Proteomics and Orthodontic Root Resorption

Orthodontic Appliance Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04291443
• Other study ID #: 023418
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: February 2020
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Diseases
• Orthodontic Appliance Complication
• Orthodontic Pathological Resorption of External Root
• Root Resorption
• Tooth Diseases
• Tooth Plaque
• Tooth Resorption

Intervention

Procedure:
• Heavy Force (225g)
Orthodontic Force
• Light Force (25g)
Orthodontic Force

Locations

Country	Name	City	State
Iraq	Harraa Sabah Mohammed-Salih	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pre-Study Bone Assessment	To evaluate the amount of bone density (Hounsfield Unit, HU) around the experimental teeth in CBCT.	Before actual enrolment.
Other	Pre-Study Root Length Assessment	To evaluate the root length (mm) of the experimental teeth in CBCT.	Before actual enrolment.
Other	Pre-Study Root Shape Assessment	To evaluate the root shape (Curved or Straight) of the experimental teeth by using CBCT.	Before actual enrolment.
Other	Pre-Study Root Resorption Assessment	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.
Other	Oral Health Assessment	Plaque Index (PI) was monitored by using modified Silness and Löe Index.	Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Other	Oral Health Assessment	Gingival Index was monitored by using modified Silness and Löe Index.	Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Primary	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	GCF Flow Rate and Orthodontic Force	To determine the impact of different orthodontic force magnitudes on GCF flow rate	Baseline, 1hour, 1day, 7days, 14days, 21days and 28days
Secondary	Root Resorption Surface Area	To estimate the amount of resorption area in different force groups.	After 28 days of force application.
Secondary	Protein concentration in Orthodontic GCF	To evaluate the amount of protein content in GCF of orthodontic patients at different force magnitudes.	Baseline, 1hour, 1day, 7days, 14days, 21days and 28days

External Links

•   Orthodontic Root Resorption