Tooth Extraction Status NosMinivisNCT01025141
Efficacy of Skeletal Anchorage (MINISCREW)
A study testing Skeletal anchorage (MINISCREW) and dental anchorage in people with Tooth Extraction Status Nos, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Tooth Extraction Status Nos
- What is being tested?
- Skeletal anchorage (MINISCREW) and dental anchorage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 25 Feb 2009to 20 Feb 2014
- 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 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged from 12 to 50 years old
- Patient need orthodontic treatment with extraction of 2 maxillary bicuspid
- Patient has signed informed consent
Who cannot join
- Patient younger than 12 and older than 50 years old
- Patient without social security affiliation
- Patient with a medical condition that indicates against orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
The main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment.
Read the detailed description
Multicenter prospective study on patients aged between 12 and 50 years, requiring orthodontic treatment with premolar extractions and closure of the extraction spaces by distalization of the 6 anterior teeth. In the experimental group (50 patients) distalization will be performed using skeletal anchorage (MINISCREW). In the control group (50 patients), distalization will be by dental anchorage.
The main evaluation criterion will be extraction space closure after 8 months of treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. Evaluations will be made by very precise radiological analysis using 3D CT-scan. Examinations will be done before and after closure of the extraction sites and will assess treatment efficacy using skeletal anchorage versus dental anchorage. Patients will also be requested to complete a satisfaction questionnaire. The study will comprise an inclusion appointment during which patient consent will be obtained and a regular monthly appointment during the 8 months of active treatment and space closure.
- Conditions
- Tooth Extraction Status Nos
- Being tested
- Skeletal anchorage (MINISCREW), dental anchorage
- Keywords
- MINISCREW, space extraction closure, anchorage, Orthodontic Treatment, Extraction of 2 Maxillary Premolar, closing of extraction space, patient aged from 12 to 50 years old
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skeletal anchorage (MINISCREW)Device
Also called Skeletal anchorage
Skeletal anchorage
dental anchorageDevice
Also called dental anchorage (reference)
dental anchorage (reference)
| Study group | Role | What they receive |
|---|---|---|
| MINISCREW | Experimental | device Receives: Device: Skeletal anchorage (MINISCREW) |
| Reference | Active comparator | dental anchorage Receives: Device: dental anchorage |
What is being measured
The primary outcome is the main question the study is designed to answer.
We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account.
Measured: 8 months
Secondary outcomes (5)
MINISCREW stability
Measured: 8 months
Anchorage teeth stability
Measured: 8 months
Success and Failure implantation percentage
Measured: 8 months
MINISCREW surgery difficulty
Measured: during the surgery act
Patient satisfaction
Measured: at 1 month and at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study start25 Feb 2009
- Primary completion20 Feb 2014
- Study completion20 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth Extraction Status NosStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- DENTOS, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Catherine Miller, Dentist, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisClaire Haignere, Dentist, Study chair, Assistance Publique - Hôpitaux de ParisAnne-Charlotte Six, Dentist, Study chair, Assistance Publique - Hôpitaux de ParisAlain Decker, Dentist, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025141
- Sponsor's protocol ID
- P070610
- Acronym
- Minivis
- Status last verified
- Oct 2025
- First submitted
- 29 Sep 2009
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT01025141
- Acronym / sponsor ID
- Minivis / P070610
- Conditions
- Tooth Extraction Status Nos
- Keywords
- MINISCREW, space extraction closure, anchorage, Orthodontic Treatment, Extraction of 2 Maxillary Premolar, closing of extraction space, patient aged from 12 to 50 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- DENTOS, URC-CIC Paris Descartes Necker Cochin
- Study start
- 25 Feb 2009 (actual)
- Primary completion
- 20 Feb 2014 (actual)
- Study completion
- 20 Feb 2014 (actual)
- First posted
- 3 Dec 2009 (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 main objective of the investigators' study is to assess the efficacy of a course of treatment using skeletal anchorage (MINISCREW) as compared with treatment involving dental anchorage (reference) during dentofacial orthopedic treatment.
Detailed description
Multicenter prospective study on patients aged between 12 and 50 years, requiring orthodontic treatment with premolar extractions and closure of the extraction spaces by distalization of the 6 anterior teeth. In the experimental group (50 patients) distalization will be performed using skeletal anchorage (MINISCREW). In the control group (50 patients), distalization will be by dental anchorage.
The main evaluation criterion will be extraction space closure after 8 months of treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. Evaluations will be made by very precise radiological analysis using 3D CT-scan. Examinations will be done before and after closure of the extraction sites and will assess treatment efficacy using skeletal anchorage versus dental anchorage. Patients will also be requested to complete a satisfaction questionnaire. The study will comprise an inclusion appointment during which patient consent will be obtained and a regular monthly appointment during the 8 months of active treatment and space closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MINISCREW | Experimental | Device: Skeletal anchorage (MINISCREW)device |
| Reference | Active comparator | Device: dental anchoragedental anchorage |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged from 12 to 50 years old
- Patient need orthodontic treatment with extraction of 2 maxillary bicuspid
- Patient has signed informed consent
Key exclusion criteria (3 listed)
- Patient younger than 12 and older than 50 years old
- Patient without social security affiliation
- Patient with a medical condition that indicates against orthodontic treatment
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 |
|---|---|---|
| Skeletal anchorage (MINISCREW)Also: Skeletal anchorageSkeletal anchorage | Device | MINISCREW |
| dental anchorageAlso: dental anchorage (reference)dental anchorage (reference) | Device | Reference |
Primary outcome
We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account.
Time frame: 8 months
5 secondary outcomes
MINISCREW stability
Time frame: 8 months
Anchorage teeth stability
Time frame: 8 months
Success and Failure implantation percentage
Time frame: 8 months
MINISCREW surgery difficulty
Time frame: during the surgery act
Patient satisfaction
Time frame: at 1 month and at 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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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.
Catherine Miller, Dentist, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Claire Haignere, Dentist study chair
Assistance Publique - Hôpitaux de Paris
Anne-Charlotte Six, Dentist study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skeletal anchorage (MINISCREW) and dental anchorage in people with Tooth Extraction Status Nos, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 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: finished, as of the sponsor's last update on 20 Nov 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
We measure space extraction close after 8 months treatment. Angle class I cuspid and the parallelism of the dental axes will also be taken into account. (time frame: 8 months). 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 20 Nov 2025.