Three- Dimensional Evaluation of Accelerated Tooth Movement
1 other identifier
interventional
22
1 country
1
Brief Summary
The purpose of this research study is to assess the clinical effectiveness of a minimally invasive alveolar microperforation procedure to achieve accelerated tooth movement in patients undergoing orthodontic treatment for orthognathic surgery. "Accelerated tooth movement" means that Microperforation technique may help complete orthodontic treatment sooner than would be expected in conventional orthodontic treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJune 27, 2019
June 1, 2019
9 months
March 27, 2015
June 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of velocity rate of anterior retraction in conventional mechanics and accelerated tooth movement technique
The micro osteoperforations accelerates tooth moviment - Null hipothesis
6 months
Study Arms (2)
Micro-osteoperforation
EXPERIMENTALMinimally invasive micro-osteoperforation procedure used to achieve accelerated orthodontic tooth movement. Topical and local anesthetic will be delivered in the area to be treated in accordance with standard practice.
Control
NO INTERVENTIONAnterior retraction after premolars extraction will be done conventionally (slide mechanics)
Interventions
Flapless cortical perforations will be made 8 months minimum after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations will be done with manual instrument, between apex to the contour of free gum between the canine and second pre-molar. Perforations near each tooth will have 6-8 mm depth
Eligibility Criteria
You may qualify if:
- Adult subjects aged 18-35 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
FOUSP
São Paulo, 05508000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jose R Neto, PhD
University of Sao Paulo
- STUDY CHAIR
Lucia H Cevidanes, PhD
University of Michigan
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Master degree student
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 15, 2015
Study Start
April 1, 2015
Primary Completion
January 1, 2016
Study Completion
July 1, 2018
Last Updated
June 27, 2019
Record last verified: 2019-06