NCT02887547

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 1, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

December 20, 2015

Last Update Submit

June 26, 2019

Conditions

Cytokine MeasurementsOrthodontic Space ClosureTooth Movement

Outcome Measures

Primary Outcomes (2)

  • Inflammatory Cytokines ad Chemokines Detection Assay

    Measure the different levels of listed cytokines and chemokines after starting the anterior retraction

    8 months

  • Bone remodeling markers in GCF samples

    Measure the different levels of resorption biomarkers and bone formation after starting the anterior retraction

    8 monnths

Study Arms (2)

Control

NO INTERVENTION

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

Acceleration

EXPERIMENTAL

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

Interventions

micro-osteoperforationPROCEDURE
Also known as: accelerated tooth movement
Acceleration

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Liana Fattori, MS PhD

    Phd candidate

    PRINCIPAL INVESTIGATOR

  • Jose Rino Neto

    University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS, PhD

Study Record Dates

First Submitted

December 20, 2015

First Posted

September 2, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2018

Study Completion

May 1, 2020

Last Updated

July 1, 2019

Record last verified: 2019-06