Biological Markers Evaluation of Accelerated Tooth Movement

Tooth Movement Clinical Trial

Official title:

Biomarkers Expression in Gingival Crevicular Fluid and Accelerated Tooth Movement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02887547
• Other study ID #: Fattori2
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2016
• Est. completion date: May 2020

Study information

• Verified date: June 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: May 2020
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cytokine Measurements
• Orthodontic Space Closure
• Tooth Movement

Intervention

Procedure:
• micro-osteoperforation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Outcome

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