NCT01025141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2014

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

September 29, 2009

Last Update Submit

November 17, 2025

Conditions

Tooth Extraction Status Nos

Keywords

MINISCREWspace extraction closureanchorageOrthodontic TreatmentExtraction of 2 Maxillary Premolarclosing of extraction spacepatient aged from 12 to 50 years old

Outcome Measures

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.

    8 months

Secondary Outcomes (5)

  • MINISCREW stability

    8 months

  • Anchorage teeth stability

    8 months

  • Success and Failure implantation percentage

    8 months

  • MINISCREW surgery difficulty

    during the surgery act

  • Patient satisfaction

    at 1 month and at 8 months

Study Arms (2)

MINISCREW

EXPERIMENTAL

device

Device: Skeletal anchorage (MINISCREW)

Reference

ACTIVE COMPARATOR

dental anchorage

Device: dental anchorage

Interventions

Skeletal anchorage (MINISCREW)DEVICE

Skeletal anchorage

Also known as: Skeletal anchorage
MINISCREW
dental anchorageDEVICE

dental anchorage (reference)

Also known as: dental anchorage (reference)
Reference

Eligibility Criteria

Age12 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged from 12 to 50 years old
  • Patient need orthodontic treatment with extraction of 2 maxillary bicuspid
  • Patient has signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bretonneau Hospital

Paris, 75018, France

Location

Study Officials

  • Catherine Miller, Dentist, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2009

First Posted

December 3, 2009

Study Start

February 25, 2009

Primary Completion

February 20, 2014

Study Completion

February 20, 2014

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)