Effect of Xylitol-based Chewing Gums, Sugar-free and Sugared, on Salivary Flow and pH in Young Adults

NCT06370091 | Completed DMC

• 1 other identifier: PICVII19-41
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Chewing gum; Xylitol; Sugars; Salival; Dental Plaque

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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.

Study Arms (4)

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

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

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

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

Other: Paraffin wax

Interventions

Gum of Xylitol OTHER

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

G1: Gum of Xylitol

Gum of sugar free OTHER

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

G2: Gum of sugar free

Gum of sugar OTHER

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

G3: Gum of sugar

Paraffin wax OTHER

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

G4: paraffin wax

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica de Cuenca: lead

Study Sites (1)

Miriam Lima

Cuenca, Azuay, 010101, Ecuador

Location

Related Publications (9)

• 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.

  PMID: 28898520 RESULT

• Vantipalli 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.

  PMID: 28762353 RESULT

• Shinde 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.

  PMID: 32665816 RESULT

• Rafeek 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.

  PMID: 30598728 RESULT

• Zimmer 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.

  PMID: 29947271 RESULT

• Hashiba 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.

  PMID: 25744362 RESULT

• Keukenmeester 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.

  PMID: 23790138 RESULT

• Tapiainen 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.

  PMID: 11913502 RESULT

• Navazesh 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.

  PMID: 18460678 RESULT

MeSH Terms

Conditions

Dental Plaque

Interventions

Paraffin

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Miriam Lima, PhD

  Universidad Católica de Cuenca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants who meet the selection criteria will be probabilistically assigned using simple random sampling through a lottery system. An urn will be used to draw colors corresponding to a type of chewing gum
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Stomatological Sciences

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 17, 2024
• Study Start: December 12, 2023
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: March 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available from July 2024 to January 2025.
• Access Criteria: The data will be shared with anyone requesting it via email, stating the purpose of the request

Locations

EC (1)