Proteomics and Orthodontic Root Resorption

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial

Conditions
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Root Resorption, Orthodontic Appliance Complication, Orthodontic Pathological Resorption of External Root, Gingival Diseases, Tooth Plaque, Tooth Diseases

Intervention / Treatment
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* Procedure: Heavy Force (225g)
* Procedure: Light Force (25g)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patients with impaction except impacted third molars for referral to do CBCT, Smokers, 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adult orthodontic patients
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Upper First Premolar One Side<br>Heavy force (225 g) | Procedure: Heavy Force (225g)<br>* Orthodontic Force<br>|
| Experimental: Upper First Premolar Other Side<br>Light Force (25 g) | Procedure: Light Force (25g)<br>* Orthodontic Force<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of Orthodontic Root Resorption | To monitor change in profiling of GCF proteins associated with orthodontically induced root resorption during 4 weeks after orthodontic force application | Baseline, 1hour, 1day, 7days, 14days, 21days and 28days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCF Flow Rate and Orthodontic Force | To determine the impact of different orthodontic force magnitudes on GCF flow rate | Baseline, 1hour, 1day, 7days, 14days, 21days and 28days | 
| Root Resorption Surface Area | To estimate the amount of resorption area in different force groups. | After 28 days of force application. | 
| Protein concentration in Orthodontic GCF | To evaluate the amount of protein content in GCF of orthodontic patients at different force magnitudes. | Baseline, 1hour, 1day, 7days, 14days, 21days and 28days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteomic, Orthodontic Root Resorption, Gingival Crevicular Fluid