Dry Mouth

About Dry Mouth Clinical Trials (Click to Open)

Join Clinical Trials for Dry Mouth

General Purpose:

Chronic dry mouth (also known as xerostomia) can be bothersome from a symptom-related standpoint, as well as detrimental to the health of your teeth. It can also have a negative impact on your ability to eat and enjoy certain foods.

The reasons for these complications are two-fold. First, saliva serves as the body’s primary line of defense against the bacteria that cause tooth decay, by helping to wash away particles of food. In addition, saliva enhances an individual’s ability to taste, makes it easier to chew swallowed food, and promotes digestion. 

Dry mouth commonly occurs as a side effect of medicine and in such cases, it can likely be improved by adjusting the dose of the medicine or switching to a different drug altogether. Drugs that are likely to cause dry mouth include those used to treat depression and anxiety, antihistamines, decongestant medications, blood-pressure lowering drugs, drugs to relive diarrhea, and muscle relaxants.

Apart from medications, other possible causes include aging, chemotherapy, damage to the nerves in the head and neck, and health conditions such as Sjogren’s syndrome, diabetes, Parkinson’s disease, and HIV/AIDS. Additionally, tobacco use can worsen symptoms of existing dry mouth.

Research related to dry mouth is currently focused on discovering ways to help relieve dry mouth that occurs in response to chemotherapy for cancer, as well as more effective ways to treat that which occurs as a side effect of various medications. Researchers are also working to better understand how the salivary glands malfunction in an effort to discover information that may be of use in developing future and more targeted treatments.

What Will Dry Mouth Clinical Trials Be Like?

The types of tests and assessments used in dry mouth clinical trials will ultimately depend on the specific nature of the study. Provided below is a list of frequent procedures and tests used to evaluate dry mouth, many of which may be incorporated for use in clinical trials:

  • Detailed exam of the teeth, mouth, and gums.
  • Detailed review of your medical history.
  • Blood tests to look for indications of an underlying disease or condition that may be causing the symptoms of dry mouth.
  • Computed tomography (CT or “CAT” scan) or magnetic resonance imaging (MRI), which are non-invasive imaging procedures that take detailed pictures of areas inside the body. These tests may be used to visualize your salivary glands.
  • Tests to measure how much saliva you produce.
  • You will likely be asked to avoid eating, drinking, chewing gum, smoking, and brushing your teeth for a specific period of time before any study-related evaluations.
  • You may be asked to maintain a log of your diet, as well as behaviors such as smoking, gum chewing, use of mints and mouthwash.
  • You may be asked to complete brief questionnaires to evaluate your quality of life and/or level of depression and/or anxiety.
  • You may be asked to rinse your mouth with an oral solution (similar to mouthwash) a specified number of times per day, depending on the purpose of the study.
  • Swab of the inner cheeks, teeth, gums and/or tongue to obtain bacteria samples for analysis.

Typical Dry Mouth Clinical Trial Protocol: 

Specific examples of clinical trials for dry mouth might include the following:

  • A randomized clinical trial that randomly assigns patients to receive one of four commercially-available remedies for dry mouth or a placebo in order to determine the degree of effectiveness for each remedy. In such a study, the degree of effectiveness would be determined by collecting saliva samples to measure output as well as collecting subjective information from patients via a questionnaire.
  • A clinical trial to determine if the surgical relocation of the salivary gland out of the area that will undergo radiation is effective at protecting the gland from radiation-induced injury during radiation treatment for head and neck cancer.
  • A randomized clinical trial in which patients with Sjogren’s syndrome are randomly assigned to receive treatment with a new drug that is designed to increase the production of saliva or to receive sham treatment with a placebo.
  • An observational study in which patients with dry mouth undergo a dental examination, wear a bacteria collection device attached to the side of a tooth for 48 hours, and then receive a teeth cleaning and polishing. The purpose of such a study would be to examine the types of bacteria that are present in the plaque of patients who suffer from dry mouth.

A brief word about randomized trials and placebos: 

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it. 

