Biological Markers Evaluation of Accelerated Tooth Movement

NCT ID: NCT02887547

Last Updated: 2019-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Cytokine Measurements Orthodontic Space Closure Tooth Movement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

micro-osteoperforation

Intervention Type PROCEDURE

Interventions

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micro-osteoperforation

Intervention Type PROCEDURE

Other Intervention Names

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accelerated tooth movement

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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LIANA FATTORI ABATI

MS, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liana Fattori, MS PhD

Role: PRINCIPAL_INVESTIGATOR

Phd candidate

Jose Rino Neto

Role: STUDY_CHAIR

University of Sao Paulo

Other Identifiers

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Fattori2

Identifier Type: -

Identifier Source: org_study_id

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