Miniscrews as Anchorage Device for Orthodontic Treatment

Summary

The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.

The hypotheses are:

* that placement of miniscrews does not cause more pain or discomfort than premolar extractions
* that molarblock provides increase of anchorage
* that miniscrews have a better anchorage capacity than molarblock
* that miniscrews are more cost-efficient than conventional anchorage techniques

Conditions

• Orthodontic Anchorage Procedures
• Orthodontic Space Closure

Interventions

DRUG

Topical anesthesia (buccal and palatal)

Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.

DRUG

Local anesthesia (buccal and palatal)

Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).

PROCEDURE

Extraction of the maxillary first premolars

Careful extraction of the maxillary first premolars after mobilization.

DRUG

Topical anesthesia (buccal)

Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.

DRUG

Local anesthesia (buccal)

Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).

DEVICE

Molarblock

Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.

DEVICE

Spider Screw K1 short neck

The Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used.

Sponsors & Collaborators

• Malmö University

  collaborator OTHER

• Department of Research and Development, County Council of Gavleborg and Uppsala University

  collaborator UNKNOWN

• Swedish Dental Associations Scientific Funds

  collaborator UNKNOWN

• Thuréus Foundation for the Promotion of Dental Science, Uppsala University, Sweden

  collaborator UNKNOWN

• Region Gävleborg

  lead OTHER

Principal Investigators

• Lars Bondemark, Professor · Malmö University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

11 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-11-30

Primary Completion

2018-07-31

Completion

2018-09-21

Countries

• Sweden

Study Locations