Development of a Novel Anti-caries Chewing Gum

NCT05946473 | Unknown

• 1 other identifier: 44196
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study is designed to evaluate the chewing gum's ability to modulate the oral microbiome in human participants, in addition to its safety.

Conditions

Dental Plaque; Dental Caries; Periodontal Disease

Outcome Measures

Primary Outcomes (1)

• Change in target species of the oral microbiome

  Total microbiome analyses will be performed at the beginning and end of the study (4 weeks) to assess total cultivable flora, levels of S. mutans, S. salivarius, and P. gingivalis in addition to using qRT-PCR from plaque and saliva samples

  28 days

Study Arms (2)

Experimental gum formulation

EXPERIMENTAL

Participants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period

Dietary Supplement: Gum base containing xylitol and essencial oils

Placebo

PLACEBO COMPARATOR

Participants will be asked to chew 2 pieces of pure gum base with no additives chewing gum 2 times a day for the same four-week period.

Dietary Supplement: Gum base with no additives

Interventions

Gum base containing xylitol and essencial oils DIETARY_SUPPLEMENT

Participants will be asked to chew 2 pieces of chewing gum containing additives for 10 minutes after eating in the morning, and after one meal in the evening, for a four-week period

Experimental gum formulation

Gum base with no additives DIETARY_SUPPLEMENT

Participants will be asked to chew 2 pieces of pure gum base for 10 minutes after eating in the morning, and after one meal in the evening, for a four-week period

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good general health, no relevant medical history
• No dental treatment in the previous 3 months
• Willing to participate and give written informed consent

You may not qualify if:

• Patients undergoing fixed or removable orthodontic treatment
• Patients using removable prosthesis
• History of head and neck radiation therapy
• History of adverse reaction or allergies to xylitol or other additives
• Antibiotics use in the last four weeks
• Patients with any systemic diseases
• Xerostomia (also medication-induced)
• Smokers
• Currently using any mouth rinse
• Pregnant or breastfeeding women

Sponsors & Collaborators

• University of Toronto: lead

MeSH Terms

Conditions

Dental Plaque; Dental Caries; Periodontal Diseases

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-07