Clinical trial NCT04291443: Proteomics and Orthodontic Root Resorption
Official title: Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Root Resorption
Orthodontic Appliance Complication
Orthodontic Pathological Resorption of External Root
Gingival Diseases
Tooth Plaque
Tooth Diseases
Keywords: Proteomic
Orthodontic Root Resorption
Gingival Crevicular Fluid
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adult orthodontic patients
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarkers of Orthodontic Root Resorption
timeFrame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Secondary outcomes:
measure: GCF Flow Rate and Orthodontic Force
timeFrame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
measure: Root Resorption Surface Area
timeFrame: After 28 days of force application.
measure: Protein concentration in Orthodontic GCF
timeFrame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Other outcomes:
measure: Pre-Study Bone Assessment
timeFrame: Before actual enrolment.
measure: Pre-Study Root Length Assessment
timeFrame: Before actual enrolment.
measure: Pre-Study Root Shape Assessment
timeFrame: Before actual enrolment.
measure: Pre-Study Root Resorption Assessment
timeFrame: Before actual enrolment.
measure: Oral Health Assessment
timeFrame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
measure: Oral Health Assessment
timeFrame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Locations:
city: Baghdad
country: Iraq
facility: Harraa Sabah Mohammed-Salih
Study officials:
affiliation: University of Baghdad
name: Harraa S. Mohammed-Salih, MSc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saloom HF, Papageorgiou SN, Carpenter GH, Cobourne MT. Impact of Obesity on Orthodontic Tooth Movement in Adolescents: A Prospective Clinical Cohort Study. J Dent Res. 2017 May;96(5):547-554. doi: 10.1177/0022034516688448. Epub 2017 Jan 23.
citation: Rody WJ Jr, Holliday LS, McHugh KP, Wallet SM, Spicer V, Krokhin O. Mass spectrometry analysis of gingival crevicular fluid in the presence of external root resorption. Am J Orthod Dentofacial Orthop. 2014 Jun;145(6):787-98. doi: 10.1016/j.ajodo.2014.03.013.