Clinical trial NCT01025141: Efficacy of Skeletal Anchorage (MINISCREW)
Official title: Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: DENTOS
First posted: 2009-12-03
Enrollment: 99
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 8 months
Secondary outcomes:
measure: MINISCREW stability
timeFrame: 8 months
measure: Anchorage teeth stability
timeFrame: 8 months
measure: Success and Failure implantation percentage
timeFrame: 8 months
measure: MINISCREW surgery difficulty
timeFrame: during the surgery act
measure: Patient satisfaction
timeFrame: at 1 month and at 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Bretonneau Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Catherine Miller, Dentist, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Claire Haignere, Dentist
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne-Charlotte Six, Dentist
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain Decker, Dentist, PhD
role: STUDY_CHAIR
References: