Efficacy of Skeletal Anchorage (MINISCREW)

Not Applicable

Completed

• Conditions: Tooth Extraction Status Nos
• Interventions: Device: dental anchorage; Device: Skeletal anchorage (MINISCREW)

• Registration Number: NCT01025141
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2009-02-25
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2014-02-20
• Study Completion: 2014-02-20
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reference	dental anchorage	dental anchorage
MINISCREW	Skeletal anchorage (MINISCREW)	device

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Bretonneau Hospital; 🇫🇷 Paris, France