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

NCT ID: NCT02221206

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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

Conditions

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Dental Dysgnathia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

mini-screw implant anchorage-assisted retraction of maxillary incisors

Group Type ACTIVE_COMPARATOR

Mini-Screw implant

Intervention Type DEVICE

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

Control

regular maximum anchorage

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Mengjie Wu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mengjie Wu, MD, DDS

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, Hospital of Stomatology, Zhejiang University

Locations

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Department of Orthodontics, Hospital of Stomatology, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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NSF81371167

Identifier Type: -

Identifier Source: org_study_id

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