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Active, Not Recruiting

NCT Number: NCT06365047

Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

This is a clinical investigation to measure the changes in the oral environment resulting from a 3 month exposure to an arginine containing toothpaste. This study is a double blind, randomized controlled, parallel design. Seventy (70) male and female subjects who meet the inclusion/exclusion criteria will be enrolled in the study. Following oral health evaluations, subjects will be assigned to the treatment schedule and receive their assigned study product.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female volunteers 18- 80 years of age and in general good health.
  • Willing and able to understand and sign the informed consent form.
  • Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
  • Be willing to conform to the study protocol and procedures.
  • Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
  • Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
  • Minimum of 10 teeth

Exclusion criteria

  • Subjects unable to understand or unwilling to sign the informed consent form.
  • Medical condition which requires premedication prior to dental visits/procedure.
  • Active disease of the hard or soft oral tissues.
  • History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study start.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Subjects who must receive dental treatment during the study dates.
  • Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
  • Presence of orthodontic bands.
  • Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
  • Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months).
  • People on hormone therapy
  • Pregnant or lactating subjects.
  • Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
  • Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Treatment and study plan

8% Arginine toothpaste

Device

Investigative

1000 ppm F toothpaste

Drug

Control

Primary outcomes

  1. Salivary pH Impact

    Time frame: 12 weeks

    The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the salivary pH of people with xerostomia.

Secondary outcomes

  1. Measuring the change in the oral microbiome

    Time frame: 12 weeks

    The objective of this clinical research study is to determine if the use of an Arginine containing toothpaste alters the oral microbiome (salivary and whole mouth plaque) of people with xerostomia.

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

  • Colgate Palmolive

Registry information

Official study title

Clinical Investigation to Measure the Changes in the Oral Environment Resulting From a 12 Weeks Exposure to an Arginine Containing Toothpaste

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Apr 15, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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