Efficacy of Skeletal Anchorage (MINISCREW)

NCT ID: NCT01025141

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-25

Study Completion Date

2014-02-20

Brief Summary

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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

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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.

Conditions

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Tooth Extraction Status Nos

Keywords

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MINISCREW space extraction closure anchorage Orthodontic Treatment Extraction of 2 Maxillary Premolar closing of extraction space patient aged from 12 to 50 years old

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MINISCREW

device

Group Type EXPERIMENTAL

Skeletal anchorage (MINISCREW)

Intervention Type DEVICE

Skeletal anchorage

Reference

dental anchorage

Group Type ACTIVE_COMPARATOR

dental anchorage

Intervention Type DEVICE

dental anchorage (reference)

Interventions

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Skeletal anchorage (MINISCREW)

Skeletal anchorage

Intervention Type DEVICE

dental anchorage

dental anchorage (reference)

Intervention Type DEVICE

Other Intervention Names

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Skeletal anchorage dental anchorage (reference)

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DENTOS

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Miller, Dentist, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Claire Haignere, Dentist

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Anne-Charlotte Six, Dentist

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Alain Decker, Dentist, PhD

Role: STUDY_CHAIR

Assistance Publique - Hôpitaux de Paris

Locations

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Bretonneau Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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P070610

Identifier Type: -

Identifier Source: org_study_id