Impact of an Arginine-containing Toothpaste on the Subgingival Microbiota in Patients in Supportive Periodontal Care

ConditionGum Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorSukirth M Ganesan, BDS, PhD

About this trial

This study aims to see how a toothpaste with arginine affects bacteria below the gum line compared to a regular fluoride toothpaste. It focuses on people with gum disease who are already getting ongoing dental care.

The main questions it aims to answer are:

* How does an arginine toothpaste affect the bacteria below the gumline? * How does a fluoride toothpaste affect the bacteria below the gumline?

Participants will:

* Use fluoride toothpaste or arginine toothpaste twice daily for 6 months * After receiving the toothpaste at the baseline visit, subjects will visit the clinic at 3 months and 6 months for additional data collection.

Eligibility criteria

Qualifiers

Understands and is willing to sign an Informed Consent, approved by the local Ethics Committee.

Female or male, ages 18-95 years old (inclusive)

Systemically healthy.

Presence of at least three evaluable teeth in each quadrant.

Disqualifiers

Untreated or uncontrolled periodontitis or advanced (advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive alveolar bone loss)

Antibiotics intake within the previous month.

Pregnant women and/or breastfeeding women

Any adverse medical history (controlled and uncontrolled diabetes, osteoporosis, immunosuppression…) or long-term medication (chemotherapy and immunosuppression treatment; pharmacological treatment associated with gingival overgrowth such as the use of phenytoin, phenobarbital, lamotrigine, vigabatrin, ethosuximide, topiramate, primidone, nifedipine, amlodipine, verapamil, cyclosporine) influencing gingival conditions.

Trial design

Treatments tested in this trial

  • Arginine Toothpaste
  • Fluoride Toothpaste

Treatment groups

108 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Sukirth M Ganesan, BDS, PhD

Lead sponsor

University of Iowa

Sponsor institution