pHPhase 1pHSBNCT05437874
Carbonated Beverage Consumption in pH and Bacterial Proliferation
A Phase 1 study testing Natural Water in people with pH and Saliva, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
Trial summary
The objective of this research is to evaluate the oral modifications caused by different types of coke drinks (regular coke and diet coke). The salivary and the dental biofilm pH will be determined in the first minutes after their consumption. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- pH, Saliva, Dental Plaque
- What is being tested?
- Natural Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteMexico
- Study dates
- 18 Jan 2018to 18 Jul 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Habitual consumption of soft drinks
- DMFT (Decayed, Missing, and Filled Teeth) index of at least 3
- Agree to participate in the study and sign informed consent
- Parents sign informed consent
- Any nutritional condition
Who cannot join
- Undergoing orthodontic treatment
- Received a topical application of fluoride during the last 3 months
- Having a motor disability that interfered with tooth brushing
- Consuming drugs or being carriers of diseases that cause xerostomia
- Being under antibiotic therapy during the study period
- Having active periodontal infections.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Carbonated Beverage Consumption on Oral pH and Bacterial Proliferation in Adolescents: A Randomized Crossover Clinical Trial.
The objective of this research is to evaluate the oral modifications caused by different types of coke drinks (regular coke and diet coke). The salivary and the dental biofilm pH will be determined in the first minutes after their consumption. Additionally, the bacterial proliferation of dental biofilm will be evaluated.
Read the detailed description
Sugary soft drinks modify oral pH and favor bacterial proliferation and are associated with the development of caries. Information on the effects of consuming carbonated drinks without sucrose is limited.
In this crossover clinical trial, salivary pH and dental biofilm pH will be determined. These will be registered at 0, 5, 10, 15, 30, 45, and 60 min after the participants ingested 355 ml of natural water, soft drink with sucrose, soft drink with aspartame/acesulfame K or carbonated water on different days (1 week between each other). In addition, dental biofilm cultures will be conducted at 0 and 120 minutes after intake of each beverage to determine Streptococcus mutans biofilm formation.
The patients will be invited to participate and informed of the potential risks. Those who signed informed consent and have eligibility requirements will be randomized in a double-blind manner.
The data collection will be carried out in records forms, including verifying the patient's previous conditions, identification data (ID, age, gender,) and possible adverse events. If any adverse effect could exist, the research team will be notified for the implementation of possible changes.
A HANNA HI 221 potentiometer (HANNA Instruments Inc. Woonsocket-RI-USA, Romania) will be used to determine salivary pH and dental biofilm pH. The electrode will be calibrated using buffer solutions of pH 4.0 and 7.0 for correct records. The electrode will be washed with distilled water before and after each sample. The data will be collected by 2 verifiers, guaranteeing that the information obtained is the same as that indicated on the potentiometer; a stopwatch will indicate the exact time for obtaining the pH values.
Samples of dental biofilm will be taken, and Streptococcus mutans biofilm formation will be evaluated at 0 and 120 minutes after taking each beverage. The samples will be cultivated in suitable conditions, identified and compared with ATCC. The samples obtained will be analyzed in the same place of collection to avoid possible contamination.
Sample size with an alpha=0.05 and a beta=0.8 include 22, considering 20% losses.
Variables will be described with frequencies and percentages or medians and interquartile range (IQR) according to the variable type. Salivary pH and dental biofilm at different times will be compared using ANOVA analysis with adjustment for multiple comparisons using Bonferroni correction. Changes in the bacterial proliferation of the dental biofilm at 0 and 120 min will be compared using the Wilcoxon test and intergroup changes will be compared using the Kruskal-Wallis test. The statistical program SPSS v. 22 will be used and statistical significance will be considered with a p ≤ 0.05
- Conditions
- pH, Saliva, Dental Plaque
- Being tested
- Natural Water
- Keywords
- pH, caries, saliva, artificial sweetener, carbonated beverages, dental biofilm
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural WaterDrug
Also called Plain water
355 ml of regular coke, diet coke or mineral water should be drunk.
- Salivary pH will be determined 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 conducted at 0 and 120 minutes later
| Study group | Role | What they receive |
|---|---|---|
| Natural Water | Placebo comparator | 355 ml of water should be drunk.
