Development of a Novel Anti-caries Chewing Gum

University of Toronto

Status: Not yet enrolling

Conditions: Dental Caries; Dental Plaque; Periodontal Disease

Treatments: Dietary Supplement: Gum base with no additives; Dietary Supplement: Gum base containing xylitol and essencial oils

Study type: Interventional

Funder types: Other

Identifiers

NCT05946473

44196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Experimental gum formulation

Experimental group

Description:

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

Treatment:

Dietary Supplement: Gum base containing xylitol and essencial oils

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Gum base with no additives