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Recruiting NCT05852145

Oral Changes With Caloric and no Caloric Sweeteners

Phase I / Phase II Interventional pH Microbiome Dental Plaque

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stevioside, Sucrose, Natural water.
Who it may be relevant to
Registry conditions: pH, Microbiome, Dental Plaque. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Stevioside
    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 Var
  • Drug Sucrose
    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
  • Other Natural 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

Primary outcome measures

  • Mean salivary pH with natural water [Time frame: 0 minutes]
  • Mean salivary pH with natural water [Time frame: 5 minutes]
  • Mean salivary pH with natural water [Time frame: 10 minutes]
  • Mean salivary pH with natural water [Time frame: 15 minutes]
  • Mean salivary pH with natural water [Time frame: 30 minutes]
  • Mean salivary pH with natural water [Time frame: 45 minutes]
  • Mean salivary pH with natural water [Time frame: 60 minutes]
  • Mean salivary pH with natural water added with 25 gr of sucrose [Time frame: 0 minutes]
  • Mean salivary pH with natural water added with 25 gr of sucrose [Time frame: 5 minutes]
  • Mean salivary pH with natural water added with 25 gr of sucrose [Time frame: 10 minutes]
Secondary outcome measures (12)
  • Mean dental biofilm pH with natural water [Time frame: 0 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 5 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 10 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 15 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 30 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 45 minutes]
  • Mean dental biofilm pH with natural water [Time frame: 60 minutes]
  • Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose [Time frame: 0 minutes]
  • Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose [Time frame: 5 minutes]
  • Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose [Time frame: 10 minutes]
  • Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose [Time frame: 15 minutes]
  • Mean Mean dental biofilm pH with natural water added with 25 gr of sucrose [Time frame: 30 minutes]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Hospital Infantil de México Federico Gomez — Mexico City

Publications

  • Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35. PMID 25115106
  • Edelstein BL. The dental caries pandemic and disparities problem. BMC Oral Health. 2006 Jun 15;6 Suppl 1(Suppl 1):S2. doi: 10.1186/1472-6831-6-S1-S2. PMID 16934119
  • Moradi G, Mohamadi Bolbanabad A, Moinafshar A, Adabi H, Sharafi M, Zareie B. Evaluation of Oral Health Status Based on the Decayed, Missing and Filled Teeth (DMFT) Index. Iran J Public Health. 2019 Nov;48(11):2050-2057. PMID 31970104
  • Carvalho RN, Letieri ADS, Vieira TI, Santos TMPD, Lopes RT, Neves AA, Pomarico L. Accuracy of visual and image-based ICDAS criteria compared with a micro-CT gold standard for caries detection on occlusal surfaces. Braz Oral Res. 2018 Jul 10;32:e60. doi: 10.1590/1807-3107bor-2018.vol32.0060. PMID 29995065
  • Skrivele S, Care R, Berzina S, Kneist S, de Moura-Sieber V, de Moura R, Borutta A, Maslak E, Tserekhava T, Shakovets N, Wagner M. Caries and its risk factors in young children in five different countries. Stomatologija. 2013;15(2):39-46. PMID 24037301
  • Aamodt K, Reyna-Blanco O, Sosa R, Hsieh R, De la Garza Ramos M, Garcia Martinez M, Orellana MF. Prevalence of caries and malocclusion in an indigenous population in Chiapas, Mexico. Int Dent J. 2015 Oct;65(5):249-55. doi: 10.1111/idj.12177. Epub 2015 Sep 18. PMID 26382724
  • Irigoyen ME, Mejia-Gonzalez A, Zepeda-Zepeda MA, Betancourt-Linares A, Lezana-Fernandez MA, Alvarez-Lucas CH. Dental caries in Mexican schoolchildren: a comparison of 1988-1989 and 1998-2001 surveys. Med Oral Patol Oral Cir Bucal. 2012 Sep 1;17(5):e825-32. doi: 10.4317/medoral.18008. PMID 22549683
  • Garcia-Cortes JO, Mejia-Cruz JA, Medina-Cerda E, Orozco-De la Torre G, Medina-Solis CC, Marquez-Rodriguez S, Navarrete-Hernandez Jde J, Islas-Granillo H. [Experience, prevalence, severity, treatment needs for dental caries and care index in Mexican adolescents and young adults]. Rev Invest Clin. 2014 Nov-Dec;66(6):505-11. Spanish. PMID 25729867

Identifiers

NCT: NCT05852145 · HIM 2022-049 FF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