RECRUITING

Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-31

Study Completion:2027-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06365047

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female volunteers 18- 80 years of age and in general good health. 2. Willing and able to understand and sign the informed consent form. 3. Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months. 4. Be willing to conform to the study protocol and procedures. 5. Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?"). 6. Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min. 7. 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. 8. Minimum of 10 teeth	1. Subjects unable to understand or unwilling to sign the informed consent form. 2. Medical condition which requires premedication prior to dental visits/procedure. 3. Active disease of the hard or soft oral tissues. 4. History of salivary gland disease such as Sjogren's syndrome, Sarcoidosis, or Head and Neck Radiation Therapy. 5. Use of antibiotics or antimicrobial drugs within 30 days prior to study start. 6. Participation in any other clinical study within 1 week prior to enrollment into this study. 7. Subjects who must receive dental treatment during the study dates. 8. Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy). 9. Presence of orthodontic bands. 10. Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1) 11. Use of pilocarpine or other cholinergic stimulating receptor actives prescribed after study enrollment or whose medication dose increases (stable dose for 3 months). 12. People on hormone therapy 13. Pregnant or lactating subjects. 14. Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits; 15. Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Inclusion Criteria

Exclusion Criteria

1. Male or female volunteers 18- 80 years of age and in general good health.
2. Willing and able to understand and sign the informed consent form.
3. Subjects currently taking at least two medications known to cause xerostomia (dry mouth) as a side effect for the last three months.
4. Be willing to conform to the study protocol and procedures.
5. Polypharmacy subjects must score 4 or more on the VAS scale of 0-10 ("How severe is your dryness right now?").
6. Flow of 5 minutes unstimulated saliva should be below 0.16 ml/min.
7. 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.
8. Minimum of 10 teeth

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

Contacts and Locations

Study Contact

Athena Papas, DMD, PhD

CONTACT

617-636-3931

dentalresearchadministration@tufts.edu

Ann-Marie Billig

CONTACT

6173632408

dentalresearchadministration@tufts.edu

Principal Investigator

Athena Papas, DMD, PhD

PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Study Locations (Sites)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111

United States

Collaborators and Investigators

Sponsor: Tufts University

Athena Papas, DMD, PhD, PRINCIPAL_INVESTIGATOR, Tufts University School of Dental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-31

Study Completion Date2027-06-01

Study Record Updates

Study Start Date2024-08-31

Study Completion Date2027-06-01

Terms related to this study

Additional Relevant MeSH Terms

Xerostomia