HealthyNCT06370091
Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults
A study testing Gum of Xylitol, Gum of sugar free and Gum of sugar in people with Healthy, run by Universidad Católica de Cuenca at 1 site in Ecuador.
Trial summary
This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gum of Xylitol, Gum of sugar free and Gum of sugar
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEcuador
- Study dates
- 12 Dec 2023to 28 Feb 2025
- Phase
- Interventional
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet at least 20 teeth.
- Providing written informed consent. and being willing to comply with the study procedures.
- Being willing to comply with the study procedures
Who cannot join
- Individuals with systemic, infectious, or inflammatory diseases
- Individuals who are taking medications, antibiotics, or fluoride in the last month.
- Regular consumers of products and mouthwashes containing xylitol or sorbitol.
- Individuals with abnormal salivary flow (<1 ml/min).
- Pregnant women or those on contraceptive pill treatment.
- Individuals with abnormal dietary habits.
- Subjects with periodontal disease or presence of dental caries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults: Randomized Controlled Clinical Trial
This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults.
Read the detailed description
Chewing gum stimulates salivary flow, neutralizes and raises pH, and serves as a medium for administering therapeutic agents. However, global increases in sugar consumption have led to the development of chewing gums containing sugar substitutes, including polyols or non-fermentable sugars, of which the most commonly used are nutritive sweeteners such as sorbitol and xylitol.The use of polyol-containing chewing gums could play a role in preventing dental caries compared to not using gum or using sugared gum, most likely due to increased salivary flow and pH, improving enamel lesion remineralization; however, xylitol has anticariogenic properties influencing the reduction of dental plaque.
The study will conduct as a prospective randomized controlled trial. The population will consist of all enrolled students (1275 students) in the Dentistry program at the Catholic University aged 18 to 25 who voluntarily meet the inclusion criteria. The sample size will be 21 participants in each group, but it will be adjusted for a 15% loss of information or study dropout, thus requiring 25 participants in each group. Participants who meet the selection criteria will be probabilistically assigned using simple random sampling through a lottery system to four groups: the first group (G1) will consume xylitol chewing gum, the second group (G2) will consume sugar-free gum, the third group (G3) will consume sugared gum, and the fourth group (G4), the control, will chew paraffin.
Saliva samples will be taken between 8 to 10 am, taking into account that subjects should not have ingested food, smoked, or brushed their teeth at least 1 hour prior to sample collection. They will be asked to rinse their mouth with pure water to remove any food residue. Subsequently, they will be seated in a chair in an upright position with the head slightly tilted forward and eyes open, and the basal saliva sample will be taken as indicated by the established protocol of the collection method for unstimulated saliva by Tomas Seif. Before starting the test, they will be asked to swallow saliva, keep their mouth slightly open, and allow saliva to drain into the tube. The test lasts for five minutes and the salivary pH will be evaluated and recorded, labeled as T1. For stimulated saliva, the protocol dictated by the Faculty of Dentistry at the University of Southern California will be used. Through the drainage method, stimulated saliva will be collected in another pre-weighed test tube at three more time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after starting chewing gum consumption. The Measurement of saliva pH level will be evaluated immediately using a pH meter (BT-675 meter, Boeco-Germany), while the salivary flow will be evaluated by the difference in weight of the basal pH with the final pH.
Data will be entered into an Excel spreadsheet and data analysis will be performed. The analysis will be conducted using SPSS v.25, with descriptive data analysis. Chi-square test will be used for demographic data, Levene's test will determine data homogeneity, and ANOVA will determine differences in means, followed by Tukey's post-hoc comparison to find significant differences between group means, with a significance level of p<0.05.
The expected results, that the mean salivary pH and flow will differ among the different chewing gums
- Conditions
- Healthy
- Being tested
- Gum of Xylitol, Gum of sugar free, Gum of sugar, Paraffin wax
- Keywords
- Chewing gum, Xylitol, Sugars, Salival, Dental Plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum of XylitolOther
After each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow
Gum of sugar freeOther
After each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow
Gum of sugarOther
After each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow
Paraffin waxOther
After each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow
| Study group | Role | What they receive |
|---|---|---|
| G1: Gum of Xylitol | Experimental | They will consume chewing gum with xylitol (Xylichew), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption Receives: Other: Gum of Xylitol |
| G2: Gum of sugar free | Active comparator | They will consume sugar-free chewing gum (Trident), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption Receives: Other: Gum of sugar free |
| G3: Gum of sugar | Active comparator | Formed by participants who will chew sugared gum (Agogó), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption Receives: Other: Gum of sugar |
| G4: paraffin wax | Placebo comparator | The control group will chew paraffin wax (Dentek), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing paraffin wax Receives: Other: Paraffin wax |
What is being measured
The primary outcome is the main question the study is designed to answer.