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated (such as the third clinical trial example provided above), the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of dry mouth (length, severity, etc.)
  • Your history of tooth and/or gum disease
  • Your history of treatment for dry mouth, tooth and/or gum disease
  • Your prior and current diagnoses of any health conditions or diseases
  • Your current medications (including vitamins and other dietary supplements)

Suggested Search Terms:

“dry mouth prevention,” “dry mouth management,” “dry mouth treatment,” “dry mouth diet,” “dry mouth cancer,” “dry mouth radiation therapy,” “dry mouth side effect,” and “dry mouth side medication.”

Current Search Term:

“Dry Mouth”

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"Hyaluronan" Formulation for Dry Mouth in Sleep Apnea Patients


Conditions:   Dry Mouth;   Xerostomia;   OSA;   Sleep Apnea
Interventions:   Device: Test Oral Spray;   Device: Placebo Oral Spray
Sponsor:   You First Services
Recruiting


"Hyaluronan" Formulation for Type 2 Diabetic Patients With Dry Mouth


Conditions:   Dry Mouth;   Xerostomia;   Type 2 Diabetics
Interventions:   Device: HA formulation Oral Spray;   Device: Placebo
Sponsor:   You First Services
Not yet recruiting


Effectiveness of an Intervention Bundle on Thirst Intensity and Dry Mouth Among Patients in ICUs


Conditions:   Thirst;   Dry Mouth
Intervention:   Other: Intervention bundle
Sponsor:   Maharishi Markendeswar University
Completed


Coconut Oil: Managing Radiation-Induced Xerostomia


Condition:   Xerostomia
Intervention:   Other: Coconut Oil
Sponsor:   Ottawa Hospital Research Institute
Not yet recruiting


Salivary Markers in Patients With Xerostomia


Condition:   Xerostomia Due to Hyposecretion of Salivary Gland
Intervention:   Diagnostic Test: Analysis of the saliva
Sponsor:   Universidad de Murcia
Recruiting


Stromal Vascular Fraction for Treatment of Xerostomia


Condition:   Xerostomia Due to Radiotherapy (Disorder)
Interventions:   Biological: Stromal Vascular Fraction;   Other: Usual Care
Sponsor:   Midwestern Regional Medical Center
Suspended


Efficacy of Oral Moisturizing Jelly on Oral Health and Nutrition in Post-radiotherapy Head and Neck Cancer Patients


Conditions:   Cancer of Head Neck;   Radiation-Induced Xerostomia;   Dry Mouth
Interventions:   Dietary Supplement: Oral moisturizing jelly;   Other: Artificial saliva
Sponsors:   Dental Innovation Foundation Under Royal Patronage;   Mahidol University;   Srinakharinwirot University;   Ministry of Health, Thailand
Recruiting


Validation of the French Version of the Xerostomia Inventory


Condition:   Xerostomia
Intervention:   Other: Measurement of salivary flow
Sponsor:   CHU de Reims
Recruiting


Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects


Condition:   Xerostomia
Interventions:   Other: Biotene mouthwash;   Other: Bottled mineral water
Sponsor:   GlaxoSmithKline
Completed


Effect of Pilocarpine in Patients With Xerostomia


Condition:   Xerostomia
Interventions:   Drug: Pilocarpine;   Other: Spray without Pilocarpine
Sponsor:   University of Sao Paulo
Recruiting


A Trial Looking at Treating Dry Mouth After Radiotherapy for Head and Neck Cancer


Conditions:   Xerostomia;   Head and Neck Neoplasms
Interventions:   Device: Active Electrostimulator device;   Device: Sham Electrostimulator device
Sponsor:   University College, London
Completed


Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.


