Development of a Novel Anti-caries Chewing Gum

Sponsor

University of Toronto (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05946473

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Plaque Dental Caries Periodontal Disease	Dietary Supplement: Gum base containing xylitol and essencial oils Dietary Supplement: Gum base with no additives	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Development of a Novel Anti-caries Chewing Gum

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Dietary Supplement: 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
Placebo Comparator: 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.	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

Arm

Intervention/Treatment

Experimental: 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

Dietary Supplement: 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

Placebo Comparator: 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.

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Toronto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dennis Cvitkovitch, Professor, University of Toronto

ClinicalTrials.gov Identifier:

NCT05946473

Other Study ID Numbers:

44196

First Posted:

Jul 14, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Periodontal Diseases

Dental Plaque

Study Results

No Results Posted as of Jul 14, 2023