Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Biomarkers of Orthodontic Root Resorption
研究概览
简要总结
The majority of previous studies for early detection of Orthodontically Induced Inflammatory Root Resorption (OIIRR) were conducted to assess individual biomarkers which are representative of single biological pathway. To our Knowledge, no studies have been employed Gingival crevicular fluid (GCF) proteomic analysis to identify potential biomarkers for OIIRR. Therefore; the aim of this study is to use the advantage of testing a package of biomarkers via doing proteomic analysis of GCF which could help in making a more precise personalize diagnosis and treatments, thereby providing orthodontists additional information that cannot be deduced from clinical parameters.
详细描述
Orthodontic patients with age range (18-years) indicated for bilateral maxillary first premolars extraction as part of their orthodontic treatment using specific fixed orthodontic appliance design with moderate anchorage were recruited for this study. Both of these premolars were allocated randomly to a heavy ( 225g) and light (25g) force in a split mouth design with a 1:1 allocation ratio. (GCF) was collected from the gingival sulcus of these teeth before extraction at six time intervals which are baseline, 1 hour, 1 day, 1 week , 2 weeks, 3 weeks and 4 weeks. Plaque and Gingival Indices were recorded for those patients at each timeline. Premolars will be extracted after 4weeks to be examined by stereomicroscopy for surface area evaluation of root resorption. Proteomic analysis will be carried out on the GCF sample. The proteomic analysis of the collected GCF will be obtained by using matrix-assisted laser desorption ionization/ time-of-flight mass spectrometry (MALDI-TOF/MS). MS spectra will be used to search human protein sequence data bases for protein identification and the development of "Protein Print" specific for these biological conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The GCF measures were coded by a clinician who bonded the appliance using patient ID number and the side of the arch (either right or left sides) to which orthodontic force (either heavy or light force) was allocated blindly for the investigator and outcomes assessor because the clinician could know the type of force from the shape of archwires. The surgeon who extract the teeth was also blinded. The extracted premolars were coded to be masked to the investigator who measured the root resorption areas. All outcome assessors of proteomic analysis as well as the statistician was blinded.
入排标准
- 年龄范围
- 18 Years 至 32 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic patients indicated for extraction of bilateral upper first premolars,
- •General healthy fit,
- •Good oral hygiene with periodontal health maintenance (Plaque Index and Gingival Index ≤1),
- •Lack of radiographic signs of idiopathic resorption,
- •Radiographically both experimental teeth have two roots with approximately equal length and shape,
- •The position of experimental teeth within the arch with no rotation.
排除标准
- •Patients with impaction except impacted third molars for referral to do CBCT,
- •Patients on anti-inflammatory drugs at least three months before and during the study,
- •History of oral habit,
- •Previous orthodontic treatment,
- •History of dental trauma,
- •Previous dental treatment of the experimental teeth,
- •Patient with heavy occlusion,
- •Pathological lesion in the upper arch.
结局指标
主要结局
Biomarkers of Orthodontic Root Resorption
时间窗: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
To monitor change in profiling of GCF proteins associated with orthodontically induced root resorption during 4 weeks after orthodontic force application
次要结局
- GCF Flow Rate and Orthodontic Force(Baseline, 1hour, 1day, 7days, 14days, 21days and 28days)
- Root Resorption Surface Area(After 28 days of force application.)
- Protein concentration in Orthodontic GCF(Baseline, 1hour, 1day, 7days, 14days, 21days and 28days)
研究者
Harraa S. Mohammed-Salih
PhD student
University of Baghdad