An interventional study of Heavy Force (225g) and Light Force (25g) in Root Resorption, Orthodontic Appliance Complication and Orthodontic Pathological Resorption of External Root, sponsored by University of Baghdad. Completed at 1 site in Iraq. Open to participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-02.
Sponsored by University of Baghdad · Not applicable, Interventional, and Diagnostic
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.
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.
43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.
This study's enrollment of 20 is below the median of 29 across 36 interventional studies indexed under Root Resorption.
Browse Root Resorption studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Heavy force (225 g)
Procedure: Heavy Force (225g)
Light Force (25 g)
Procedure: Light Force (25g)
Orthodontic Force
Orthodontic Force
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
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
GCF Flow Rate and Orthodontic Force
To determine the impact of different orthodontic force magnitudes on GCF flow rate
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Root Resorption Surface Area
To estimate the amount of resorption area in different force groups.
Time frame: 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.
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Pre-Study Bone Assessment
To evaluate the amount of bone density (Hounsfield Unit, HU) around the experimental teeth in CBCT.
Time frame: Before actual enrolment.
Pre-Study Root Length Assessment
To evaluate the root length (mm) of the experimental teeth in CBCT.
Time frame: Before actual enrolment.
Pre-Study Root Shape Assessment
To evaluate the root shape (Curved or Straight) of the experimental teeth by using CBCT.
Time frame: Before actual enrolment.
Pre-Study Root Resorption Assessment
To evaluate the existence of previous apical root resorption (scoring index by Malmgren \< Grade 1) of the experimental teeth by using CBCT.
Time frame: Before actual enrolment.
Oral Health Assessment
Plaque Index (PI) was monitored by using modified Silness and Löe Index.
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Oral Health Assessment
Gingival Index was monitored by using modified Silness and Löe Index.
Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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