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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04291443
Other study ID # 023418
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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