NCT06363955

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, randomized, triple-blind, placebo-controlled clinical trial and post-market clinical follow-up (PMCF) study, expected to last approximately 12 months. All procedures/visits/examinations are taking place in the Oral Medicine and Pathology Clinic at the School of Dentistry, National and Kapodistrian University of Athens, Greece. Participants with reported dry mouth 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. After checking if they comply with the study's criteria, they are informed about the study and the biopsy procedure (including possible complications) and they sign the Ιnformed Consent Form. All biopsies are obtained from the lower lip with a 12 - 15 mm linear incision. After blunt dissection of the borders, 5-7 lobules of minor salivary glands are removed by dissection with the scalpel or a curved mosquito forceps and the use of tweezers. Attention is paid not to injure nerve branches or vessels. Adequate hemostasis is achieved by manual pressure, and the incision is closed by simple interrupted non-absorbable 4/0 silk sutures at equal distances. Participants are instructed to have cold, soft diet for the day and use ice packs externally for 1-2 hours after the procedure. Use of 500mg paracetamol up to 3 times is permitted for day 0. Following their normal oral hygiene routine (brushing and toothpaste) is suggested. Subsequently, they are assigned randomly in a 1:1 ratio to receive either a carbamide peroxide mouthwash or a placebo comparator, i.e. a look-alike substance that lacks active ingredients. Both participants and investigators are masked. Follow-up examinations are conducted at 7 and 14 days. On day 7 the sutures are cut. The evaluation includes: • oral wound healing (primary intention) assessed by scores (primary outcome) and secondarily: * oral wound healing via measuring the incision/wound length * postoperative symptoms (such as pain, eating and speech difficulties) * quality of life assessed by a questionnaire * improvement of dry mouth through subjective and objective measurements * oral hygiene via plaque and gingival indices. All data are anonymized and the outcome assessors are masked. The mouthwash used in the experinmental/test group is a Class IIa, CE-marked (Conformité Européenne) medical device. This mouthwash contains hydrogen carbamide that breaks down to hydrogen peroxide and urea. Hydrogen peroxide has antiseptic and antimicrobial properties, as well the ability to mechanically clean affected areas by producing an oxygenated foam, while urea shares antiseptic and antimicrobial abilities as well and can enhance the pH of the oral cavity. These substances have been used in wound healing either in skin or intraorally, as well as in oral hygiene for a long time. However, to date, no clinical trial examining the use of a hydrogen carbamide/peroxide product in oral wound healing, postoperative symptoms or dry mouth has been reported. Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results.

Conditions

• Wound Heal
• Oral Dryness
• Postoperative Pain
• Sjogren's Syndrome
• Biopsy Wound
• Mouth; Wound
• Mouth Dryness
• Dental Plaque
• Gingival Inflammation

Interventions

Type	Name	Description
DEVICE	Carbamide Peroxide Mouthwash	The experinmental mouthwah is a solution containing 4.3% w/v hydrogen carbamide, which breaks down to 1.51% w/v hydrogen peroxide, serving as the active ingredient. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine. It is a Class IIa, CE-marked medical device made and distributed by Intermed S.A. and Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
DEVICE	Placebo mouthwash	Placebo mouthwash is a similar (look-and-taste-alike) solution to the experinmental mouthwash made by the same manufacturer, without active ingredients. Participants rinse (swish and spit) with the mouthwash three times a day for one minute each time, using a 10ml quantity (as indicated by a marking line inside the bottle cap) for a total of 14 days, starting from day 0, i.e. the day of the biopsy (see procedure in the detailed description). Consumption of liquid or solid foods should be avoided for at least thirty minutes following each rinse. Participants are asked to maintain their usual oral hygiene routine.

Timeline

• Start date: 2023-04-25
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-04-12
• Last updated: 2024-07-03

Locations

1 site across 1 country: Greece