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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Assessment of wound healing based on the modified Landry Healing Index on day 14
研究概览
简要总结
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.
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 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)
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 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.
排除标准
- •Age <18 years
- •Total number of teeth in the oral cavity <10
- •Existence of orthodontic appliances
- •Current use of bleaching trays
- •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)
- •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
- •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
- •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
- •Received dental treatment during the period included in the study
- •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
研究组 & 干预措施
Carbamide Peroxide Mouthwash
A mouthwash containing carbamide proxide/hydrogen peroxide as active ingredient
干预措施: Carbamide Peroxide Mouthwash (Device)
Placebo
A mouthwash that looks, smells and tastes like the experinmental mouthwash without active ingredients
干预措施: Placebo mouthwash (Device)
结局指标
主要结局
Assessment of wound healing based on the modified Landry Healing Index on day 14
时间窗: Day 14
Healing will be measured clinically using specific scores. The modified Landry Healing Index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). As the initial index referred to gingival healing, it was slightly modified as in other studies, so that it refers to oral mucosal healing. The index values range from 1 to 5, where 1 corresponds to "very poor healing" and 5 to "excellent healing". Comparisons will be made between the carbamide peroxide mouthwash versus the placebo group.
Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 14
时间窗: Day 14
Healing will be measured clinically using specific scores. The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3, 4 or 6 points are used to evaluate CSR (modified by adding point 4), whereas 0, 1, or 2 points are used for CSH and CSI. The EHS is generated by the summation of the points of these 3 parameters. The EHS for ideal wound healing is 10 points, while the worst possible score is 0 points. Comparisons will be made between the carbamide peroxide mouthwash versus the placebo group.
Assessment of wound healing based on the modified Landry Healing Index on day 7
时间窗: Day 7
Healing will be measured clinically using specific scores. The modified Landry Healing Index consists of the assessment of 5 clinical parameters (tissue color, bleeding on palpation, presence of granulation tissue, presence of suppuration, and healing of the surgical margin). As the initial index referred to gingival healing, it was slightly modified as in other studies, so that it refers to oral mucosal healing. The index values range from 1 to 5, where 1 corresponds to "very poor healing" and 5 to "excellent healing". Comparisons will be made between the carbamide peroxide mouthwash versus the placebo group.
Assessment of wound healing based on a modified version of the Early Wound Healing Score (EHS) on day 7
时间窗: Day 7
Healing will be measured clinically using specific scores. The EHS is composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of haemostasis (CSH), and clinical signs of inflammation (CSI). Zero, 3, 4 or 6 points are used to evaluate CSR (modified by adding point 4), whereas 0, 1, or 2 points are used for CSH and CSI. The EHS is generated by the summation of the points of these 3 parameters. The EHS for ideal wound healing is 10 points, while the worst possible score is 0 points. Comparisons will be made between the carbamide peroxide mouthwash versus the placebo group.
次要结局
- Postoperative symptoms (pain, eating and speech difficulty) on day 14(Day 14)
- Wound healing based on the incision/wound length(Days 0, 7 and 14)
- Postoperative symptoms (pain, eating and speech difficulty) during the first week (at home)(Days 0, 1, 2, 3, 4, 5 and 6)
- Observed (objective) signs of oral dryness(Days 0, 7 and 14)
- Postoperative symptoms (pain, eating and speech difficulty) on day 7(Day 7)
- Subjective oral dryness symptoms (8-item VAS questionnaire)(Days 0, 7 and 14)
- Oral Hygiene - Dental Plaque: Full-Mouth Plaque Index(Days 0, 7 and 14)
- Change in Unstimulated Saliva Flow Rate(Days 0 and 14)
- Oral Hygiene - Gingival Inflammation: Full Mouth Gingival Index(Days 0, 7 and 14)
- Assessment of swelling in the biopsy area(Day 7 and 14)
- Oral Health Related Quality of Life(Day 14)
研究者
Nikolaos Nikitakis
Professor and Chair, Department of Oral Medicine and Pathology and Hospital Dentistry, School of Dentistry and Dean, School of Dentistry
National and Kapodistrian University of Athens