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Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors

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ClinicalTrials.gov Identifier: NCT02221206
Recruitment Status : Unknown
Verified September 2014 by Mengjie Wu, Zhejiang University.
Recruitment status was:  Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The intended study is designed as a prospective randomized controlled trial (RCT), comparing and contrasting the effect of mini-screw implant anchorage-assisted versus regular maximum anchorage by retracting the maxillary incisors.

Condition or disease Intervention/treatment
Dental Dysgnathia Device: Mini-Screw implant

Detailed Description:

The objective of the clinical study proposal will be to investigate the performance of early root resorption in order to find out if the magnitude and direction of retraction is appropriate for the retraction of maxillary incisors following the mini-screw anchorage.

Therefore, the study will compare and contrast the efficacy and results of the volumetric measurement by CBCT.

Patients

Males or females whose diagnoses require implant anchorage treatment will be included in the study. Inclusion criteria for the study are as followings:

Orthodontic indication for skeletal anchorage Adequate bone quantity for a palatal implant in the CBCT Good oral hygiene and normal wound healing capacity


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Study Start Date : August 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Treatment
mini-screw implant anchorage-assisted retraction of maxillary incisors
Device: Mini-Screw implant
Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides
No Intervention: Control
regular maximum anchorage


Outcome Measures

Primary Outcome Measures :
  1. Root resorption [ Time Frame: 10 months after implant insertion ]
    orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Orthodontic indication for skeletal anchorage
  • Adequate bone quantity for a palatal implant in the CBCT
  • Good oral hygiene and normal wound healing capacity

Exclusion Criteria:

  • Patients with cheilognathopalatoschisis and other system syndromes associated with craniofacial anomalies
  • Patients with immunodeficiency, diseases requiring a prolonged steroid usage, previous radiation therapy or chemotherapy
  • Patients with metabolic bone diseases or uncontrolled endocrine disorders
  • Alcohol or drug abuse
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221206


Locations
China, Zhejiang
Department of Orthodontics, Hospital of Stomatology, Zhejiang University
Hangzhou, Zhejiang, China, 310006
Sponsors and Collaborators
Zhejiang University
Investigators
Principal Investigator: Mengjie Wu, MD, DDS Department of Orthodontics, Hospital of Stomatology, Zhejiang University
More Information

Responsible Party: Mengjie Wu, Associate Professor, Zhejiang University
ClinicalTrials.gov Identifier: NCT02221206     History of Changes
Other Study ID Numbers: NSF81371167
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by Mengjie Wu, Zhejiang University:
Mini-Screw implant anchorage
retraction of maxillary incisors

Additional relevant MeSH terms:
Root Resorption
Tooth Resorption
Tooth Diseases
Stomatognathic Diseases