Biological Effects of Commercial Orthodontic Miniscrews

NCT03460132 | Unknown DMC

• 1 other identifier: Al-Azhar 201
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The use of miniscrew implants as an anchorage device in orthodontics has gained a widespread acceptance in recent years. There prevailed use has been attributed to its ease in insertion and removal at a relatively low cost with no need to wait for a long time between miniscrew insertion and force application. In this regard; clinical studies have suggested that miniscrew implants may provide stable anchorage during the orthodontic treatment without requiring patient cooperation. These studies proved many successful applications in orthodontics involving; retraction of anterior teeth, correction of open bites, distalization, mesialization, and intrusion of teeth

Conditions

Cytotoxicity

Keywords

orthodontic miniscrews; biological effect; cytotoxicity; metal release

Outcome Measures

Primary Outcomes (1)

• cytotoxicity of orthodontic miniscrew implant

  Time dependent change in the percentage (%) of dead cells in series of swab samples harvested from area around orthodontic miniscrew implant.

  4 months after initiation of the orthodontic canine retraction

Secondary Outcomes (2)

• Metal release of orthodontic miniscrew implant

  4 months after initiation of the orthodontic canine retraction

• surface changes of orthodontic miniscrew implants

  4 months after initiation of the orthodontic canine retraction

Study Arms (1)

Extraction cases

EXPERIMENTAL

patients receive Tomas orthodontic miniscrew implant as a mean of anchorage augmentation

Device: Tomas® Anchorage System - DENTAURUM

Interventions

Tomas® Anchorage System - DENTAURUM DEVICE

self drilling, bone inserted, screw like device used for anchorage preparation during orthodontic treatment.

Extraction cases

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The patients will be included in this study if they have the following:
• All cases indicated for bilateral extraction of maxillary first premolar and retraction of canine into the extraction space.
• Age range from 14 to 18 years.
• Full set of permanent teeth (the third molars are not considered).
• No previous orthodontic or orthognathic surgery treatment.
• Good oral and general health.
• All teeth should be caries-free.
• All teeth should be free from any metallic restorations.

You may not qualify if:

• The patients will be excluded from the study if they have the following:
• History of serious medical problems or taking systemic medication which could affect orthodontic treatment.
• History of serious dental problems (endodontic treatment, apicectomy, or any other dental problems) which could affect orthodontic treatment.

Sponsors & Collaborators

• Al-Azhar University: lead

Central Study Contacts

Ahmed Shehata M. Ammar, PhD

CONTACT

01008180248; ahmed.sh.amar@azhar.edu.eg

khaled M. Taha, Master

CONTACT

01094556203; kh.taha@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 9, 2018
• Study Start: May 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-03