Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Clinical Assessment of OLP lesions using OLP score
研究概览
简要总结
The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life:
The research question aims to answer:
Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life?
Participants will:
Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler
详细描述
The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.
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)
盲法说明
This was a double-blind, parallel-group clinical trial. Both participants and outcome assessors were blinded to the intervention. The honey in orabase and triamcinolone formulations were prepared to appear similar in color, texture, and packaging to ensure concealment. Identical containers were used for both treatments, and labeling was done using coded identifiers maintained by a third party not involved in the assessment or data analysis. Participants were instructed to apply the provided formulation as directed without being informed of the specific treatment assignment.
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of oral lichen planus
- •Symptomatic OLP lesions (erosive/atrophic)
- •Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.
排除标准
- •Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
- •Patients who administer systemic corticosteroids or immunosuppressive agents.
- •Pregnancy or lactation
- •Inability to comprehend or adhere to study directives
- •Patients who are not able to sign an informed written consent
研究组 & 干预措施
Group I with OLP at buccal mucosa
The trial Group (I) (honey in orabase 1: 1 paste), four times daily after meals or rinsing
干预措施: Honey in orabase 1: 1 paste (Drug)
Group II with OLP at buccal mucosa
Group (II): triamcinolone acetonide 0.1% ointment, four times daily after meals or rinsing
干预措施: Honey in orabase 1: 1 paste (Drug)
结局指标
主要结局
Clinical Assessment of OLP lesions using OLP score
时间窗: baseline to 1 year
will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area \< 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area \< 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface.
Pain assessment using Visual analogue scale (VAS)
时间窗: baseline- to 1 year
(VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters)
次要结局
- Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment(baseline to 1 year)
研究者
Sally Abd-ElMeniem ElHaddad
Assist. Prof. Oral Medicine and Periodontology
Dar Al Uloom University