be collected at a time indicated by a stopwatch and carried out by two verifiers.

The statistical analysis will be done according to the type of variable, these will be described with mean and standard deviation or frequencies and percentages. The pH will be compared by ANOVA analysis and adjusted by Bonferroni correction. Bacterial proliferation will be analyzed by Kruskal Wallis test. Statistical Package for the Social Sciences (SPSS) v. 22 program will be used considering p value ≤ 0.05. For the microbiome, the Amplicon Sequence Variants (ASVs) will be analyzed. Non-parametric multivariate analysis of variance and an analysis of similarities will be used. The p values will be calculated, identifying those that have differences in bacterial communities between the groups using the Genius (V3) software.

Eligibility criteria: 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

Primary outcomes:
measure: Mean salivary pH with natural water
timeFrame: 0 minutes
measure: Mean salivary pH with natural water
timeFrame: 5 minutes
measure: Mean salivary pH with natural water
timeFrame: 10 minutes
measure: Mean salivary pH with natural water
timeFrame: 15 minutes
measure: Mean salivary pH with natural water
timeFrame: 30 minutes
measure: Mean salivary pH with natural water
timeFrame: 45 minutes
measure: Mean salivary pH with natural water
timeFrame: 60 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 0 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 5 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 10 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 15 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 30 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 45 minutes
measure: Mean salivary pH with natural water added with 25 gr of sucrose
timeFrame: 60 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 0 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 5 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 10 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 15 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 30 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 45 minutes
measure: Mean salivary pH with natural water added with 0.1 gr of stevioside
timeFrame: 60 minutes
Secondary outcomes:
measure: Mean dental biofilm pH with natural water
timeFrame: 0 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 5 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 10 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 15 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 30 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 45 minutes
measure: Mean dental biofilm pH with natural water
timeFrame: 60 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 0 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 5 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 10 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 15 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 30 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 45 minutes
measure: Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose
timeFrame: 60 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 0 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 5 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 10 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 15 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 30 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 45 minutes
measure: Mean dental biofilm pH with natural water added with 0.1 gr stevioside
timeFrame: 60 minutes
Other outcomes:
measure: Dental biofilm proliferation with natural water
timeFrame: 0 minutes
measure: Dental biofilm proliferation with natural water
timeFrame: 120 minutes
measure: Dental biofilm proliferation with natural water added with 25 gr of sucrose
timeFrame: 0 minutes
measure: Dental biofilm proliferation with natural water added with 25 gr of sucrose
timeFrame: 120 minutes
measure: Dental biofilm proliferation with natural water added with 0.1 gr of stevioside
timeFrame: 0 minutes
measure: Dental biofilm proliferation with natural water added with 0.1 gr stevioside
timeFrame: 120 minutes
measure: Microbiome abundance with natural water
timeFrame: 0 minutes
measure: Microbiome abundance with natural water
timeFrame: 120 minutes
measure: Microbiome abundance with natural water added with 25 gr sucrose
timeFrame: 0 minutes
measure: Microbiome abundance with natural water added 25 gr of sucrose
timeFrame: 120 minutes
measure: Microbiome abundance with natural water added with 0.1 gr. of stevioside.
timeFrame: 0 minutes
measure: Microbiome abundance with natural water added with 0.1 gr. of stevioside.
timeFrame: 120 minutes
Locations:
Study officials:
affiliation: Children´s Hospital Federico Gómez. México
name: Carolina Barajas, MsC
role: PRINCIPAL_INVESTIGATOR
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