G1: Gum of xilytol
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
Measured: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
G2: Gum of sugar free
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
Measured: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
G3: Gum of sugar
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
Measured: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
G4: Parafinn wax
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
Measured: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start12 Dec 2023
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be an experimental study through a double-blind parallel randomized controlled trial. All saliva samples will be collected using the spitting method. Each participant will provide a basal saliva sample for 5 minutes. Participants must meet the following inclusion criteria: having at least 20 teeth, providing written informed consent, and being willing to comply with the study procedures. The exclusion criteria will include individuals with systemic, infectious, or inflammatory diseases or those taking medications, antibiotics, or fluoride in the last month; regular consumers of products and mouthwashes containing xylitol or sorbitol, with abnormal salivary flow (\<1 ml/min), pregnant women or those on contraceptive pill treatment, or with abnormal dietary habits; subjects with periodontal disease or presence of dental caries
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Cuenca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Lima, Universidad Católica de Cuenca
- Investigators
- Miriam Lima, PhD, Principal investigator, Universidad Católica de Cuenca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370091
- Sponsor's protocol ID
- PICVII19-41
- Status last verified
- Nov 2024
- First submitted
- 6 Apr 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) underlying the results of the publication will be shared.
Publications
Giacaman RA. Sugars and beyond. The role of sugars and the other nutrients and their potential impact on caries. Oral Dis. 2018 Oct;24(7):1185-1197. doi: 10.1111/odi.12778. Epub 2017 Oct 6.
PubMed 28898520Vantipalli UK, Avula SSJ, Enuganti S, Bandi S, Kakarla P, Kuravadi RV. Effect of three commercially available chewing gums on salivary flow rate and pH in caries-active and caries-free children: An in vivo study. J Indian Soc Pedod Prev Dent. 2017 Jul-Sep;35(3):254-259. doi: 10.4103/JISPPD.JISPPD_256_16.
PubMed 28762353Shinde MR, Winnier J. Comparative evaluation of Stevia and Xylitol chewing gum on salivary Streptococcus mutans count - A pilot study. J Clin Exp Dent. 2020 Jun 1;12(6):e568-e573. doi: 10.4317/jced.55720. eCollection 2020 Jun.
PubMed 32665816Rafeek R, Carrington CVF, Gomez A, Harkins D, Torralba M, Kuelbs C, Addae J, Moustafa A, Nelson KE. Xylitol and sorbitol effects on the microbiome of saliva and plaque. J Oral Microbiol. 2018 Oct 23;11(1):1536181. doi: 10.1080/20002297.2018.1536181. eCollection 2019.
PubMed 30598728Zimmer S, Spyra A, Kreimendahl F, Blaich C, Rychlik R. Elevating the use of sugar-free chewing gum in Germany: cost saving and caries prevention. Acta Odontol Scand. 2018 Aug;76(6):407-414. doi: 10.1080/00016357.2018.1487994. Epub 2018 Jun 27.
PubMed 29947271Hashiba T, Takeuchi K, Shimazaki Y, Takeshita T, Yamashita Y. Chewing xylitol gum improves self-rated and objective indicators of oral health status under conditions interrupting regular oral hygiene. Tohoku J Exp Med. 2015 Jan;235(1):39-46. doi: 10.1620/tjem.235.39.
PubMed 25744362Keukenmeester RS, Slot DE, Putt MS, Van der Weijden GA. The effect of medicated, sugar-free chewing gum on plaque and clinical parameters of gingival inflammation: a systematic review. Int J Dent Hyg. 2014 Feb;12(1):2-16. doi: 10.1111/idh.12026. Epub 2013 Jun 24.
PubMed 23790138Tapiainen T, Renko M, Kontiokari T, Uhari M. Xylitol concentrations in the saliva of children after chewing xylitol gum or consuming a xylitol mixture. Eur J Clin Microbiol Infect Dis. 2002 Jan;21(1):53-5. doi: 10.1007/s10096-001-0654-4.
PubMed 11913502Navazesh M, Kumar SK; University of Southern California School of Dentistry. Measuring salivary flow: challenges and opportunities. J Am Dent Assoc. 2008 May;139 Suppl:35S-40S. doi: 10.14219/jada.archive.2008.0353.
PubMed 18460678
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06370091
- Acronym / sponsor ID
- PICVII19-41
- Conditions
- Healthy
- Keywords
- Chewing gum, Xylitol, Sugars, Salival, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidad Católica de CuencaUniversity, hospital or other
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 17 Apr 2024 (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.
This study was planned to evaluate the effects of xylitol-based chewing gums, sugar-free and sugared, on salivary flow and pH in young adults.
