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Efficacy of Skeletal Anchorage (MINISCREW) (Minivis)

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ClinicalTrials.gov Identifier: NCT01025141
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : December 21, 2017
Sponsor:
Collaborator:
DENTOS
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tooth Extraction Status Nos Device: Skeletal anchorage (MINISCREW) Device: dental anchorage Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
Actual Study Start Date : February 25, 2009
Actual Primary Completion Date : February 20, 2014
Actual Study Completion Date : February 20, 2014
Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. MINISCREW stability [ Time Frame: 8 months ]
  2. Anchorage teeth stability [ Time Frame: 8 months ]
  3. Success and Failure implantation percentage [ Time Frame: 8 months ]
  4. MINISCREW surgery difficulty [ Time Frame: during the surgery act ]
  5. Patient satisfaction [ Time Frame: at 1 month and at 8 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025141


Locations
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France
Bretonneau Hospital
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
DENTOS
Investigators
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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
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Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01025141    
Other Study ID Numbers: P070610
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
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