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Efficacy of Skeletal Anchorage (MINISCREW) (Minivis)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
DENTOS
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01025141
First received: September 29, 2009
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Tooth Extraction Status Nos
 Device: Skeletal anchorage (MINISCREW)
Device: dental anchorage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment

Resource links provided by NLM:

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MINISCREW stability [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Anchorage teeth stability [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • Success and Failure implantation percentage [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • MINISCREW surgery difficulty [ Time Frame: during the surgery act ] [ Designated as safety issue: Yes ]
  • Patient satisfaction [ Time Frame: at 1 month and at 8 months ] [ Designated as safety issue: Yes ]

Enrollment: 99
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MINISCREW
device
 Device: Skeletal anchorage (MINISCREW)
Skeletal anchorage
Other Name: Skeletal anchorage
Active Comparator: Reference
dental anchorage
 Device: dental anchorage
dental anchorage (reference)
Other Name: dental anchorage (reference)

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

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025141

Locations
France
Bretonneau Hospital
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01025141     History of Changes
Other Study ID Numbers: P070610
Study First Received: September 29, 2009
Last Updated: July 25, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
MINISCREW
space extraction closure
anchorage
Orthodontic Treatment
 Extraction of 2 Maxillary Premolar
closing of extraction space
patient aged from 12 to 50 years old

ClinicalTrials.gov processed this record on May 21, 2013