Condition:   Xerostomia
Interventions:   Other: Dairy product;   Device: Aequasyal mouth spray
Sponsors:   Centre Hospitalier Universitaire de Besancon;   Ecole Nationale de l'Industrie Laitière (ENIL);   Centre Hospitalier Universitaire Dijon
Recruiting


A Study of Patients With Dry Mouth and Sticky Saliva During Radiotherapy


Condition:   Xerostomia
Interventions:   Device: Visco-ease;   Device: Placebo
Sponsors:   NHS Greater Glasgow and Clyde;   Lamellar Biomedical Ltd;   University of Glasgow
Completed


Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation


Condition:   Xerostomia
Intervention:  
Sponsor:   UNC Lineberger Comprehensive Cancer Center
Recruiting


Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms


Condition:   Xerostomia
Interventions:   Other: Biotene mouthwash;   Other: Mineral Water
Sponsor:   GlaxoSmithKline
Completed


Trial of Acupuncture for Radiation-Induced Xerostomia in Head and Neck Cancer


Condition:   Radiation-Induced Xerostomia
Interventions:   Other: Standard Oral Hygiene;   Other: Standard Oral Hygiene + True Acupuncture;   Other: Standard Oral Hygiene + Sham Acupuncture
Sponsor:   Wake Forest University Health Sciences
Recruiting


Use of Biotene Moisturizing Mouth Spray for Xerostomia Associated With Oral Oxybutynin Use


Conditions:   Overactive Bladder;   Xerostomia;   Compliance
Intervention:   Drug: Biotene oral spray
Sponsor:   University of Southern California
Not yet recruiting


Mesenchymal Stemcells for Radiation Induced Xerostomia


Condition:   Xerostomia
Interventions:   Drug: Mesenchymal stem cell;   Drug: Isotonic NaCl
Sponsor:   Rigshospitalet, Denmark
Completed


Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer


Conditions:   Head and Neck Carcinoma;   Xerostomia
Interventions:   Other: Quality-of-Life Assessment;   Procedure: Transcutaneous Acupoint Electrical Stimulation
Sponsors:   Roswell Park Cancer Institute;   National Cancer Institute (NCI)
Active, not recruiting


A New Oral salIvary equivAlent Compared to Two moisturizinG Mouth sprAys in Patients With xeRostomiA: NIAGARA Study


Conditions:   Xerostomia;   Hyposalivation;   Head and Neck Cancer;   Sjögren Syndrome
Interventions:   Device: Salivary equivalent;   Device: Aequasyal;   Device: Biotene
Sponsor:   Unither Pharmaceuticals, France
Completed


Xerostomia Pilot Fudan: Acupuncture for Prevention of Radiation-Induced Xerostomia


Conditions:   Head and Neck Cancer;   Xerostomia
Intervention:   Other: Acupuncture
Sponsor:   M.D. Anderson Cancer Center
Recruiting


Hyperbaric Oxygen for the Treatment of a Dry Mouth Which Occurred After Radiotherapy


Condition:   Radiation-induced Xerostomia
Intervention:   Drug: Hyperbaric oxygen
Sponsors:   Thomas Kuhnt;   Verband Deutscher Druckkammerzentren
Terminated


Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer


Conditions:   Head and Neck Cancer;   Xerostomia
Interventions:   Drug: Pilocarpine;   Procedure: ALTENS
Sponsors:   Radiation Therapy Oncology Group;   National Cancer Institute (NCI);   NRG Oncology
Completed


Acupuncture for Prevention of Radiation-Induced Xerostomia


Conditions:   Xerostomia;   Mouth Dryness;   Nasopharyngeal Cancer
Interventions:   Procedure: Acupuncture;   Other: Standard Care
Sponsors:   M.D. Anderson Cancer Center;   National Cancer Institute (NCI)
Active, not recruiting


Salivary Gland Surgery Before Radiation Therapy in Preventing Radiation-Caused Xerostomia in Patients With Head and Neck Cancer


Conditions:   Head and Neck Cancer;   Radiation Toxicity;   Xerostomia
Interventions:   Procedure: Surgery for the primary and neck nodes;   Procedure: Submandibular salivary gland transfer;   Radiation: Post-operative radiation therapy
Sponsors:   Radiation Therapy Oncology Group;   National Cancer Institute (NCI)
Completed

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