Assessing the Efficacy of a Hydrogen Peroxide Gel for Oral Wound Healing and Oral Hygiene

NCT06370260 | Completed DMC

• 2 other identifiers: INTM-PMCF-UNIGEL571/13.02.2023
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Assessment of wound healing based on Percentage Healing Index on day 14

  The Percentage Healing Index (PHI) is calculated based on three distinct values: the wound area at T0 and T2.These values are acquired through standardized pictures taken immediately after biopsy (T0) and 14 days post-biopsy (T2), with the aid of a UNC 15 (North Carolina) periodontal probe, acting as a calibrator, that was placed alongside the treated area.The images obtained are processed using software (Image J, developed by Wayne Rasband and contributors at the National Institutes of Health, USA), capable of calculating the area in square millimeters (mm). Initially, the T2 area is divided by the T0 area, and the result is multiplied by 100. The resulting value, known as the percentage unhealed index (PUI), indicates the percentage of the lesion that remained unhealed. The complementary value to this percentage is defined as the PHI at T2. Comparisons will be made between the UNISEPT® ORAL GEL versus the placebo group.

  Day 14

• Assessment of wound healing based on Percentage Healing Index on day 7

  The Percentage Healing Index (PHI) is calculated based on three distinct values: the wound area at T0 and T1.These values are acquired through digital photographs taken immediately after biopsy (T0) and at 7 days post-biopsy (T1), with the aid of a periodontal probe, acting as a calibrator, that was placed alongside the treated area.The images obtained are processed using software (Image J, developed by Wayne Rasband and contributors at the National Institutes of Health, USA), capable of calculating the area in square millimeters. Initially, the T1 area is divided by the T0 area, and the result is multiplied by 100.The resulting value, known as the percentage unhealed index (PUI), indicates the percentage of the lesion that remained unhealed. The complementary value to this percentage is defined as the PHI at T1. Comparisons will be made between the UNISEPT® ORAL GEL versus the placebo group.

  Day 7

Secondary Outcomes (7)

• Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home)

  Days 0,1,2,3,4,5 and 6

• Postoperative symptoms (pain, eating and speech difficulty) on day 7

  Day 7

• Postoperative symptoms (pain, eating and speech difficulty) on day 14

  Day 14

• Wound healing based on clinical signs

  Days 7 and 14

• Oral Hygiene - Dental Plaque: Sextant Plaque Index

  Days 0,7 and 14

Other Outcomes (3)

• Adverse Events

  Day 0,7 and 14

• Participant's comments and satisfaction regarding the provided treatment/use of the products

  Day 14

• Compliance

  Day 14

Study Arms (2)

UNISEPT® ORAL GEL

EXPERIMENTAL

A gel containing hydrogen carbamide/peroxide as active ingredient

Device: Hydrogen Carbamide/Peroxide Gel

PLACEBO

PLACEBO COMPARATOR

A gel that looks and tastes like UNISEPT® ORAL GEL without active ingredients

Device: Placebo Gel

Interventions

Hydrogen Carbamide/Peroxide Gel DEVICE

UNISEPT® ORAL GEL is an oral gel containing 10% w/v urea peroxide which releases 3.50% w/w hydrogen peroxide, glycerin, propylene glycol, carbopol, disodium EDTA, sodium saccharin, methyl salicylate, menthol, and water, serving as the active ingredient. Participants should apply the gel to the biopsy area and the corresponding sextant teeth three times daily, leaving it on for five minutes without rinsing, for a total of 14 days, beginning on 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 gel application.Participants are asked to maintain their usual oral hygiene routine. UNISEPT® ORAL GEL is a Class IIa, CE-marked medical device made and distributed by Intermed S.A. and Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.

Also known as: UNISEPT® ORAL GEL

UNISEPT® ORAL GEL

Placebo Gel DEVICE

Placebo gel is a similar (look-and-taste-alike) product to UNISEPT® ORAL GEL, made by the same manufacturer, without active ingredients, containing glycerin, propylene glycol, carbomer, menthol, sodium saccharin, methyl salicylate, triethanolamine. Participants are called upon to apply the gel in exactly the same way as the experimental product, i.e apply the gel to the biopsy area and the corresponding sextant teeth three times daily, leaving it on for five minutes without rinsing, for a total of 14 days, beginning on day 0.

