Development of a Novel Anti-caries Chewing Gum

Not Applicable

Not yet recruiting

• Conditions: Periodontal Disease; Dental Caries; Dental Plaque
• Interventions: Dietary Supplement: Gum base containing xylitol and essencial oils; Dietary Supplement: Gum base with no additives

• Registration Number: NCT05946473
• Lead Sponsor: University of Toronto

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.

Detailed Description

The goal of this project is to develop a pre-biotic chewing gum that is designed to promote a healthy oral microbiome. The gum will contain compounds that will: a) be unable to be converted to acids; b) target the cariogenic S. mutans population; c) promote the stability of a healthy environment by modulating plaque pH via base-generating compounds; d) promote tooth remineralization by increasing saliva flow and by addition of calcium phosphate.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Last Update Submitted: 2023-07-06
• Study First Posted: 2023-07-14
• Last Update Posted: 2023-07-14
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental gum formulation	Gum base containing xylitol and essencial oils	Participants will be asked to chew 2 pieces of chewing gum containing additives 2 times a day for a four-week period
Placebo	Gum base with no additives	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.

Primary Outcome Measures

Name	Time	Method
Change in target species of the oral microbiome	28 days	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