Proteomics and Orthodontic Root Resorption

February 27, 2020 updated by: Harraa S. Mohammed-Salih, University of Baghdad

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
      • Baghdad, Iraq
        • Harraa Sabah Mohammed-Salih

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 32 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Upper First Premolar One Side
Heavy force (225 g)
Procedure: Heavy Force (225g)
Orthodontic Force
Experimental: Upper First Premolar Other Side
Light Force (25 g)
Procedure: Light Force (25g)
Orthodontic Force

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers of Orthodontic Root Resorption
Time Frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF Flow Rate and Orthodontic Force
Time Frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
To determine the impact of different orthodontic force magnitudes on GCF flow rate
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Root Resorption Surface Area
Time Frame: After 28 days of force application.
To estimate the amount of resorption area in different force groups.
After 28 days of force application.
Protein concentration in Orthodontic GCF
Time Frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
To evaluate the amount of protein content in GCF of orthodontic patients at different force magnitudes.
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-Study Bone Assessment
Time Frame: Before actual enrolment.
To evaluate the amount of bone density (Hounsfield Unit, HU) around the experimental teeth in CBCT.
Before actual enrolment.
Pre-Study Root Length Assessment
Time Frame: Before actual enrolment.
To evaluate the root length (mm) of the experimental teeth in CBCT.
Before actual enrolment.
Pre-Study Root Shape Assessment
Time Frame: Before actual enrolment.
To evaluate the root shape (Curved or Straight) of the experimental teeth by using CBCT.
Before actual enrolment.
Pre-Study Root Resorption Assessment
Time Frame: Before actual enrolment.
To evaluate the existence of previous apical root resorption (scoring index by Malmgren < Grade 1) of the experimental teeth by using CBCT.
Before actual enrolment.
Oral Health Assessment
Time Frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Plaque Index (PI) was monitored by using modified Silness and Löe Index.
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Oral Health Assessment
Time Frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Gingival Index was monitored by using modified Silness and Löe Index.
Baseline, 1hour, 1day, 7days, 14days, 21days and 28days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Harraa S. Mohammed-Salih, MSc., University of Baghdad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 023418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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