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

Not Applicable

• Conditions: Dental Dysgnathia
• Interventions: Device: Mini-Screw implant

• Registration Number: NCT02221206
• Lead Sponsor: Zhejiang University

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

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-18
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-19
• Primary Completion: 2015-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Mini-Screw implant	mini-screw implant anchorage-assisted retraction of maxillary incisors

Primary Outcome Measures

Name	Time	Method
Root resorption	10 months after implant insertion	orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis

Trial Locations

Locations (1)

Department of Orthodontics, Hospital of Stomatology, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China