Proteomics and Orthodontic Root Resorption

Not Applicable

Completed

• Conditions: Orthodontic Pathological Resorption of External Root; Gingival Diseases; Tooth Diseases; Root Resorption; Tooth Plaque; Orthodontic Appliance Complication
• Interventions: Procedure: Heavy Force (225g); Procedure: Light Force (25g)

• Registration Number: NCT04291443
• Lead Sponsor: University of Baghdad

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.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-27
• Last Update Submitted: 2020-02-27
• Study First Posted: 2020-03-02
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Upper First Premolar One Side	Heavy Force (225g)	Heavy force (225 g)
Upper First Premolar Other Side	Light Force (25g)	Light Force (25 g)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Harraa Sabah Mohammed-Salih; 🇮🇶 Baghdad, Iraq