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临床试验/CTRI/2024/12/078494
CTRI/2024/12/078494尚未招募不适用

To compare the impact of Low-Level Laser Therapy on Gingival Crevicular Fluid Alkaline Phosphatase and Aspartate Aminotransferase following placement of Elastomeric and Kesling separators with pain perception in an adult population: A Split-Mouth Randomized Control Trial Study

Dr Sejul Jaiswal1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年12月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
To evaluate the association of the effect of Low-Level Laser Therapy on GCF biomarkers after placement of Kesling and Elastomeric separators along with pain perception.

研究概览

简要总结

Introduction - Posterior teeth endure higher masticatory forces than anterior teeth, making bands preferable to bonding in the posterior region. The average periodontal ligament (PDL) spacing is 0.25 mm. A 0.16 mm thick metal band without sufficient tooth separation can cause alveolar bone contraction, PDL hyalinization, and discomfort. Proper separation minimizes discomfort, protects tooth structure and soft tissue, and reduces patient strain. Effective separators should be radiopaque, easy to clean and install, and secure. Elastomeric separators, which are small and elastic, create space between adjacent teeth by placing rings of various thicknesses around the interproximal contact point. They come in two types: rounded and angular, and the separation process takes about seven days using pliers. Patients find elastic ring separators most comfortable. Kesling metallic ring separator springs, made from 0.016-inch Australian wire, consist of gingival, occlusal, and retentive arms, and a coil/helix. They create space for bands in about two days and come in four sizes based on arm length. Kesling separators are patient-friendly and faster than other types. Studies show discomfort peaks 24 hours after placement. Periodontal pain arises from pressure, ischemia, inflammation, and edema. Gingival crevicular fluid (GCF) is useful for identifying biomarkers, containing materials from oral bacteria, periodontium cells, host inflammatory cells, and serum. It is a non-invasive method for studying periodontal tissue issues. Low-Level Laser Therapy (LLLT), or photobiomodulation, reduces pain, chemical mediators, cytokines, and inflammation while promoting early wound healing. A randomized controlled trial aims to provide evidence on LLLT’s effectiveness in reducing inflammation and pain from separator placement, guiding its use as a non-invasive, cost-effective method for managing orthodontic pain.

Objective - To evaluate the effect on GCF biomarkers with and without the use of Low-Level Laser Therapy after placement of Kesling and elastomeric separators.

Methodology - This study will include 10 patients aged 18-27 requiring orthodontic treatment with separators. - Each patient will have a study and control site (left and right quadrants) for low-level laser therapy. - Informed consent will be obtained, with a thorough explanation and the option to drop out. - GCF samples will be collected before separator placement to find baseline biomarker values. - Kesling separators will be placed on the mesial and distal sides of the 1st molar in the maxillary arch, and elastomeric separators in the mandibular arch. - Low-level laser therapy will be applied to the test side, while the control side remains untreated. - The diode laser (GaAlAs) will operate at 810 nm, with 2 J/cm² energy density, and 200 mW power output for 20 seconds. - GCF will be collected from both sides at four time points: before separator placement, and 24, 48, and 72 hours after placement. - GCF samples will be collected from the mesial side of all four 1st molars, buccally and palatally, using a micropipette. - Samples will be transported in an airtight sterile container on ice to the biochemistry lab. - GCF will be biochemically assessed for Alkaline Phosphatase and AST.

Evaluation - The study will be conducted over 4 visits. First Visit: - Divide each patient’s oral cavity into four quadrants. - Place Kesling separators on the upper arch and elastomeric separators on the lower arch. - Administer LLLT to one side of the oral cavity. - Collect GCF samples from all four quadrants. Subsequent Visits: - Repeat the same procedure at each visit.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 27.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients in the age group of 18-27 years.
  • 2.Systemically healthy patients.
  • 3.Patients with healthy periodontium with generalized probing depth of 3 mm and no radiographic bone loss.
  • 4.Bilaterally symmetric arch (Presence of teeth on both sides of the arch).

排除标准

  • Patients on NSAIDs or opioids within a month before the study.
  • Patients on antibiotics during last 6 months
  • Removal or loss of the separator during the experiment.
  • Patients with poor oral hygienes and periodontal diseases.
  • Patients with systemic illnesses, oral lesions or pathologies.

结局指标

主要结局

To evaluate the association of the effect of Low-Level Laser Therapy on GCF biomarkers after placement of Kesling and Elastomeric separators along with pain perception.

时间窗: The study will be conducted in 4 visits and the level of Gingival Crevicular Fluid markers will be assessed at baseline, 24 hours, 48 hours and 72 hours.

次要结局

  • To compare the association of the effect of Low-Level Laser Therapy on GCF biomarkers after placement of Kesling & Elastomeric separators along with pain perception.(The study will be conducted in 4 visits.)

研究者

发起方
Dr Sejul Jaiswal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sejul Jaiswal

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur

研究点 (1)

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