Proteomics and Orthodontic Root Resorption

Sponsor

University of Baghdad (Other)

Overall Status

Completed

CT.gov ID

NCT04291443

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Root Resorption Orthodontic Appliance Complication Orthodontic Pathological Resorption of External Root Gingival Diseases Tooth Plaque Tooth Diseases	Procedure: Heavy Force (225g) Procedure: Light Force (25g)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Adult orthodontic patientsAdult orthodontic patients

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Diagnostic

Official Title:

Detection of Orthodontically Induced Inflammatory Root Resorption From Gingival Crevicular Fluid by Proteomics Analysis: Split Mouth, Randomized Clinical Trial

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Biomarkers of Orthodontic Root Resorption [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

Secondary Outcome Measures

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

Other Outcome Measures

Pre-Study Bone Assessment [Before actual enrolment.]
To evaluate the amount of bone density (Hounsfield Unit, HU) around the experimental teeth in CBCT.
Pre-Study Root Length Assessment [Before actual enrolment.]
To evaluate the root length (mm) of the experimental teeth in CBCT.
Pre-Study Root Shape Assessment [Before actual enrolment.]
To evaluate the root shape (Curved or Straight) of the experimental teeth by using CBCT.
Pre-Study Root Resorption Assessment [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.
Oral Health Assessment [Baseline, 1hour, 1day, 7days, 14days, 21days and 28days]
Plaque Index (PI) was monitored by using modified Silness and Löe Index.
Oral Health Assessment [Baseline, 1hour, 1day, 7days, 14days, 21days and 28days]
Gingival Index was monitored by using modified Silness and Löe Index.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 32 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.