search
Back to results

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
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 18, 2014
Last Updated
September 17, 2014
Sponsor
Zhejiang University
search

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

We'll reach out to this number within 24 hrs