Efficacy of Skeletal Anchorage (MINISCREW) (Minivis)

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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction Status Nos
• Intervention / Treatment: Device: Skeletal anchorage (MINISCREW); Device: dental anchorage

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bretonneau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MINISCREW; device	Device: Skeletal anchorage (MINISCREW); Skeletal anchorage; Other Names: Skeletal anchorage
Active Comparator: Reference; dental anchorage	Device: dental anchorage; dental anchorage (reference); Other Names: dental anchorage (reference)

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: DENTOS
• Investigators: Principal Investigator: Catherine Miller, Dentist, PhD, Assistance Publique - Hôpitaux de Paris; Study Chair: Claire Haignere, Dentist, Assistance Publique - Hôpitaux de Paris; Study Chair: Anne-Charlotte Six, Dentist, Assistance Publique - Hôpitaux de Paris; Study Chair: Alain Decker, Dentist, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2009
• Primary Completion (Actual): February 20, 2014
• Study Completion (Actual): February 20, 2014

Study Registration Dates

• First Submitted: September 29, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Orthodontic Treatment; anchorage; MINISCREW; space extraction closure; Extraction of 2 Maxillary Premolar; closing of extraction space; patient aged from 12 to 50 years old
• Other Study ID Numbers: P070610