Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Primary Purpose
Dental Dysgnathia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mini-Screw implant
Sponsored by
About this trial
This is an interventional treatment trial for Dental Dysgnathia focused on measuring Mini-Screw implant anchorage, retraction of maxillary incisors
Eligibility 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
Sites / Locations
- Department of Orthodontics, Hospital of Stomatology, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Treatment
Control
Arm Description
mini-screw implant anchorage-assisted retraction of maxillary incisors
regular maximum anchorage
Outcomes
Primary Outcome Measures
Root resorption
orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT02221206
First Posted
August 18, 2014
Last Updated
September 17, 2014
Sponsor
Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT02221206
Brief Title
Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Official Title
Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Dysgnathia
Keywords
Mini-Screw implant anchorage, retraction of maxillary incisors
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
mini-screw implant anchorage-assisted retraction of maxillary incisors
Arm Title
Control
Arm Type
No Intervention
Arm Description
regular maximum anchorage
Intervention Type
Device
Intervention Name(s)
Mini-Screw implant
Intervention Description
Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides
Primary Outcome Measure Information:
Title
Root resorption
Description
orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis
Time Frame
10 months after implant insertion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mengjie Wu, MD, DDS
Organizational Affiliation
Department of Orthodontics, Hospital of Stomatology, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthodontics, Hospital of Stomatology, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
12. IPD Sharing Statement
Learn more about this trial
Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
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