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Biotene Spray, followed by Refresh Spray for Dry Mouth

N/A

Waitlist Available

Led By Jonas T Johnson, MD

Research Sponsored by Jonas Johnson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial is looking at the effectiveness of two mouth sprays in relieving symptoms of xerostomia (dry mouth) in patients who have received radiation therapy for head and neck cancer. Quality of life and mouth acidity will also be assessed following use of the mouth sprays.

Eligible Conditions

Dry Mouth After Radiation Therapy
Head and Neck Cancers
Dry Mouth

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oral Dryness

Secondary outcome measures

Difficulty Wearing Dental Prostheses (if Applicable)

Saliva PH

Sleeping Difficulty Due to Oral Dryness

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Refresh Spray, followed by Biotene SprayExperimental Treatment2 Interventions

The Refresh Spray, followed by Biotene Spray Arm will be asked to complete a 2 week trial using Refresh Spray first, then will be asked to complete a 2 week trial using Biotene Spray second. (after the appropriate 1 week washout periods have been completed)

Group II: Biotene Spray, followed by Refresh SprayExperimental Treatment2 Interventions

The Biotene Spray followed by Refresh Spray Arm will be asked to complete a 2 week trial using Biotene Spray first, then will be asked to complete a 2 week trial using Refresh Spray second. (after the appropriate 1 week washout periods have been completed)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Alcohol-Free Moisturizing Dry Mouth Spray

2021

N/A

~130

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jonas JohnsonLead Sponsor

1 Previous Clinical Trials

26 Total Patients Enrolled

jonas johnsonLead Sponsor

TJA Health, LLCUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities to enrol in this research endeavor presently?

"Affirmative. According to clinicaltrials.gov, this research effort that first appeared on January 14th 2021 is currently recruiting participants. A total of 110 people are needed from two different sites."

Answered by AI

To what extent is this clinical trial being administered to participants?

"Affirmative. Clinicaltrials.gov reveals that this research study, which was first launched on January 14th 2021, is presently seeking participants. A total of 110 individuals must be enrolled from two separate medical facilities."

Answered by AI

Recent research and studies

Supportive Care in CancerJournal

A Phase II Study of Biotene in the Treatment of Postradiation Xerostomia in Patients with Head and Neck Cancer

Warde, P., B. Kroll, B. O'Sullivan, J. Aslanidis, E. Tew-George, J. Waldron, W. Maxymiw, F.-F. Liu, D. Payne, and B. Cummings. 2000. “A Phase II Study of Biotene in the Treatment of Postradiation Xerostomia in Patients with Head and Neck Cancer”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s005200050286.

Seminars in Radiation OncologyJournal

How Should We Measure and Report Radiotherapy-induced Xerostomia?

EISBRUCH, A, N RHODUS, D ROSENTHAL, B MURPHY, C RASCH, S SONIS, C SCARANTINO, and D BRIZEL. 2003. “How Should We Measure and Report Radiotherapy-induced Xerostomia?”. Seminars in Radiation Oncology. Elsevier BV. doi:10.1016/s1053-4296(03)00033-x.

Oral OncologyJournal

A Double-blind Crossover Trial of Oral Balance Gel and Biotene® Toothpaste Versus Placebo in Patients with Xerostomia Following Radiation Therapy

Epstein, J. 1999. “A Double-blind Crossover Trial of Oral Balance Gel and Biotene® Toothpaste Versus Placebo in Patients with Xerostomia Following Radiation Therapy”. Oral Oncology. Elsevier BV. doi:10.1016/s1368-8375(98)00109-2.

clinicaltrials.govStudy