NCT06363955Completed
Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing, Oral Hygiene and Xerostomia Relief
A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Carbamide Peroxide Mouthwash for Oral Wound Healing, Postoperative Symptoms, Xerostomia Relief, and Oral Hygiene Following Diagnostic Biopsy of Minor Labial Salivary Glands for Sjögren's Syndrome Investigation
Source: ClinicalTrials.gov · Last updated 3 Jul 2024
Brief summary (registry, in English)
The aim of this study is to evaluate the efficacy and safety of a carbamide peroxide mouthwash regarding oral wound healing, postoperative symptoms, xerostomia (dry mouth) and oral hygiene improvement. Study participants have reported dry mouth and are scheduled for a diagnostic biopsy of minor labial salivary glands to investigate Sjögren's Syndrome, following consultation with their rheumatologist. This is a standardized diagnostic procedure that leads to healing by primary intention (i.e. wound edges are closely re-approximated with sutures). Researchers are comparing this mouthwash with a placebo (a look-and-taste-alike substance that contains no active ingredients) to see if it is helpful with healing of wounds in the mouth and associated symptoms, improving dry mouth and/or oral hygiene. Carbamide peroxide breaks down to hydrogen peroxide and urea and shows antiseptic and antimicrobial properties and it might help with the parameters to be assessed. Participants randomly get the carbamide peroxide mouthwash or the placebo one to use for 14 days after the biopsy. The investigators will not know which one they are providing as the bottles will be identical. Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation), improvement of dry mouth and quality of life are assessed during a 14-day period after the biopsy. Participants are required to visit the clinic three times, one for the initial consultation and the biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (such as measuring saliva) and assessments (like evaluating the dental plaque and gingival inflammation) take place. During the first week they, also, keep a diary of their symptoms, as instructed.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 54 (actual)
- First submitted
- 5 Apr 2024
- Start date
- 25 Apr 2023
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- National and Kapodistrian University of Athens
- Diseases
- Sjögren's disease
- NCT number
- NCT06363955
What you commit to
- Study type: Interventional
- Participants enrolled: 54
- From 25 Apr 2023 to the primary completion date, 1 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently undergoing and/or has received radiation therapy to the head or neck (including radioactive iodine therapy)
- Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy
- Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis
- Use of any antimicrobial mouthwash in the last 1 month before the biopsy
- Concurrent immunocompromised status and/or use of immunosuppressant medications (e.g. corticosteroids) and steroid inhalers or nasal sprays within the last 1 month prior to enrollment
- Received dental treatment during the period included in the study
- Participation in another study of an investigational product or device until the primary endpoint is met
Other illness
- Presence or history of oral malignant lesions
- Existence of viral or other infections of the oral cavity or pathology that could interfere with the primary outcomes of the study (e.g. oral vesicobullous disorders)
- History of acute myocardial infarction and/or vascular stroke during the last 6 months
- Alcohol abuse and (illicit) drug use disorders
- Known allergy to any of the ingredients of the study products
- Other medical condition that, in the opinion of the investigator, may be causing the patient's non-compliance with the clinical investigation plan or confusion in interpreting the data
Lab values
- Patients with poor glycemic control (HbA1c ≥ 7% within the previous 3 months according to American Diabetes Association (ADA) recommendations), uncontrolled type I or II diabetes mellitus or other systemic diseases known to affect oral wound healing
Age
- Age \<18 years
Other
- Total number of teeth in the oral cavity \<10
- Existence of orthodontic appliances
- Current use of bleaching trays
- Use of sialagogues
- Heavy smokers (those who smoke greater than or equal to 25 cigarettes per day) and tobacco chewers or users of tobacco pouches
- Malnutrition
- Pregnancy or lactation/nursing/breast feeding
- Inability to provide informed consent
Who the study is looking for
- Age \>18 years
- Patients requiring lower lip salivary gland biopsy for investigation of Sjögren's syndrome
- Patients with subjective dry mouth, i.e. who have recorded ≥30mm in at least one of the first 4 questions of the VAS (Visual Analogue Scale) questionnaire according to Pai et al, 2001
- Able to use the study products (rinse - swish and spit)
- Agreeing to abstain from the use of any products for xerostomia other than the products provided by the study.
- Patients who are legally competent and able to understand the information about the study, have been informed of the nature, scope and utility of the study, voluntarily agree to participate and have signed the consent form.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry, National and kapodistrian University of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.