Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health

NCT02999230 | Completed

• 2 other identifiers: IRB201602471-N5R01DE025832-05
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

Cavities

Outcome Measures

Primary Outcomes (5)

• Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2

  Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.

  Changes from baseline to 2 weeks (Screening)

• Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4

  Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.

  Changes from week 2 to week 4 (Baseline)

• Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8

  Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.

  Changes from week 4 to week 8 (Washout)

• Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12

  Saliva and dental plaque will be collected during the week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols

  Changes from week 8 to week 12 (Evaluation)

• Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.

  Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.

  Changes from baseline to week 12 (Evaluation)

Secondary Outcomes (5)

• Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2

  Changes from baseline to week 2

• Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4

  Changes from week 2 to week 4

• Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8

  Changes from week 4 to week 8

• Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12

  Changes from week 8 to week 12

• Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12

  Changes from baseline to week 12

Other Outcomes (1)

• Salivary factors present in healthy and caries-active subjects during the research study.

  Up to 6 months

Study Arms (4)

Caries Free

ACTIVE COMPARATOR

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

Other: Caries Free 1.5% Arginine

Caries Free- Placebo

PLACEBO COMPARATOR

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

Other: Caries Free Placebo Sodium Fluoride

Caries Active

ACTIVE COMPARATOR

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

Other: Caries Active 1.5% Arginine

Caries Active- Placebo

PLACEBO COMPARATOR

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

Other: Caries Active- Placebo Sodium Fluoride

Interventions

Caries Free 1.5% Arginine 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.

Also known as: 1.5% Arginine

Caries Free

Caries Free Placebo Sodium Fluoride 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.

Also known as: Sodium Fluoride

Caries Free- Placebo

Caries Active 1.5% Arginine 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.

Also known as: 1.5% Arginine

Caries Active

Caries Active- Placebo Sodium Fluoride 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.

Also known as: Sodium Fluoride

Caries Active- Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Arginine; Sodium Fluoride

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential; Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Sodium Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Marcelle Nascimento, DDS, MS PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 21, 2016
• Study Start: February 22, 2017
• Primary Completion: June 25, 2020
• Study Completion: June 25, 2020
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)