This trial is active, not recruiting.

Condition tooth extraction status nos
Treatments skeletal anchorage (miniscrew), dental anchorage
Sponsor Assistance Publique - Hôpitaux de Paris
Collaborator DENTOS
Start date February 2009
End date April 2015
Trial size 99 participants
Trial identifier NCT01025141, P070610


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
skeletal anchorage (miniscrew) Skeletal anchorage
Skeletal anchorage
(Active Comparator)
dental anchorage
dental anchorage dental anchorage (reference)
dental anchorage (reference)

Primary Outcomes

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 Outcomes

MINISCREW stability
time frame: 8 months
Anchorage teeth stability
time frame: 8 months
Success and Failure implantation percentage
time frame: 8 months
MINISCREW surgery difficulty
time frame: during the surgery act
Patient satisfaction
time frame: at 1 month and at 8 months

Eligibility Criteria

Male or female participants from 12 years up to 50 years old.

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

Additional Information

Official title Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment
Principal investigator Catherine Miller, Dentist, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.