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NCT Number: NCT04291443

Proteomics and Orthodontic Root Resorption

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.

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Key information

Conditions

Root Resorption Dental Deposits Dental Plaque Gingival Diseases Mouth Diseases Orthodontic Appliance Complication Orthodontic Pathological Resorption of External Root Periodontal Diseases Stomatognathic Diseases Tooth Diseases Tooth Plaque Tooth Resorption

Age range

18 year–32 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harraa Sabah Mohammed-Salih

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heavy Force (225g)

Procedure

Orthodontic Force

Light Force (25g)

Procedure

Orthodontic Force

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Root Resorption Surface Area

    Time frame: After 28 days of force application.

    To estimate the amount of resorption area in different force groups.

  3. 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.

Other outcomes

  1. 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.

  2. Pre-Study Root Length Assessment

    Time frame: Before actual enrolment.

    To evaluate the root length (mm) of the experimental teeth in CBCT.

  3. 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.

  4. 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.

  5. 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.

  6. Oral Health Assessment

    Time frame: Baseline, 1hour, 1day, 7days, 14days, 21days and 28days

    Gingival Index was monitored by using modified Silness and Löe Index.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 2, 2020
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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