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

Dental Dysgnathia Clinical Trial

Official title:

Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02221206
• Other study ID #: NSF81371167
• Status: Active, not recruiting
• Phase: N/A
• First received: August 18, 2014
• Last updated: September 17, 2014
• Start date: August 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Dysgnathia
• Root Resorption

Intervention

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

Locations

Country	Name	City	State
China	Department of Orthodontics, Hospital of Stomatology, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Root resorption	orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis	10 months after implant insertion	No