Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

NCT ID: NCT02999230

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2020-06-25

Brief Summary

This study will examine the mechanisms of action of probiotics and synbiotics for control of oral diseases, with a particular focus on exploring new strategies for caries prevention and treatment.

Detailed Description

Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow the research visit protocol listed below:

Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be consider Visit 1 (Baseline).

Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. This will be the end of the study for subjects recruited in years 1, 2, and 4.

Subjects will be grouped by the year they participate in the study. Subjects recruited in year 3 will follow the research visit protocol outlined below:

Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be considered Visit 1 (Baseline).

Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. Each subject will be given a toothbrush and toothpaste and instructed to not use any other dental products. This will be considered the "washout" period.

Visit 2 - The subject will be asked to return the unused toothpaste. Their medical and dental history will be reviewed and they will have their teeth examined. Saliva and plaque will be collected at this visit. The subjects will then be randomly assigned (by chance, like the flip of a coin) to the group that will use a marketed fluoride-containing toothpaste or to the group that will use a marketed arginine containing toothpaste. The subject will also be instructed not to brush or floss their teeth or eat or drink anything other than water for 8 hours prior to the next appointment.

Visits 3, 4, and 5 - Subjects will not be allowed to brush or floss their teeth or eat or drink anything other than water 8 hours prior to these visits. Saliva and plaque will be collected. On the 5th visit subjects will be asked to return the unused toothpaste tube. At this time participation in this research study will end and they will be instructed to return to their regular oral hygiene regiments.

Conditions

Dental Caries

Study Design

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

Study Groups

Caries Free

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Study toothpaste will be assigned.

Group Type: ACTIVE_COMPARATOR

Caries Free 1.5% Arginine

Intervention Type: OTHER

Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Caries Free- Placebo

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Group Type: PLACEBO_COMPARATOR

Caries Free Placebo Sodium Fluoride

Intervention Type: OTHER

Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Caries Active

Gums will be examined and caries assessment performed. On some visits Saliva and plaque will be collected. Study toothpaste will be assigned.

Group Type: ACTIVE_COMPARATOR

Caries Active 1.5% Arginine

Intervention Type: OTHER

Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Caries Active- Placebo

Gums will be examined and caries assessment performed. On some visits Saliva and supragingival plaque will be collected. Marketed Toothpaste will be assigned.

Group Type: PLACEBO_COMPARATOR

Caries Active- Placebo Sodium Fluoride

Intervention Type: OTHER

Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Interventions

Caries Free 1.5% Arginine

Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Intervention Type: OTHER

Caries Free Placebo Sodium Fluoride

Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Intervention Type: OTHER

Caries Active 1.5% Arginine

Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Intervention Type: OTHER

Caries Active- Placebo Sodium Fluoride

Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.

Intervention Type: OTHER

Other Intervention Names

1.5% Arginine; Sodium Fluoride; 1.5% Arginine; Sodium Fluoride

Eligibility Criteria

Inclusion Criteria

• Twenty natural uncrowned teeth excluding third molars
• No contraindications to dental treatment
• Caries Free-(with no clinical evidence of past or present caries)
• Caries Active- (At least two active sites)

Exclusion Criteria

• Less than 20 teeth
• Systemic disease that can cause xerostomia
• Taking medication known to cause xerostomia
• Have been treated with antibiotics within the past 3 months
• Advanced periodontal disease
• Removable or fixed dental appliances
• Bleeding disorders or taking anticoagulant medications
• Immune compromised individuals
• Uses tobacco products
• Participation in another clinical study one week prior to the start of the washout period or during the study period
• Use of any flavored products, such as mint flavored candies and chewing gum, one week prior to or during the study
• Unwilling or unable to provide informed consent and follow plaque/saliva collection instructions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcelle Nascimento, DDS, MS PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida College of Dentistry

Gainesville, Florida, United States

Countries

United States

Other Identifiers

5R01DE025832-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201602471-N

Identifier Type: -

Identifier Source: org_study_id