Detailed description
Chewing gum stimulates salivary flow, neutralizes and raises pH, and serves as a medium for administering therapeutic agents. However, global increases in sugar consumption have led to the development of chewing gums containing sugar substitutes, including polyols or non-fermentable sugars, of which the most commonly used are nutritive sweeteners such as sorbitol and xylitol.The use of polyol-containing chewing gums could play a role in preventing dental caries compared to not using gum or using sugared gum, most likely due to increased salivary flow and pH, improving enamel lesion remineralization; however, xylitol has anticariogenic properties influencing the reduction of dental plaque.
The study will conduct as a prospective randomized controlled trial. The population will consist of all enrolled students (1275 students) in the Dentistry program at the Catholic University aged 18 to 25 who voluntarily meet the inclusion criteria. The sample size will be 21 participants in each group, but it will be adjusted for a 15% loss of information or study dropout, thus requiring 25 participants in each group. Participants who meet the selection criteria will be probabilistically assigned using simple random sampling through a lottery system to four groups: the first group (G1) will consume xylitol chewing gum, the second group (G2) will consume sugar-free gum, the third group (G3) will consume sugared gum, and the fourth group (G4), the control, will chew paraffin.
Saliva samples will be taken between 8 to 10 am, taking into account that subjects should not have ingested food, smoked, or brushed their teeth at least 1 hour prior to sample collection. They will be asked to rinse their mouth with pure water to remove any food residue. Subsequently, they will be seated in a chair in an upright position with the head slightly tilted forward and eyes open, and the basal saliva sample will be taken as indicated by the established protocol of the collection method for unstimulated saliva by Tomas Seif. Before starting the test, they will be asked to swallow saliva, keep their mouth slightly open, and allow saliva to drain into the tube. The test lasts for five minutes and the salivary pH will be evaluated and recorded, labeled as T1. For stimulated saliva, the protocol dictated by the Faculty of Dentistry at the University of Southern California will be used. Through the drainage method, stimulated saliva will be collected in another pre-weighed test tube at three more time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after starting chewing gum consumption. The Measurement of saliva pH level will be evaluated immediately using a pH meter (BT-675 meter, Boeco-Germany), while the salivary flow will be evaluated by the difference in weight of the basal pH with the final pH.
Data will be entered into an Excel spreadsheet and data analysis will be performed. The analysis will be conducted using SPSS v.25, with descriptive data analysis. Chi-square test will be used for demographic data, Levene's test will determine data homogeneity, and ANOVA will determine differences in means, followed by Tukey's post-hoc comparison to find significant differences between group means, with a significance level of p<0.05.
The expected results, that the mean salivary pH and flow will differ among the different chewing gums
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- It will be an experimental study through a double-blind parallel randomized controlled trial. All saliva samples will be collected using the spitting method. Each participant will provide a basal saliva sample for 5 minutes. Participants must meet the following inclusion criteria: having at least 20 teeth, providing written informed consent, and being willing to comply with the study procedures. The exclusion criteria will include individuals with systemic, infectious, or inflammatory diseases or those taking medications, antibiotics, or fluoride in the last month; regular consumers of products and mouthwashes containing xylitol or sorbitol, with abnormal salivary flow (<1 ml/min), pregnant women or those on contraceptive pill treatment, or with abnormal dietary habits; subjects with periodontal disease or presence of dental caries
| Arm | Type | Receives |
|---|---|---|
| G1: Gum of Xylitol | Experimental | Other: Gum of XylitolThey will consume chewing gum with xylitol (Xylichew), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption |
| G2: Gum of sugar free | Active comparator | Other: Gum of sugar freeThey will consume sugar-free chewing gum (Trident), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption |
| G3: Gum of sugar | Active comparator | Other: Gum of sugarFormed by participants who will chew sugared gum (Agogó), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing gum consumption |
| G4: paraffin wax | Placebo comparator | Other: Paraffin waxThe control group will chew paraffin wax (Dentek), and stimulated saliva will be collected at three time intervals: T2 from 5 to 10 minutes, T3 from 15 to 20 minutes, and T4 from 25 to 30 minutes after the start of chewing paraffin wax |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must meet at least 20 teeth.
- Providing written informed consent. and being willing to comply with the study procedures.
- Being willing to comply with the study procedures
Key exclusion criteria (7 listed)
- Individuals with systemic, infectious, or inflammatory diseases
- Individuals who are taking medications, antibiotics, or fluoride in the last month.
- Regular consumers of products and mouthwashes containing xylitol or sorbitol.
- Individuals with abnormal salivary flow (<1 ml/min).
- Pregnant women or those on contraceptive pill treatment.