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients requiring incisional or excisional biopsy in the gingiva or palate
• 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

You may not qualify if:

• Age \<18 years
• Total number of teeth in the selected sextant \<2
• Existence of orthodontic appliances
• Presence or history of oral malignant lesions
• Existence of viral or other infections of the oral cavity, that could interfere with the primary outcomes of the study
• Currently undergoing and/or has received radiation therapy to the head or neck
• Currently receiving or has received within the previous 12 months chemotherapy and/or targeted therapies for any malignancy
• History of acute myocardial infarction and/or vascular stroke during the last 6 months
• 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
• 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
• Malnutrition
• Alcohol abuse and (illicit) drug use disorders
• Pregnancy or lactation/nursing/breast feeding

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead
• Ioulia And Irene Tseti Pharmaceutical Laboratories S.A.: collaborator

Study Sites (1)

Department of Oral Medicine & Pathology and Hospital Dentistry, School of Dentistry

Athens, Attica, 11527, Greece

Location

Related Publications (8)

• Marshall MV, Cancro LP, Fischman SL. Hydrogen peroxide: a review of its use in dentistry. J Periodontol. 1995 Sep;66(9):786-96. doi: 10.1902/jop.1995.66.9.786.

  PMID: 7500245 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• Papagiannopoulou V, Oulis CJ, Papaioannou W, Antonogeorgos G, Yfantopoulos J. Validation of a Greek version of the oral health impact profile (OHIP-14) for use among adults. Health Qual Life Outcomes. 2012 Jan 14;10:7. doi: 10.1186/1477-7525-10-7.

  PMID: 22244162 BACKGROUND

• Wennstrom J, Lindhe J. Effect of hydrogen peroxide on developing plaque and gingivitis in man. J Clin Periodontol. 1979 Apr;6(2):115-30. doi: 10.1111/j.1600-051x.1979.tb02190.x.

  PMID: 379049 BACKGROUND

• Muniz FWMG, Cavagni J, Langa GPJ, Stewart B, Malheiros Z, Rosing CK. A Systematic Review of the Effect of Oral Rinsing with H2O2 on Clinical and Microbiological Parameters Related to Plaque, Gingivitis, and Microbes. Int J Dent. 2020 Oct 31;2020:8841722. doi: 10.1155/2020/8841722. eCollection 2020.

  PMID: 33178277 BACKGROUND

• Palaia G, Tenore G, Tribolati L, Russo C, Gaimari G, Del Vecchio A, Romeo U. Evaluation of wound healing and postoperative pain after oral mucosa laser biopsy with the aid of compound with chlorhexidine and sodium hyaluronate: a randomized double blind clinical trial. Clin Oral Investig. 2019 Aug;23(8):3141-3151. doi: 10.1007/s00784-018-2735-0. Epub 2018 Oct 30.

  PMID: 30374831 BACKGROUND

• Lopez-Jornet P, Camacho-Alonso F, Martinez-Canovas A. Clinical evaluation of polyvinylpyrrolidone sodium hyaluronate gel and 0.2% chlorhexidine gel for pain after oral mucosa biopsy: a preliminary study. J Oral Maxillofac Surg. 2010 Sep;68(9):2159-63. doi: 10.1016/j.joms.2009.09.047. Epub 2010 Jun 11.

  PMID: 20538398 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Wounds and Injuries; Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Nikolaos Nikitakis, DDS,MD,PHD

  School of Dentistry, National and Kapodistrian University of Athens

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR AND CHAIR, DEPT. OF ORAL MEDICINE & PATHOLOGY AND HOSPITAL DENTISTRY, UNIVERSITY OF ATHENS, GREECE

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2024
• First Posted: April 17, 2024
• Study Start: May 2, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests will be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered.
• Access Criteria: Access to trial individual participant data (IPD) can be requested by qualified investigators whose proposed research has received Institutional Review Board (IRB) approval. Data will be available via a data repository following execution of data use agreement.

Locations

GR (1)