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Proteomics and Orthodontic Root Resorption

Primary Purpose

Root Resorption, Orthodontic Appliance Complication, Orthodontic Pathological Resorption of External Root

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Heavy Force (225g)
Light Force (25g)
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Root Resorption focused on measuring Proteomic, Orthodontic Root Resorption, Gingival Crevicular Fluid

Eligibility Criteria

18 Years - 32 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harraa Sabah Mohammed-Salih

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upper First Premolar One Side

Upper First Premolar Other Side

Arm Description

Heavy force (225 g)

Light Force (25 g)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

GCF Flow Rate and Orthodontic Force
To determine the impact of different orthodontic force magnitudes on GCF flow rate
Root Resorption Surface Area
To estimate the amount of resorption area in different force groups.
Protein concentration in Orthodontic GCF
To evaluate the amount of protein content in GCF of orthodontic patients at different force magnitudes.

Full Information

First Posted
February 25, 2020
Last Updated
February 27, 2020
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04291443
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adult orthodontic patients
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Upper First Premolar One Side
Arm Type
Experimental
Arm Description
Heavy force (225 g)
Arm Title
Upper First Premolar Other Side
Arm Type
Experimental
Arm Description
Light Force (25 g)
Intervention Type
Procedure
Intervention Name(s)
Heavy Force (225g)
Intervention Description
Orthodontic Force
Intervention Type
Procedure
Intervention Name(s)
Light Force (25g)
Intervention Description
Orthodontic Force
Primary Outcome Measure Information:
Title
Biomarkers of Orthodontic Root Resorption
Description
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
Secondary Outcome Measure Information:
Title
GCF Flow Rate and Orthodontic Force
Description
To determine the impact of different orthodontic force magnitudes on GCF flow rate
Time Frame
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Title
Root Resorption Surface Area
Description
To estimate the amount of resorption area in different force groups.
Time Frame
After 28 days of force application.
Title
Protein concentration in Orthodontic GCF
Description
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
Other Pre-specified Outcome Measures:
Title
Pre-Study Bone Assessment
Description
To evaluate the amount of bone density (Hounsfield Unit, HU) around the experimental teeth in CBCT.
Time Frame
Before actual enrolment.
Title
Pre-Study Root Length Assessment
Description
To evaluate the root length (mm) of the experimental teeth in CBCT.
Time Frame
Before actual enrolment.
Title
Pre-Study Root Shape Assessment
Description
To evaluate the root shape (Curved or Straight) of the experimental teeth by using CBCT.
Time Frame
Before actual enrolment.
Title
Pre-Study Root Resorption Assessment
Description
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.
Title
Oral Health Assessment
Description
Plaque Index (PI) was monitored by using modified Silness and Löe Index.
Time Frame
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Title
Oral Health Assessment
Description
Gingival Index was monitored by using modified Silness and Löe Index.
Time Frame
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
32 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harraa S. Mohammed-Salih, MSc.
Organizational Affiliation
University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harraa Sabah Mohammed-Salih
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28113000
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.
Results Reference
background
PubMed Identifier
24880850
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.
Results Reference
background
Links:
URL
https://medlineplus.gov/
Description
Orthodontic Root Resorption

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Proteomics and Orthodontic Root Resorption

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