Development of a Novel Anti-caries Chewing Gum

NCT ID: NCT05946473

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-04-30

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.

Conditions

Dental Plaque; Dental Caries; Periodontal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental gum formulation

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

Group Type: EXPERIMENTAL

Gum base containing xylitol and essencial oils

Intervention Type: 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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Gum base with no additives

Intervention Type: 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

Interventions

Gum base containing xylitol and essencial oils

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

Intervention Type: DIETARY_SUPPLEMENT

Gum base with no additives

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Dennis Cvitkovitch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

44196

Identifier Type: -

Identifier Source: org_study_id