* Salivary pH will be determined 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 conducted at 0 and 120 minutes later Receives: Drug: Natural Water |
| Carbonated water | Active comparator | 355 ml of carbonated water should be drunk
* Salivary pH will be determined 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 conducted at 0 and 120 minutes later Receives: Drug: Natural Water |
| Aspartame/acesulfame K | Experimental | 355 ml of drink of diet coke should be drunk.
* Salivary pH will be determined 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 conducted at 0 and 120 minutes later Receives: Drug: Natural Water |
| Saccharose | Experimental | 355 ml of drink of regular coke should be drunk
* Salivary pH will be determined 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 conducted at 0 and 120 minutes later Receives: Drug: Natural Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with carbonated water
logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean salivary pH with natual water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean salivary pH with natural water
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Secondary outcomes (28)
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with regular coke
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental pH biofilm with diet coke
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with diet coke
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean dental biofilm pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with diet carbonated water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental biofilm pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental pellicle pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with carbonated water
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 0 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 5 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 10 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 15 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 30 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 45 minutes
Mean dental biofilm pH with natural water
Logarithm of hydrogen ion concentration
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start18 Jan 2018
- Primary completion31 Jan 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for pHStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A Randomized Crossover Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil de Mexico Federico Gomez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guadalupe Barajas, Hospital Infantil de Mexico Federico Gomez
- Investigators
- Juan Garduño, MSc., PhD, Study director, Children´s Hospital of Mexico Federico Gómez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437874
- Sponsor's protocol ID
- HIM 2017-084 SSA 1411
- Acronym
- pHSB
- Status last verified
- Jun 2022
- First submitted
- 9 Jun 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Publications
Gonzalez-Aragon Pineda AE, Garcia Perez A, Garcia-Godoy F. Salivary parameters and oral health status amongst adolescents in Mexico. BMC Oral Health. 2020 Jul 6;20(1):190. doi: 10.1186/s12903-020-01182-8.
PubMed 32631313Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
PubMed 31590168Vieira AR, Modesto A, Marazita ML. Caries: review of human genetics research. Caries Res. 2014;48(5):491-506. doi: 10.1159/000358333. Epub 2014 May 21.
PubMed 24853115Krzysciak 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.
PubMed 25096795Mathur 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.
PubMed 25500618Koo 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.
PubMed 24045647Gonzalez-Aragon Pineda AE, Borges-Yanez SA, Irigoyen-Camacho ME, Lussi A. Relationship between erosive tooth wear and beverage consumption among a group of schoolchildren in Mexico City. Clin Oral Investig. 2019 Feb;23(2):715-723. doi: 10.1007/s00784-018-2489-8. Epub 2018 May 13.
PubMed 29756172Lemos JA, Palmer SR, Zeng L, Wen ZT, Kajfasz JK, Freires IA, Abranches J, Brady LJ. The Biology of Streptococcus mutans. Microbiol Spectr. 2019 Jan;7(1):10.1128/microbiolspec.gpp3-0051-2018. doi: 10.1128/microbiolspec.GPP3-0051-2018.
PubMed 30657107Bechir F, Pacurar M, Tohati A, Bataga SM. Comparative Study of Salivary pH, Buffer Capacity, and Flow in Patients with and without Gastroesophageal Reflux Disease. Int J Environ Res Public Health. 2021 Dec 25;19(1):201. doi: 10.3390/ijerph19010201.
PubMed 35010461Peng X, Han Q, Zhou X, Chen Y, Huang X, Guo X, Peng R, Wang H, Peng X, Cheng L. Effect of pH-sensitive nanoparticles on inhibiting oral biofilms. Drug Deliv. 2022 Dec;29(1):561-573. doi: 10.1080/10717544.2022.2037788.
PubMed 35156501Foglio-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.
PubMed 28165549Aiuchi H, Kitasako Y, Fukuda Y, Nakashima S, Burrow MF, Tagami J. Relationship between quantitative assessments of salivary buffering capacity and ion activity product for hydroxyapatite in relation to cariogenic potential. Aust Dent J. 2008 Jun;53(2):167-71. doi: 10.1111/j.1834-7819.2008.00027.x.
PubMed 18494973Ilie 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.
PubMed 24248036Humphrey 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.
PubMed 11208206Kaur 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.
PubMed 23263424
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Carbonated Beverage Consumption on Oral pH and Bacterial Proliferation in Adolescents: A Randomized Crossover Clinical Trial.
