Biological Markers Evaluation of Accelerated Tooth Movement

June 26, 2019 updated by: LIANA FATTORI ABATI, University of Sao Paulo

Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group, with traditional orthodontic mechanics for anterior retraction. Crevicular fluid will be collected during anterior retraction mechanics to identified biomarkers in the inflammatory process
Experimental: Acceleration
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
Procedure: micro-osteoperforation
Other Names:
  • accelerated tooth movement

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Principal Investigator: Liana Fattori, MS PhD, PhD candidate
  • Study Chair: Jose Rino Neto, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

December 20, 2015

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Fattori2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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