Proteomics and Orthodontic Root Resorption
Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedMarch 2, 2020
February 1, 2020
4 months
February 25, 2020
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Other Outcomes (6)
Pre-Study Bone Assessment
Before actual enrolment.
Pre-Study Root Length Assessment
Before actual enrolment.
Pre-Study Root Shape Assessment
Before actual enrolment.
- +3 more other outcomes
Study Arms (2)
Upper First Premolar One Side
EXPERIMENTALHeavy force (225 g)
Upper First Premolar Other Side
EXPERIMENTALLight Force (25 g)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harraa Sabah Mohammed-Salih
Baghdad, Iraq
Related Publications (2)
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.
PMID: 28113000BACKGROUNDRody 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.
PMID: 24880850BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harraa S. Mohammed-Salih, MSc.
University of Baghdad
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 2, 2020
Study Start
March 1, 2019
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share