- ClinicalTrials.gov ID
- NCT05437874
- Acronym / sponsor ID
- pHSB / HIM 2017-084 SSA 1411
- Conditions
- pH, Saliva, Dental Plaque
- Keywords
- pH, caries, saliva, artificial sweetener, carbonated beverages, dental biofilm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hospital Infantil de Mexico Federico GomezUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research is to evaluate the oral modifications caused by different types of coke drinks (regular coke and diet coke). The salivary and the dental biofilm pH will be determined in the first minutes after their consumption. Additionally, the bacterial proliferation of dental biofilm will be evaluated.
Detailed description
Sugary soft drinks modify oral pH and favor bacterial proliferation and are associated with the development of caries. Information on the effects of consuming carbonated drinks without sucrose is limited.
In this crossover clinical trial, salivary pH and dental biofilm pH will be determined. These will be registered at 0, 5, 10, 15, 30, 45, and 60 min after the participants ingested 355 ml of natural water, soft drink with sucrose, soft drink with aspartame/acesulfame K or carbonated water on different days (1 week between each other). In addition, dental biofilm cultures will be conducted at 0 and 120 minutes after intake of each beverage to determine Streptococcus mutans biofilm formation.
The patients will be invited to participate and informed of the potential risks. Those who signed informed consent and have eligibility requirements will be randomized in a double-blind manner.
The data collection will be carried out in records forms, including verifying the patient's previous conditions, identification data (ID, age, gender,) and possible adverse events. If any adverse effect could exist, the research team will be notified for the implementation of possible changes.
A HANNA HI 221 potentiometer (HANNA Instruments Inc. Woonsocket-RI-USA, Romania) will be used to determine salivary pH and dental biofilm pH. The electrode will be calibrated using buffer solutions of pH 4.0 and 7.0 for correct records. The electrode will be washed with distilled water before and after each sample. The data will be collected by 2 verifiers, guaranteeing that the information obtained is the same as that indicated on the potentiometer; a stopwatch will indicate the exact time for obtaining the pH values.
Samples of dental biofilm will be taken, and Streptococcus mutans biofilm formation will be evaluated at 0 and 120 minutes after taking each beverage. The samples will be cultivated in suitable conditions, identified and compared with ATCC. The samples obtained will be analyzed in the same place of collection to avoid possible contamination.
Sample size with an alpha=0.05 and a beta=0.8 include 22, considering 20% losses.
Variables will be described with frequencies and percentages or medians and interquartile range (IQR) according to the variable type. Salivary pH and dental biofilm at different times will be compared using ANOVA analysis with adjustment for multiple comparisons using Bonferroni correction. Changes in the bacterial proliferation of the dental biofilm at 0 and 120 min will be compared using the Wilcoxon test and intergroup changes will be compared using the Kruskal-Wallis test. The statistical program SPSS v. 22 will be used and statistical significance will be considered with a p ≤ 0.05
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- A Randomized Crossover Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Natural Water | Placebo comparator | Drug: Natural Water355 ml of water should be drunk. * Salivary pH will be determined 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 conducted at 0 and 120 minutes later |
| Carbonated water | Active comparator | Drug: Natural Water355 ml of carbonated water should be drunk * Salivary pH will be determined 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 conducted at 0 and 120 minutes later |
| Aspartame/acesulfame K | Experimental | Drug: Natural Water355 ml of drink of diet coke should be drunk. * Salivary pH will be determined 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 conducted at 0 and 120 minutes later |
| Saccharose | Experimental | Drug: Natural Water355 ml of drink of regular coke should be drunk * Salivary pH will be determined 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 conducted at 0 and 120 minutes later |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Habitual consumption of soft drinks
- DMFT (Decayed, Missing, and Filled Teeth) index of at least 3
- Agree to participate in the study and sign informed consent
- Parents sign informed consent
- Any nutritional condition
Key exclusion criteria (6 listed)
- Undergoing orthodontic treatment
- Received a topical application of fluoride during the last 3 months
- Having a motor disability that interfered with tooth brushing
- Consuming drugs or being carriers of diseases that cause xerostomia
