Miniscrews as Anchorage Device for Orthodontic Treatment

February 26, 2019 updated by: Niels Ganzer, Region Gävleborg

Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After informed consent participants are randomized into Group A and B. The treatment starts with extractions of the maxillary first premolars. Extractions are performed by the participants´ general practitioner. Orthodontic treatment starts after the tooth extractions.

All participants get treatment with fixed appliance according to the straight wire concept (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.

The following measurements are taken at:

T0 (Before treatment start): Study models, baseline questionnaire,

T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after tooth extractions.

T2 (After miniscrew placement (Group A), Before space closure): Study models, cephalographic x-ray, questionnaire at the evening after miniscrew placement, questionnaire one week after miniscrew placement.

T3 (After space closure and miniscrew removal): Study models, cephalographic x-ray, questionnaire after screw removal

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Gävleborgs Län
      • Gävle, Gävleborgs Län, Sweden, 80102
        • Specialisttandvården Ortodonti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adolescents in need of orthodontic treatment with fixed appliance including extractions of the maxillary first premolars
  • Need for Anchorage reinforcement
  • Permanent dentition including the maxillary second molars in occlusion (DS4M2 according to Björk)
  • Regular dental care in Sweden since the age of three.

Exclusion Criteria:

  • Experience of previous orthodontic treatment
  • Need for orthognathic surgery
  • Need for maximum anchorage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A - Miniscrews

Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal). Extraction of the maxillary first premolars.

Fixed appliance in the maxilla or maxilla and mandible.

Anchorage reinforcement with miniscrews (Spider Screw K1 short neck). Miniscrews are placed buccally between the maxillary second premolar and the first molar after topical anesthesia (buccal) and injection (buccal). Miniscrews are placed when space closure starts. Space closure is performed as en masse retraction. Miniscrew are immediately loaded with 150g Nickel Titanium coil springs.
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.
Other Names:
  • Anesthesic Jelly (buccal and palatal)
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).
Other Names:
  • Injection (buccal and palatal)
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.
Other Names:
  • Anesthesic Jelly (buccal)
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).
Other Names:
  • Injection (buccal)
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.
Other Names:
  • Temporary anchorage device
  • TAD
  • Orthodontic mini-implant
Active Comparator: Group B - Molarblock

Topical anesthesia (buccal and palatal) followed by local anesthesia (buccal and palatal. Extraction of the maxillary first premolars.

Fixed appliance in the maxilla or maxilla and mandible.

Anchorage reinforcement with molarblocks - a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar. Molarblocks are installed from the beginning of leveling and alignment. Space closure is performed as en masse retraction with type one active tie-backs.
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.
Other Names:
  • Anesthesic Jelly (buccal and palatal)
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).
Other Names:
  • Injection (buccal and palatal)
Procedure: Extraction of the maxillary first premolars
Careful extraction of the maxillary first premolars after mobilization.
Device: Molarblock
Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tooth Position of the Maxillary Molars During Space Closure
Time Frame: Through Space Closure (T2-T3), an average of 9 months
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
Through Space Closure (T2-T3), an average of 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experience of Pain and Discomfort
Time Frame: Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement
Experiences of pain and discomfort are examined with validated self-report questionnaires.
Baseline, the evening after tooth extractions, one week after tooth extractions, the evening after miniscrew placement, one week after miniscrew placement
Change in Tooth Position of the Maxillary Molars During Levelling and Alignment
Time Frame: Through Levelling and Alignment (T1-T2), an average of 9 months
Tooth movement is assessed in millimeters using superimposition of study models and lateral cephalograms.
Through Levelling and Alignment (T1-T2), an average of 9 months
Societal Costs
Time Frame: Through Study Completion, an average of 2 years
Societal costs are the sum of direct and indirect treatment costs. Direct costs are treatment time in the clinic and used material. Indirect costs are travel costs and costs for parents following the participant to the clinic.
Through Study Completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Gävleborg

Collaborators

Malmö University
Swedish Dental Associations Scientific Funds
Department of Research and Development, County Council of Gavleborg and Uppsala University
Thuréus Foundation for the Promotion of Dental Science, Uppsala University, Sweden

Investigators

  • Study Chair: Lars Bondemark, Professor, Malmö University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 21, 2018

Study Registration Dates

First Submitted

December 18, 2015

First Submitted That Met QC Criteria

December 31, 2015

First Posted (Estimate)

January 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFUG-479851

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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