Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Biological Effects of Commercial Orthodontic Miniscrews

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460132
Recruitment Status : Unknown
Verified March 2018 by Ahmed S.M. Ammar, Al-Azhar University.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed S.M. Ammar, Al-Azhar University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Cytotoxicity Device: Tomas® Anchorage System - DENTAURUM Not Applicable

Detailed Description:

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.

In dentistry, various materials are used in implant systems. The implant material must be nontoxic, biocompatible, mechanically sufficient, and having high tension and corrosion resistance. Commercially pure titanium (cp Ti) is the most used material in prosthetic implants because of its; high biocompatibility, high corrosion resistance in body fluids, not allergic, high specific strength, and low elastic modulus when compared with other metallic biomaterials.

On the other hand, orthodontic miniscrew implants are smaller than conventional prosthetic implants and should resist high orthodontic loads. These factors contribute to the possible fracture of cp Ti miniscrew implants during placement, use, and removal. To avoid such fracture, Ti alloy implants, composed with aluminum (6Al) and vanadium (4V), (Ti-6Al-4V), for adding strength and fatigue resistance than cp Ti, are required. Unfortunately, this alloy has a low corrosion resistance and can result in corrosion of the orthodontic miniscrew implants in body fluids.

Any metal or alloy implanted in the human body is a potential source of toxicity. In an oral envelope, miniscrew implants are exposed to a number of potentially destructive physical and chemical agents. Evaluation the potential of conventional dental implants to release metallic ions into the body have been done. However, little attention has been given to metallic ion released from orthodontic miniscrew implant systems and the potential toxicity of these released metal on oral tissues. The concern about this has been limited to orthodontic brackets and wires.

One of the studies concerned with the biocompatibility of different metals used in vivo of different fixed orthodontic appliances and evaluating the presence of metal ions in oral mucosa cells, their potential cytotoxicity, and genotoxic effects. This study concluded that nickel and cobalt metals released from fixed orthodontic appliances could induce DNA damage in oral mucosa cells.

Literature review in this topic listed an expanding area of articles dealing with orthodontic miniscrews. The in vivo studies of cytotoxic effect of metal ions released from orthodontic miniscrew implants in body fluids are limited compared to in vitro studies.

In view of the above review of literature, it will be of great value in clinical orthodontics to investigate the biological effect of commercial orthodontic miniscrew implants on the oral investing tissue.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Biological Effects of Commercial Orthodontic Miniscrews on the Oral Investing Tissue
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Extraction cases
patients receive Tomas orthodontic miniscrew implant as a mean of anchorage augmentation
 Device: Tomas® Anchorage System - DENTAURUM
self drilling, bone inserted, screw like device used for anchorage preparation during orthodontic treatment.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. cytotoxicity of orthodontic miniscrew implant [ Time Frame: 4 months after initiation of the orthodontic canine retraction ]
    Time dependent change in the percentage (%) of dead cells in series of swab samples harvested from area around orthodontic miniscrew implant.


Secondary Outcome Measures :
  1. Metal release of orthodontic miniscrew implant [ Time Frame: 4 months after initiation of the orthodontic canine retraction ]
    Time dependent change in the amount (micro-grams, µg) of titanium, aluminum and vanadium traces in series of saliva samples using inductively coupled plasma optical emission spectrometry.

  2. surface changes of orthodontic miniscrew implants [ Time Frame: 4 months after initiation of the orthodontic canine retraction ]
    surface analysis of orthodontic miniscrew implant (mass percentage) by X-ray fluorescence


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The patients will be included in this study if they have the following:

    1. All cases indicated for bilateral extraction of maxillary first premolar and retraction of canine into the extraction space.
    2. Age range from 14 to 18 years.
    3. Full set of permanent teeth (the third molars are not considered).
    4. No previous orthodontic or orthognathic surgery treatment.
    5. Good oral and general health.
    6. All teeth should be caries-free.
    7. All teeth should be free from any metallic restorations.

Exclusion Criteria:

  • The patients will be excluded from the study if they have the following:

    1. History of serious medical problems or taking systemic medication which could affect orthodontic treatment.
    2. History of serious dental problems (endodontic treatment, apicectomy, or any other dental problems) which could affect orthodontic treatment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460132


Contacts
Layout table for location contacts
Contact: Ahmed Shehata M. Ammar, PhD 01008180248 ext +2 ahmed.sh.amar@azhar.edu.eg
Contact: khaled M. Taha, Master 01094556203 ext +2 kh.taha@azhar.edu.eg

Sponsors and Collaborators
Al-Azhar University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed S.M. Ammar, Assistant lecturer, Al-Azhar University
ClinicalTrials.gov Identifier: NCT03460132    
Other Study ID Numbers: Al-Azhar 201
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed S.M. Ammar, Al-Azhar University:
orthodontic miniscrews
biological effect
cytotoxicity
metal release