Clinical trial NCT06370260: Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene
Official title: A Randomized Placebo-Controlled Clinical Trial Assessing the Efficacy of a Hydrogen Peroxide Gel (UNISEPT®ORAL GEL) for Oral Wound Healing, Postoperative Symptoms and Oral Hygiene in Patients Undergoing Incisional or Excisional Punch Biopsy of Gingival or Palatal Oral Mucosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Postoperative Pain
Biopsy Wound
Wound; Mouth
Quality of Life
Dental Plaque
Gingival Inflammation
Keywords: oral gel
oral wound healing
oral biopsy
gingiva
palate
postoperative pain
hydrogen carbamide
hydrogen peroxide
oral hygiene
plaque index
gingival index
secondary intention healing
quality of life
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
Collaborators: name: Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.
First posted: 2024-04-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is designed as a prospective, randomized, placebo-controlled, triple blinded, with two parallel groups and an equal allocation ratio in all groups. In this study, the intervention consists of delivery of a hydrogen carbamide/peroxide gel or placebo gel, made by the same manufacturer.
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effectiveness and safety of a hydrogen carbamide/peroxide gel, called UNISEPT® ORAL GEL, in promoting oral wound healing, alleviating postoperative symptoms, and enhancing oral hygiene.

Study participants will include individuals with any suspicious lesion in their gums or the roof of their mouth. They will undergo a procedure to remove a small piece of tissue for testing (biopsy) in order to confirm the diagnosis.This is a standardized diagnostic procedure that involves the use of a punch, which is a plastic handpiece with a cylindrical cutting blade. Subsequently, the wound heals naturally without the need for sutures.

Researchers are comparing this gel 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 oral hygiene. Participants randomly get the hydrogen carbamide/peroxide gel or the placebo one to use for 14 days after the biopsy. The researchers will not know which one they are providing as the gel tubes will be identical.

Oral wound healing, postoperative symptoms (such as pain, eating and speech difficulties), oral hygiene (dental plaque and gingival inflammation) 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 biopsy, one at 7 days and one at 14 days after the biopsy. They are asked to fill in some questionnaires, while certain procedures (taking a photo the site of the biopsy) 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, women or men, with any lesion in the gingiva or the palate (potentially malignant disorders, pigmented lesions, soft tissue masses) that require an incisional or excisional biopsy, following histopathological examination, can be enrolled, after checking if they comply with the study's criteria. Then, they are informed about the study and the biopsy procedure and they sign the Ιnformed Consent Form.

All biopsies are obtained from the gingiva or hard palate with a sterile disposable or reusable punch of 4,6 or 8mm in diameter, resulting in the extraction of similar tissue cylinders.The punch is grasped between the index and thumb, supporting the cylinder over the target lesion. Healing by secondary intention follows, as suturing of the residual wound is not necessary, and the bleeding can be contained by simply applying a piece of gauze.

Participants are instructed to have cold and soft diet for the day. 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 hydrogen carbamide/peroxide gel (UNISEPT® ORAL GEL - Intermed S.A. and Ioulia And Irene Tseti Pharmaceutical Laboratories S.A) or a placebo comparator, i.e. a look-alike substance that lacks active ingredients (such as hydrogen carbamide/peroxide). Both participants and investigators are masked. Follow-up examinations are conducted at 7 and 14 days.

The evaluation includes:

oral wound healing (secondary intention) assessed by percentage healing index (PHI)(primary outcome)

and secondary outcomes: oral wound healing assessed by clinical parameters (such as redness, oidema, pus discharge) postoperative symptoms (such as pain, eating and speech difficulties) quality of life assessed by a questionnaire oral hygiene via plaque and gingival indices.

All data are anonymized and the outcome assessors are masked.

UNISEPT® ORAL GEL is a Class IIa, CE-marked (Conformité Européenne) medical device. This gel contains hydrogen carbamide that breaks down to hydrogen peroxide, which has antiseptic and antimicrobial properties. 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, there is no clinical trial examining the use of a hydrogen carbamide/peroxide product in oral wound healing and postoperative symptoms. Published clinical studies on the control of dental plaque and periodontal inflammation exhibit partially conflicting results.

Eligibility criteria: Inclusion Criteria:

1. Age \>18 years
2. Patients requiring incisional or excisional biopsy in the gingiva or palate
3. 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

Exclusion Criteria:

1. Age \<18 years
2. Total number of teeth in the selected sextant \<2
3. Existence of orthodontic appliances
4. Presence or history of oral malignant lesions
5. Existence of viral or other infections of the oral cavity, that could interfere with the primary outcomes of the study
6. Currently undergoing and/or has received radiation therapy to the head or neck
7. Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy
8. History of acute myocardial infarction and/or vascular stroke during the last 6 months
9. 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
10. Use of antibiotics in the last 1 month prior to biopsy or conditions requiring antibiotic prophylaxis
11. Use of any antimicrobial mouthwash in the last 1 month before the biopsy
12. 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
13. Malnutrition
14. Alcohol abuse and (illicit) drug use disorders
15. Pregnancy or lactation/nursing/breast feeding
16. Known allergy to any of the ingredients of the study products
17. Inability to provide informed consent
18. Participation in another study of an investigational product or device until the primary endpoint is met
19. 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

Primary outcomes:
measure: Assessment of wound healing based on Percentage Healing Index on day 14
timeFrame: Day 14
measure: Assessment of wound healing based on Percentage Healing Index on day 7
timeFrame: Day 7
Secondary outcomes:
measure: Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home)
timeFrame: Days 0,1,2,3,4,5 and 6
measure: Postoperative symptoms (pain, eating and speech difficulty) on day 7
timeFrame: Day 7
measure: Postoperative symptoms (pain, eating and speech difficulty) on day 14
timeFrame: Day 14
measure: Wound healing based on clinical signs
timeFrame: Days 7 and 14
measure: Oral Hygiene - Dental Plaque: Sextant Plaque Index
timeFrame: Days 0,7 and 14
measure: Oral Hygiene - Gingival Inflammation: Sextant Gingival Index
timeFrame: Days 0,7 and 14
measure: Oral Health Related Quality of Life
timeFrame: Day 14
Other outcomes:
measure: Adverse Events
timeFrame: Day 0,7 and 14
measure: Participant's comments and satisfaction regarding the provided treatment/use of the products
timeFrame: Day 14
measure: Compliance
timeFrame: Day 14
Locations:
city: Athens
country: Greece
facility: Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry
state: Attiki
Study officials:
affiliation: School of Dentistry, National and Kapodistrian University of Athens
name: Nikolaos Nikitakis, DDS,MD,PHD
role: STUDY_CHAIR
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