Efficacy of Skeletal Anchorage (MINISCREW)

Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01025141

Acronym

Minivis

Enrollment

Registered

2009-12-03

Start date

2009-02-25

Completion date

2014-02-20

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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.

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.

Interventions

DEVICESkeletal anchorage (MINISCREW)

Skeletal anchorage

DEVICEdental anchorage

dental anchorage (reference)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Aged from 12 to 50 years old * Patient need orthodontic treatment with extraction of 2 maxillary bicuspid * Patient has signed informed consent

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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.	8 months

Secondary

Measure	Time frame
MINISCREW stability	8 months
Anchorage teeth stability	8 months
Success and Failure implantation percentage	8 months
MINISCREW surgery difficulty	during the surgery act
Patient satisfaction	at 1 month and at 8 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026