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Completed

NCT Number: NCT01025141

Efficacy of Skeletal Anchorage (MINISCREW)

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.

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Key information

Age range

12 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bretonneau Hospital

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skeletal anchorage (MINISCREW)

Device

Skeletal anchorage

Other names: Skeletal anchorage

dental anchorage

Device

dental anchorage (reference)

Other names: dental anchorage (reference)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • DENTOS
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Study of the Efficacy of Skeletal Anchorage (MINISCREW) Compared to Dental Anchorage During Orthodontic Treatment

Acronym: Minivis

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Dec 3, 2009
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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