- Being under antibiotic therapy during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural WaterAlso: Plain water355 ml of regular coke, diet coke or mineral water should be drunk. * Salivary pH will be determined 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 conducted at 0 and 120 minutes later | Drug | Aspartame/acesulfame K, Carbonated water, Natural Water, Saccharose |
Primary outcome
Mean salivary pH with regular coke
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with regular coke
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with diet coke
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with carbonated water
Time frame: 60 minutes
logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 0 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 5 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 10 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 15 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 30 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natual water
Time frame: 45 minutes
Logarithm of hydrogen ion concentration
Mean salivary pH with natural water
Time frame: 60 minutes
Logarithm of hydrogen ion concentration
28 secondary outcomes
Mean dental biofilm pH with regular coke
Time frame: 0 minutes
Mean dental biofilm pH with regular coke
Time frame: 5 minutes
Mean dental biofilm pH with regular coke
Time frame: 10 minutes
Mean dental biofilm pH with regular coke
Time frame: 15 minutes
Mean dental biofilm pH with regular coke
Time frame: 30 minutes
Mean dental biofilm pH with regular coke
Time frame: 45 minutes
Mean dental biofilm pH with regular coke
Time frame: 60 minutes
Mean dental biofilm pH with diet coke
Time frame: 0 minutes
Mean dental biofilm pH with diet coke
Time frame: 5 minutes
Mean dental biofilm pH with diet coke
Time frame: 10 minutes
Mean dental pH biofilm with diet coke
Time frame: 15 minutes
Mean dental biofilm pH with diet coke
Time frame: 30 minutes
Mean dental biofilm pH with diet coke
Time frame: 45 minutes
Mean dental biofilm pH with diet coke
Time frame: 60 minutes
Mean dental biofilm pH with carbonated water
Time frame: 0 minutes
Mean dental biofilm pH with diet carbonated water
Time frame: 5 minutes
Mean dental biofilm pH with carbonated water
Time frame: 10 minutes
Mean dental biofilm pH with carbonated water
Time frame: 15 minutes
Mean dental pellicle pH with carbonated water
Time frame: 30 minutes
Mean dental biofilm pH with carbonated water
Time frame: 45 minutes
Mean dental biofilm pH with carbonated water
Time frame: 60 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Background: PubMed 32631313Gonzalez-Aragon Pineda AE, Garcia Perez A, Garcia-Godoy F. Salivary parameters and oral health status amongst adolescents in Mexico. BMC Oral Health. 2020 Jul 6;20(1):190. doi: 10.1186/s12903-020-01182-8.
- Background: PubMed 31590168Machiulskiene V, Campus G, Carvalho JC, Dige I, Ekstrand KR, Jablonski-Momeni A, Maltz M, Manton DJ, Martignon S, Martinez-Mier EA, Pitts NB, Schulte AG, Splieth CH, Tenuta LMA, Ferreira Zandona A, Nyvad B. Terminology of Dental Caries and Dental Caries Management: Consensus Report of a Workshop Organized by ORCA and Cariology Research Group of IADR. Caries Res. 2020;54(1):7-14. doi: 10.1159/000503309. Epub 2019 Oct 7.
- Background: PubMed 24853115Vieira AR, Modesto A, Marazita ML. Caries: review of human genetics research. Caries Res. 2014;48(5):491-506. doi: 10.1159/000358333. Epub 2014 May 21.
- Background: PubMed 25096795Krzysciak 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: PubMed 25500618Mathur 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: PubMed 24045647Koo 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: PubMed 29756172Gonzalez-Aragon Pineda AE, Borges-Yanez SA, Irigoyen-Camacho ME, Lussi A. Relationship between erosive tooth wear and beverage consumption among a group of schoolchildren in Mexico City. Clin Oral Investig. 2019 Feb;23(2):715-723. doi: 10.1007/s00784-018-2489-8. Epub 2018 May 13.
- Background: PubMed 30657107Lemos JA, Palmer SR, Zeng L, Wen ZT, Kajfasz JK, Freires IA, Abranches J, Brady LJ. The Biology of Streptococcus mutans. Microbiol Spectr. 2019 Jan;7(1):10.1128/microbiolspec.gpp3-0051-2018. doi: 10.1128/microbiolspec.GPP3-0051-2018.
- Background: PubMed 35010461Bechir F, Pacurar M, Tohati A, Bataga SM. Comparative Study of Salivary pH, Buffer Capacity, and Flow in Patients with and without Gastroesophageal Reflux Disease. Int J Environ Res Public Health. 2021 Dec 25;19(1):201. doi: 10.3390/ijerph19010201.
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- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Garduño, MSc., PhD study director
Children´s Hospital of Mexico Federico Gómez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Natural Water in people with pH and Saliva, run by Hospital Infantil de Mexico Federico Gomez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean salivary pH with regular coke (time frame: 0 minutes). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437874, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.