Oral Changes With Caloric and no Caloric Sweeteners

Dental Plaque Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852145
• Other study ID #: HIM 2022-049 FF
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Hospital Infantil de Mexico Federico Gomez
• Contact: América L Miranda, PhD
• Phone: 5552289917
• Email: americaml[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this clinical trial is to compare the effect that the intake of beverages without sweetwners, 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.

Description:

A randomized crossover clinical trial will be conducted including 52 healthy adolescents participants (sample size with alpha=0.05 and beta=0.8 ). The intervention will consist of ingesting 355 mL of tea lemon flavor (pH 7.1) in the first meeting, in subsequent meetings the tea will be added with 1) 2.2 grams (gr.) of stevioside or 2) 7.5 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 double-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 in order to determine the changes.

• To determine the pH, saliva and dental biofilm samples will be obtained and analyzed using a HANNA potentiometer calibrated with buffer solutions.

• To determine bacterial proliferation, samples of dental biofilm will be obtained, cultivated in appropriate media and conditions, compared with the American Type Culture Collection (ATCC) catalog and the number of colony-forming units will be compared.

• To analyze the main components of the dental biofilm, genetic sequencing will be performed and the operative taxonomic units will be compared. (11 of the 52 participants will be randomized for microbiome analysis).

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 and statistical significance will be considered with p ≤ 0.05. For the microbiome, the principal component analysis (PCA) of each operational taxonomic unit (OTU) will be done. Non-parametric multivariate analysis of variance (Adonis) and an analysis of similarities (ANOSIM) will be used. The p values for Adonis and for ANOSIM will be calculated, identifying those that have differences in bacterial communities between the groups using the Genius (V3) software.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• Habitual consumption of soft drinks

• Decayed, Missing, and Filled Teeth (DMF) index of at least 3

• 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

Related Conditions & MeSH terms

• Dental Plaque
• Microbiome
• pH

Intervention

Drug:
• Stevioside
355 ml of tea lemon flavor added with 2.2 gr. of stevioside should be drunk Salivary pH will be collected at 0, 5, 10, 15, 30, 45 and 60 minutes later. Dental biofilm pH will be determined at 0, 5, 10, 15, 30, 45 and 60 minutes later. Streptococcus mutans dental biofilm formation ( Colony Forming Units) will be determined at 0 and 120 minutes later. Operative Taxonomic Units of dental biofilm will be analyzed at 0 and 120 minutes later.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Infantil de Mexico Federico Gomez

References & Publications (20)

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. — View Citation

Behjati S, Tarpey PS. What is next generation sequencing? Arch Dis Child Educ Pract Ed. 2013 Dec;98(6):236-8. doi: 10.1136/archdischild-2013-304340. Epub 2013 Aug 28. — View Citation

Brambilla E, Cagetti MG, Ionescu A, Campus G, Lingstrom P. An in vitro and in vivo comparison of the effect of Stevia rebaudiana extracts on different caries-related variables: a randomized controlled trial pilot study. Caries Res. 2014;48(1):19-23. doi: 10.1159/000351650. Epub 2013 Nov 6. — View Citation

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. — View Citation

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. — View Citation

Escobar E, Piedrahita M, Gregory RL. Growth and viability of Streptococcus mutans in sucrose with different concentrations of Stevia rebaudiana Bertoni. Clin Oral Investig. 2020 Sep;24(9):3237-3242. doi: 10.1007/s00784-020-03197-5. Epub 2020 Mar 18. — View Citation

Foglio-Bonda PL, Brilli K, Pattarino F, Foglio-Bonda A. Salivary flow rate and pH in patients with oral pathologies. Eur Rev Med Pharmacol Sci. 2017 Jan;21(2):369-374. — View Citation

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. — View Citation

He J, Li Y, Cao Y, Xue J, Zhou X. The oral microbiome diversity and its relation to human diseases. Folia Microbiol (Praha). 2015 Jan;60(1):69-80. doi: 10.1007/s12223-014-0342-2. Epub 2014 Aug 23. — View Citation

Humphrey SP, Williamson RT. A review of saliva: normal composition, flow, and function. J Prosthet Dent. 2001 Feb;85(2):162-9. doi: 10.1067/mpr.2001.113778. — View Citation

