Efficacy of Skeletal Anchorage (MINISCREW)

Tooth Extraction Status Nos Clinical Trial

— Minivis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025141
• Other study ID #: P070610
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: December 20, 2017
• Start date: February 25, 2009
• Est. completion date: February 20, 2014

Study information

• Verified date: December 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: February 20, 2014
• Est. primary completion date: February 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction Status Nos

Intervention

Device:
• Skeletal anchorage (MINISCREW)
Skeletal anchorage
• dental anchorage
dental anchorage (reference)

Locations

Country	Name	City	State
France	Bretonneau Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	DENTOS

Country where clinical trial is conducted

France, 

Outcome

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