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Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
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.
Age
18 - 32 years
Sex
ALL
Healthy Volunteers
Yes
Harraa Sabah Mohammed-Salih
Baghdad, Iraq
Start Date
March 1, 2019
Primary Completion Date
July 1, 2019
Completion Date
July 1, 2019
Last Updated
March 2, 2020
20
ACTUAL participants
Heavy Force (225g)
PROCEDURE
Light Force (25g)
PROCEDURE
Lead Sponsor
University of Baghdad
NCT06199674
NCT07458139
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07276984