CytotoxicityNCT03460132
Biological Effects of Commercial Orthodontic Miniscrews
A study testing Tomas® Anchorage System - DENTAURUM in people with Cytotoxicity, run by Al-Azhar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cytotoxicity
- What is being tested?
- Tomas® Anchorage System - DENTAURUM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 1 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Biological Effects of Commercial Orthodontic Miniscrews on the Oral Investing Tissue
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
Read the 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.
- Conditions
- Cytotoxicity
- Being tested
- Tomas® Anchorage System - DENTAURUM
- Keywords
- orthodontic miniscrews, biological effect, cytotoxicity, metal release
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tomas® Anchorage System - DENTAURUMDevice
self drilling, bone inserted, screw like device used for anchorage preparation during orthodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Extraction cases | Experimental | patients receive Tomas orthodontic miniscrew implant as a mean of anchorage augmentation Receives: Device: Tomas® Anchorage System - DENTAURUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months after initiation of the orthodontic canine retraction
Secondary outcomes (2)
Metal release of orthodontic miniscrew implant
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.
Measured: 4 months after initiation of the orthodontic canine retraction
surface changes of orthodontic miniscrew implants
surface analysis of orthodontic miniscrew implant (mass percentage) by X-ray fluorescence
Measured: 4 months after initiation of the orthodontic canine retraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 May 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytotoxicityStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed S.M. Ammar, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460132
- Sponsor's protocol ID
- Al-Azhar 201
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biological Effects of Commercial Orthodontic Miniscrews on the Oral Investing Tissue
- ClinicalTrials.gov ID
- NCT03460132
- Acronym / sponsor ID
- Al-Azhar 201
- Conditions
- Cytotoxicity
- Keywords
- orthodontic miniscrews, biological effect, cytotoxicity, metal release
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extraction cases | Experimental | Device: Tomas® Anchorage System - DENTAURUMpatients receive Tomas orthodontic miniscrew implant as a mean of anchorage augmentation |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- The patients will be included in this study if they have the following:
Key exclusion criteria (3 listed)
- The patients will be excluded from the study if they have the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tomas® Anchorage System - DENTAURUMself drilling, bone inserted, screw like device used for anchorage preparation during orthodontic treatment. | Device | Extraction cases |
Primary outcome
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.
2 secondary outcomes
Metal release of orthodontic miniscrew implant
Time frame: 4 months after initiation of the orthodontic canine retraction
surface changes of orthodontic miniscrew implants
Time frame: 4 months after initiation of the orthodontic canine retraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Tomas® Anchorage System - DENTAURUM in people with Cytotoxicity, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Shehata M. Ammar, PhD (01008180248 ext. +2, ahmed.sh.amar@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytotoxicity of orthodontic miniscrew implant (time frame: 4 months after initiation of the orthodontic canine retraction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.