Clinical trial NCT06370091: Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults
Official title: Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Chewing gum
Xylitol
Sugars
Salival
Dental Plaque
Lead sponsor: Universidad Católica de Cuenca
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: G1: Gum of xilytol
timeFrame: 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.
measure: G2: Gum of sugar free
timeFrame: 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.
measure: G3: Gum of sugar
timeFrame: 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.
measure: G4: Parafinn wax
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cuenca
country: Ecuador
facility: Miriam Lima
state: Azuay
Study officials:
affiliation: Universidad Católica de Cuenca
name: Miriam Lima, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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