Ilie O, van Turnhout AG, van Loosdrecht MC, Picioreanu C. Numerical modelling of tooth enamel subsurface lesion formation induced by dental plaque. Caries Res. 2014;48(1):73-89. doi: 10.1159/000354123. Epub 2013 Nov 14. — View Citation

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. — View Citation

Kaur A, Kwatra KS, Kamboj P. Evaluation of non-microbial salivary caries activity parameters and salivary biochemical indicators in predicting dental caries. J Indian Soc Pedod Prev Dent. 2012 Jul-Sep;30(3):212-7. doi: 10.4103/0970-4388.105013. — View Citation

Koo H, Falsetta ML, Klein MI. The exopolysaccharide matrix: a virulence determinant of cariogenic biofilm. J Dent Res. 2013 Dec;92(12):1065-73. doi: 10.1177/0022034513504218. Epub 2013 Sep 17. — View Citation

Krzysciak W, Pluskwa KK, Piatkowski J, Krzysciak P, Jurczak A, Koscielniak D, Skalniak A. The usefulness of biotyping in the determination of selected pathogenicity determinants in Streptococcus mutans. BMC Microbiol. 2014 Aug 5;14:194. doi: 10.1186/1471-2180-14-194. — View Citation

Mathur MR, Tsakos G, Millett C, Arora M, Watt R. Socioeconomic inequalities in dental caries and their determinants in adolescents in New Delhi, India. BMJ Open. 2014 Dec 12;4(12):e006391. doi: 10.1136/bmjopen-2014-006391. — View Citation

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. — View Citation

Pandey P, Reddy NV, Rao VA, Saxena A, Chaudhary CP. Estimation of salivary flow rate, pH, buffer capacity, calcium, total protein content and total antioxidant capacity in relation to dental caries severity, age and gender. Contemp Clin Dent. 2015 Mar;6(Suppl 1):S65-71. doi: 10.4103/0976-237X.152943. — View Citation

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. — View Citation

Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor	Number of viable colonies on a semisolid agar culture medium that are visible and separable	0 minutes
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor	Number of viable colonies on a semisolid agar culture medium that are visible and separable	120 minutes
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor added with 2.2 gr. stevioside	Number of viable colonies on a semisolid agar culture medium that are visible and separable	0 minutes
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor added with 2.2 gr. stevioside	Number of viable colonies on a semisolid agar culture medium that are visible and separable	120 minutes
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor added with 7.5 gr sucrose	Number of viable colonies on a semisolid agar culture medium that are visible and separable	0 minutes
Other	Mean Colony Forming Units Streptococcus mutans dental biofilm with tea lemon flavor added with 7.5 gr sucrose	Number of viable colonies on a semisolid agar culture medium that are visible and separable	120 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor	Operative Taxonomic Units	0 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor	Operative Taxonomic Units	120 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor added with 2.2 gr. of stevioside.	Operative Taxonomic Units	0 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor added with 2.2 gr. of stevioside.	Operative Taxonomic Units	120 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor added with 7.5 gr. of sucrose	Operative Taxonomic Units	0 minutes
Other	Principal component analysis of dental biofilm with tea lemon flavor added with 7.5 gr. of sucrose	Operative Taxonomic Units	120 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	0 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	5 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	10 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	15 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	30 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	45 minutes
Primary	Mean salivary pH with tea lemon flavor	Logarithm of hydrogen ion concentration	60 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	0 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	5 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	10 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	15 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	30 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	45 minutes
Primary	Mean salivary pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	60 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	0 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	5 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	10 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	15 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	30 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	45 minutes
Primary	Mean salivary pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	60 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	0 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	5 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	10 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	15 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	30 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	45 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor	Logarithm of hydrogen ion concentration	60 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	0 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	5 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	10 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	15 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	30 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	45 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 2.2 gr. of stevioside	Logarithm of hydrogen ion concentration	60 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	0 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	5 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	10 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	15 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	30 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	45 minutes
Secondary	Mean dental biofilm pH with tea lemon flavor added with 7.5 gr. sucrose	Logarithm of hydrogen ion concentration	60 minutes