Overview

This trial is active, not recruiting.

Condition dental dysgnathia
Treatment mini-screw implant
Sponsor Zhejiang University
Start date August 2014
End date December 2015
Trial size 60 participants
Trial identifier NCT02221206, NSF81371167

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
mini-screw implant anchorage-assisted retraction of maxillary incisors
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
regular maximum anchorage

Primary Outcomes

Measure
Root resorption
time frame: 10 months after implant insertion

Eligibility Criteria

Male or female participants from 18 years up to 25 years old.

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

Additional Information

Official title Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
Principal investigator Mengjie Wu, MD, DDS
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
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Zhejiang University.