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 |
|---|---|---|
| Gum of XylitolAfter each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow | Other | G1: Gum of Xylitol |
| Gum of sugar freeAfter each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow | Other | G2: Gum of sugar free |
| Gum of sugarAfter each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow | Other | G3: Gum of sugar |
| Paraffin waxAfter each sample, the salivary pH level will be measured, and the amount of basal saliva will be weighed. This amount will be subtracted from the accumulated saliva at T4 to establish salivary flow | Other | G4: paraffin wax |
Primary outcome
G1: Gum of xilytol
Time frame: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
G2: Gum of sugar free
Time frame: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
G3: Gum of sugar
Time frame: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
G4: Parafinn wax
Time frame: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.
Measurement of basal salivary pH (T1), salivary pH at T2, salivary pH at T3, salivary pH at T4. Each Falcon tube will be weighed empty, with basal saliva, and at time T4, and then the difference will be established to determine salivary flow.
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 14 Mar 2025.
- Results publication: PubMed 28898520Giacaman RA. Sugars and beyond. The role of sugars and the other nutrients and their potential impact on caries. Oral Dis. 2018 Oct;24(7):1185-1197. doi: 10.1111/odi.12778. Epub 2017 Oct 6.
- Results publication: PubMed 28762353Vantipalli UK, Avula SSJ, Enuganti S, Bandi S, Kakarla P, Kuravadi RV. Effect of three commercially available chewing gums on salivary flow rate and pH in caries-active and caries-free children: An in vivo study. J Indian Soc Pedod Prev Dent. 2017 Jul-Sep;35(3):254-259. doi: 10.4103/JISPPD.JISPPD_256_16.
- Results publication: PubMed 32665816Shinde MR, Winnier J. Comparative evaluation of Stevia and Xylitol chewing gum on salivary Streptococcus mutans count - A pilot study. J Clin Exp Dent. 2020 Jun 1;12(6):e568-e573. doi: 10.4317/jced.55720. eCollection 2020 Jun.
- Results publication: PubMed 30598728Rafeek R, Carrington CVF, Gomez A, Harkins D, Torralba M, Kuelbs C, Addae J, Moustafa A, Nelson KE. Xylitol and sorbitol effects on the microbiome of saliva and plaque. J Oral Microbiol. 2018 Oct 23;11(1):1536181. doi: 10.1080/20002297.2018.1536181. eCollection 2019.
- Results publication: PubMed 29947271Zimmer S, Spyra A, Kreimendahl F, Blaich C, Rychlik R. Elevating the use of sugar-free chewing gum in Germany: cost saving and caries prevention. Acta Odontol Scand. 2018 Aug;76(6):407-414. doi: 10.1080/00016357.2018.1487994. Epub 2018 Jun 27.
- Results publication: PubMed 25744362Hashiba T, Takeuchi K, Shimazaki Y, Takeshita T, Yamashita Y. Chewing xylitol gum improves self-rated and objective indicators of oral health status under conditions interrupting regular oral hygiene. Tohoku J Exp Med. 2015 Jan;235(1):39-46. doi: 10.1620/tjem.235.39.
- Results publication: PubMed 23790138Keukenmeester RS, Slot DE, Putt MS, Van der Weijden GA. The effect of medicated, sugar-free chewing gum on plaque and clinical parameters of gingival inflammation: a systematic review. Int J Dent Hyg. 2014 Feb;12(1):2-16. doi: 10.1111/idh.12026. Epub 2013 Jun 24.
- Results publication: PubMed 11913502Tapiainen T, Renko M, Kontiokari T, Uhari M. Xylitol concentrations in the saliva of children after chewing xylitol gum or consuming a xylitol mixture. Eur J Clin Microbiol Infect Dis. 2002 Jan;21(1):53-5. doi: 10.1007/s10096-001-0654-4.
- Results publication: PubMed 18460678Navazesh M, Kumar SK; University of Southern California School of Dentistry. Measuring salivary flow: challenges and opportunities. J Am Dent Assoc. 2008 May;139 Suppl:35S-40S. doi: 10.14219/jada.archive.2008.0353.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) underlying the results of the publication will be shared.
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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.
Miriam Lima, PhD principal investigator
Universidad Católica de Cuenca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gum of Xylitol, Gum of sugar free and Gum of sugar in people with Healthy, run by Universidad Católica de Cuenca at 1 site in Ecuador.
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 3 inclusion and 7 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 14 Mar 2025. 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 Ecuador. 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.
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?
G1: Gum of xilytol (time frame: The trial period for each participant is 35 minutes in total. Salivary pH at 10 minutes, salivary pH at 20 minutes, salivary pH at 30 minutes. Basal salivary volume and salivary volume at 35 minutes.). The study lists 4 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 NCT06370091, which also lists 9 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 14 Mar 2025.