Biological Markers Evaluation of Accelerated Tooth Movement

Not Applicable

• Conditions: Cytokine Measurements; Tooth Movement; Orthodontic Space Closure
• Interventions: Procedure: micro-osteoperforation

• Registration Number: NCT02887547
• Lead Sponsor: University of Sao Paulo

Brief Summary

Gingival Crevicular Fluid samples will be collected using periopapers after accelerated tooth movement technique, results will be assessed with biomarkers levels done using ELISA Assays

Detailed Description

For this prospective study, 22 individuals were selected, with skeletal discrepancies randomly divided into two groups: 1 - accelerated tooth movement technique (ATMT) and 2 - Control.

Orthodontic records done in two times, initial and preoperative; Gingival Crevicular Fluid samples will be collected using periopapers in 7 times (1, 2, 7, 14, 28 days and after space closure- end of orthodontic treatment movement activation).

Flapless cortical perforations will be made in ATMT Group after dental extraction. Surgical protocol will be flapless to preserve periodontal health.

After extraction space closure, results will be assessed by clinical effects with biological markers levels:

CCL3/MIP-1 alpha, CCL5/RANTES, CXCL8/IL8, IL-1 alpha, IL-1 beta, IL6, TNF-alpha, TRANCE/RANK L, OCN OPG IL-10 VEGF TGF-ℬ

Those biomarkers levels will be performed using ELISA Assays. After collecting data, the results will be statistically analyzed using Shapiro-Wilk and, posteriorly, T-student or Wilcoxon.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2015-12-20
• Study Start: 2016-08
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-02
• Primary Completion: 2018-02
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-26
• Last Update Posted: 2019-07-01
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Adult subjects ages 18-40 years old, in good general health, with adult complete dentition, regardless of presence of third molars.
• Indication for orthognathic surgery
• Tooth extraction indication for orthodontic treatment
• Do not smoke
• Periodontal and teeth healthy
• Do not use bisphosphonates or corticosteroids

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Exclusion Criteria

• Surgically assisted rapid palatal expansion indication
• Cleft lip and palate
• Craniofacial syndrome
• Mental disorder
• Metabolic diseases

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acceleration	micro-osteoperforation	Group with micro-osteoperforation for accelerated tooth movement during anterior retraction, Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process

Primary Outcome Measures

Name	Time	Method
Inflammatory Cytokines ad Chemokines Detection Assay	8 months	Measure the different levels of listed cytokines and chemokines after starting the anterior retraction
Bone remodeling markers in GCF samples	8 monnths	Measure the different levels of resorption biomarkers and bone formation after starting the anterior retraction