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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Assessment of wound healing based on Percentage Healing Index on day 14
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Known allergy to any of the ingredients of the study products
- •Inability to provide informed consent
- •Participation in another study of an investigational product or device until the primary endpoint is met
- •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
结局指标
主要结局
Assessment of wound healing based on Percentage Healing Index on day 14
时间窗: 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.
Assessment of wound healing based on Percentage Healing Index on day 7
时间窗: 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.
次要结局
- 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)
- Oral Hygiene - Dental Plaque: Sextant Plaque Index(Days 0,7 and 14)
- Oral Hygiene - Gingival Inflammation: Sextant Gingival Index(Days 0,7 and 14)
- Wound healing based on clinical signs(Days 7 and 14)
- Postoperative symptoms (pain, eating and speech difficulty) on day 14(Day 14)
- Oral Health Related Quality of Life(Day 14)
研究者
Nikolaos Nikitakis
PROFESSOR AND CHAIR, DEPT. OF ORAL MEDICINE & PATHOLOGY AND HOSPITAL DENTISTRY, UNIVERSITY OF ATHENS, GREECE
National and Kapodistrian University of Athens