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临床试验/CTRI/2025/04/084903
CTRI/2025/04/084903尚未招募1 期

Comparative Evaluation Of The Effect Of Antioxidant Therapy On Oxidative Stress Produced In Patients Undergoing Fixed Appliance Therapy-A Randomized Control Trial

Dr Mayuri Suhas Desai1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年6月2日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
To evaluate and compare the impact of antioxidant supplements on oxidative stress levels in patients undergoing fixed orthodontic therapy, using salivary biomarkers

研究概览

简要总结

Orthodontic treatment uses fixed appliances to promote oral health and correct malocclusions. Several inflammatory mediators are released in response to the mechanical forces applied during treatment. The ensuing inflammation in the oral cavity leads to oxidative stress, which is defined as the imbalance between the production of free radicals and the body’s ability to arrest or minimize their harmful effects through neutralization by anti-oxidants. It is a pathologic asymptomatic event, highly detrimental to tissues, and in recent years, has been considered as a trigger event for several human diseases.

Oxidative damage is caused mainly by the release of free radicals generated by exposure to UV rays, X rays and can also be produced by leukocytes and macrophages during the inflammatory process. From a biological and pathological point of view, the most important free radicals are the reactive oxidative species(ROS) and the important ones to be considered are the superoxide anion (O2), hydrogen peroxide(H2O2), hydroxyl radical(OH), and hypochloric acid(HOCl).

Phospholipid membranes are primarily the biological targets of oxidative stress. The most abundant cellular component, proteins, are also significant targets for free radicals; even minor changes to one protein can have a significant impact on the biological activity and functionality of cells.

Oxidative stress (O.S.) has been implicated to be the causative factor of numerous pathological illnesses, such as rheumatoid arthritis, neurological diseases, atherosclerosis, inflammatory diseases, chronic renal failure, and even diabetes. Intraorally, it is involved in the development of enamel surface alteration, caries, squamous cell carcinoma and periodontitis. Osteoblastic and osteoclastic cells involved in the bone remodeling process are also particularly sensitive to oxidative damage.

Saliva is a vital component of the oral cavity and can be considered as the first barrier to oxidative stress due to its antioxidant capacity. It helps to maintain oral health, contributes to the body’s oral defense, and the balance of the oral environment. Saliva has gained popularity as a diagnostic tool in clinical studies in recent years, due to its accessibility, ease of collection, and the possibility of taking repeated, non-invasive samples for screening, diagnosing, and researching a variety of illnesses. Therefore, oxidative status assessment in the oral cavity has been proposed as a key diagnostic and progression assessment method for these disorders.

Over the past few years, several studies have provided evidence of O.S. associated with orthodontic treatment which may have significant clinical implications with serious consequences for long-term oral health.Antioxidant supplements have been proposed to be effective in containing the oxidative stress produced however there is no published literature available on the same. This trial was therefore taken up to assess and compare the effect of antioxidant supplementation on the oxidative stress produced by fixed orthodontic treatment.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Patients with good general and oral health.
  • Patients with no prior orthodontic treatment in last 24 months.

排除标准

  • Smokers or tobacco users.
  • Patients with active periodontal disease at the time of enrollment.
  • Patients with systemic diseases such as diabetes, autoimmune diseases, or chronic inflammatory conditions.
  • Patients taking antioxidant supplements, multivitamins, or medications that could affect oxidative stress levels within the past 6 weeks.
  • Patients undergoing concurrent dental treatments that may influence salivary biomarkers (e.g., periodontal therapy, restorative treatments).

结局指标

主要结局

To evaluate and compare the impact of antioxidant supplements on oxidative stress levels in patients undergoing fixed orthodontic therapy, using salivary biomarkers

时间窗: T1: Before starting the fixed orthodontic therapy. | T2: One-month follow-up. | T3: Three-month follow-up.

次要结局

  • To determine the temporal changes in oxidative stress levels (at baseline, 1 month, and 3 months) in patients undergoing fixed orthodontic therapy(T1: Before starting the fixed orthodontic therapy.)
  • 1. To assess the oxidative stress generated in patients undergoing fixed orthodontic treatment.(T1: Before starting the fixed orthodontic therapy.)
  • 3. To compare the levels of oxidative stress in patients receiving fixed orthodontic therapy with and without antioxidant supplementation.(T1: Before starting the fixed orthodontic therapy.)

研究者

发起方
Dr Mayuri Suhas Desai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mayuri Suhas Desai

Manipal College of Dental Sciences, Mangalore

研究点 (1)

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