NCT02221206

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

August 18, 2014

Last Update Submit

September 17, 2014

Conditions

Dental Dysgnathia

Keywords

Mini-Screw implant anchorageretraction of maxillary incisors

Outcome Measures

Primary Outcomes (1)

  • Root resorption

    orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis

    10 months after implant insertion

Study Arms (2)

Treatment

ACTIVE COMPARATOR

mini-screw implant anchorage-assisted retraction of maxillary incisors

Device: Mini-Screw implant

Control

NO INTERVENTION

regular maximum anchorage

Interventions

Mini-Screw implantDEVICE

Mini-screw implants (VectorTASTM8\*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides

Treatment

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Hospital of Stomatology, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Study Officials

  • Mengjie Wu, MD, DDS

    Department of Orthodontics, Hospital of Stomatology, Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

CN(1)