Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370091
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-06
Brief Title:
Effect of Xylitol-based Chewing Gums Sugar-free and Sugared on Salivary Flow and pH in Young Adults
Sponsor:
Universidad Católica de Cuenca
Organization:
Universidad Católica de Cuenca
Study Overview
Official Title:
Effect of Xylitol-based Chewing Gums Sugar-free and Sugared on Salivary Flow and pH in Young Adults Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 xylitolThe 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 v25 with descriptive data analysis Chi-square test will be used for demographic data Levenes test will determine data homogeneity and ANOVA will determine differences in means followed by Tukeys post-hoc comparison to find significant differences between group means with a significance level of p005
The expected results that the mean salivary pH and flow will differ among the different chewing gums
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 v25 with descriptive data analysis Chi-square test will be used for demographic data Levenes test will determine data homogeneity and ANOVA will determine differences in means followed by Tukeys post-hoc comparison to find significant differences between group means with a significance level of p005
The expected results that the mean salivary pH and flow will differ among the different chewing gums
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None