Evaluation of the Efficacy of Ozonated Olive Oil and Low-Level Laser Therapy in the Treatment of Pain in Individuals With Temporomandibular Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Pain Evaluation
研究概览
简要总结
The aim of the present study was to determine the efficacy of ozonated olive oil and low-level laser therapy (LLLT) in treating pain in individuals with TMD. In this prospective, randomized, split-mouth, double-blind study, two different treatment methods were applied to the patients.
详细描述
two different treatment methods were applied to the patients. Group 1 (study group, one side of the same patient): topical ozonated olive oil + LLLT; Group 2 (the other side of the same patient): Olive oil with topical ozone + LLLT (not activated). The ozonated olive oil was applied topically three times a day for four weeks, the LLLT was applied noncontact at a distance of 1 cm, and patients attended three sessions per week for four weeks. Before starting treatment, and after 6 sessions of laser therapy, the patients were evaluated. (2 weeks), after 12 laser sessions (1 month), and 3 months after the first session.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In order to apply the principle of double-blind, we ensure that neither the laser therapist nor the patient knew whether the treatment was active or not, classical music was played in the background to mask the laser sound and the laser's programs were arranged by an assistant so that the treatment did not begin until a permission was taken from the assistant; in addition, labels on Oil bottles were removed by an assistant to ensure that no one knew the type of the Oil or its ingredients. For safety reasons, both the patient and the laser therapist wore protective goggles during the laser treatment. All patients were treated with ozonated olive oil and LLL by the same therapist.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals aged 18 and over,
- •Individuals should be literate so that they can evaluate the consent form themselves,
- •Individuals with no restrictions to the use of any medication to be prescribed during the study,
- •Individuals who have not been treated for temporomandibular joint disease in the past 3 months,
- •Individuals who have not used any medication for the past two weeks,
- •Individuals who will participate in the study must be residing in the province of Van so that their regular records can be obtained,
- •Individuals without systemic disease,
- •Individuals with chronic pain, (pain that has been ongoing and lasted longer than six months),
- •Individuals with bilateral pain complaints,
- •Individuals without missing teeth,
- •Individuals without open bite and/or crossbite,
排除标准
- •Individuals with internal disorders and/or inflammatory joint disorders and/or joint's sound, 25
- •Individuals who have undergone interventional or surgical procedures on the Temporomandibular joint,
- •Individuals with temporomandibular joint pathology,
- •Individuals with the possibility of either being pregnant, are pregnant or lactating,
- •Individuals who will not attend postoperative check-ups,
- •Individuals using drugs other than those recommended,
- •Individuals who are allergic to any of the drugs and materials to be used throughout the study,
- •Individuals with contraindications to Ozone or Laser therapy.
研究组 & 干预措施
Ozonated olive oil
(0.03PPM ozone + 6-6.5 PH olive oil, viscosity at 25°C 55mPas, relative density gr/ml (20°C) 0.98 pycnometer, Ozonated olive oil, 100 ml bottle, Olive Farm, GÜLLERDAĞI TURİZM TARIM İNŞ), Ozonated Olive Oil is used 3 times a day, every day for four weeks. Patients were instructed to spray three times on each side. To ensure commitment, Oil canisters were marked in the middle, which the patient was required to use until the label in the first two weeks, and the remaining amount in the second two weeks.
干预措施: Ozonized Olive Oil Solutions (Drug)
Ozonated olive oil with low level laser therapy
(810 nm diode laser, 3.4 j/cm2 energy density, 0.5w power, CHEESE DEN7A/DEN4A 810, 2 min for each side) was applied non-contact at a distance of 1 cm, the most painful points in the muscles diagnosed during the first examination were irradiated with circular movements and patients were called for 3 sessions per week over four weeks.
干预措施: Ozonized Olive Oil Solutions (Drug)
Ozonated olive oil with low level laser therapy
(810 nm diode laser, 3.4 j/cm2 energy density, 0.5w power, CHEESE DEN7A/DEN4A 810, 2 min for each side) was applied non-contact at a distance of 1 cm, the most painful points in the muscles diagnosed during the first examination were irradiated with circular movements and patients were called for 3 sessions per week over four weeks.
干预措施: Low Level Laser LLL Therapy (Device)
结局指标
主要结局
Pain Evaluation
时间窗: Post-treatment (after 3 months)
Patients will be requested to mark their pain intensity on a pain assessment form using a visual analog scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
次要结局
未报告次要终点
研究者
levent Cigerim
Head of oral and maxillofacial department
Yuzuncu Yıl University