Dental DysgnathiaNCT02221206
Volumetric Analysis of Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
A study testing Mini-Screw implant in people with Dental Dysgnathia, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Dental Dysgnathia
- What is being tested?
- Mini-Screw implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Aug 2014to Dec 2016
- 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Orthodontic indication for skeletal anchorage
- Adequate bone quantity for a palatal implant in the CBCT
- Good oral hygiene and normal wound healing capacity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Orthodontics, Hospital of Stomatology, Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
Official title: Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
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.
Read the 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
- Conditions
- Dental Dysgnathia
- Being tested
- Mini-Screw implant
- Keywords
- Mini-Screw implant anchorage, retraction of maxillary incisors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Screw implantDevice
Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | mini-screw implant anchorage-assisted retraction of maxillary incisors Receives: Device: Mini-Screw implant |
| Control | No intervention | regular maximum anchorage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Root resorption
orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis
Measured: 10 months after implant insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DysgnathiaStudies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mengjie Wu, Zhejiang University
- Investigators
- Mengjie Wu, MD, DDS, Principal investigator, Department of Orthodontics, Hospital of Stomatology, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221206
- Sponsor's protocol ID
- NSF81371167
- Status last verified
- Sep 2014
- First submitted
- 18 Aug 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation for the Root Resorption With Mini-Screw Implant Anchorage-assisted Retraction of Maxillary Incisors
- ClinicalTrials.gov ID
- NCT02221206
- Acronym / sponsor ID
- NSF81371167
- Conditions
- Dental Dysgnathia
- Keywords
- Mini-Screw implant anchorage, retraction of maxillary incisors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Mini-Screw implantmini-screw implant anchorage-assisted retraction of maxillary incisors |
| Control | No intervention | –regular maximum anchorage |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Orthodontic indication for skeletal anchorage
- Adequate bone quantity for a palatal implant in the CBCT
- Good oral hygiene and normal wound healing capacity
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Mini-Screw implantMini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides | Device | Treatment |
Primary outcome
Root resorption
Time frame: 10 months after implant insertion
orthodontic analysis was done by a Cone beam computed tomography (CBCT) analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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.
Mengjie Wu, MD, DDS principal investigator
Department of Orthodontics, Hospital of Stomatology, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-Screw implant in people with Dental Dysgnathia, run by Zhejiang University at 1 site in China.
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 3 inclusion and 5 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root resorption (time frame: 10 months after implant insertion). 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 19 Sep 2014; AzTrials last refreshed its copy on 7 Nov 2026.