drugset / Trial / NCT05852145
Oral Changes With Caloric and no Caloric Sweeteners
RandomizedCrossoverTriple-blindTreatment
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.
Timeline
- Start
- 2025-08-01
- Primary completion
- 2025-12
- Completion
- 2026-04
Publications
- Background Struzycka I. The oral microbiome in dental caries. Pol J Microbiol. 2014;63(2):127-35.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Stevioside | Unknown | 0.1 g | Oral |
| Subject | Sucrose | Small molecule | 25 g | Oral |