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

Study Overview
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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

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

Conditions
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Dental Dysgnathia

Intervention / Treatment
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* Device: Mini-Screw implant


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>mini-screw implant anchorage-assisted retraction of maxillary incisors | Device: Mini-Screw implant<br>* Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides<br>|
| No Intervention: Control<br>regular maximum anchorage | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Root resorption | orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis | 10 months after implant insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mini-Screw implant anchorage, retraction of maxillary incisors